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Dr. Radwa El Moneer is the Head of Pharmaceutical Policies & Market Access Central Administration at Egyptian Drug Authority (EDA) & also the supervisor of EDA Chairman Office.
Dr. Radwa El Moneer stands as one of the most prominent woman leaders in the field of pharmaceutical regulations in Egypt & …. Africa. Through her influential positions and dedication to improving the pharmaceutical industry, she has made significant contributions to the development and implementation of regulatory policies in the country, in a way that makes her contributions to the pharmaceutical industry in Egypt.
Dr. Mariam Maged is the Manager of human pharmaceuticals Variations Administration at the Egyptian Drug Authority (EDA), where being responsible for all types of post market changes for human pharmaceutical drugs.
She started her career almost 11 years ago in the central administration of pharmaceutical affairs (CAPA) after graduation from faculty of pharmacy Future university with grade excellent with honor, in 2012 started the new career path as a registration specialist in CAPA .In 2020 with establishment of EDA Started a new career as manager of evaluation unit of specification and composition variation until 2021 where promoted to the current title in EDA as Manager of human pharmaceuticals Variations Administration.
She had a bachelor’s degree in pharmaceutical science.
She had a master’s degree in business administration in project management.
She is EDA representative as a member in the African Medicine Regulatory Harmonization (AMRH) Technical Committee on Regulatory Capacity Development (RCD-TC).
She is EDA representative as Chairperson of RCD-TC Subcommittee on Vaccines Regulatory
Oversight.
She was the former head of post approval changes department of biological products.
She was a member in the WHO team for assessing Covid-19 vaccines submitted for EUL.
She was a member in the team of updating registration guideline of biosimilar product in EGYPT.
She was a member in the team of issuing Procedures for Registration of Biological products through Reliance pathways.
She has 19 years’ Experience as Regulator Covering different roles in in various fields as Good Clinical Practice – Good Pharmacovigilance Practice – Regulatory Affairs – Pharmaceutical Production – Quality Assurance – Technical Methodology – GMP Inspection – Health Care Quality , key functions such as Quality Compliance, Documentation, Personnel, Biosafety, Performance Improvement, Validation, and, Strategic Planning, Quality System Management, Management of Quality Function, Project Planning and Initiation, Quality Control Techniques, Production Steps through GMP Trainings and reviewing Manufacturer`s Master files and production summary protocols and working as operation and facility Manager in a Pharmaceutical Company During its renovation phase. And also responsible for assessing and evaluating and monitoring Conduction of different phases of Clinical Trials and also as being QPPV.
Furthermore, she has gained significant experience working through EDA task force through the journey of achieving ML 3 in Vaccine scope according to World Health Organization GBT
Rehab is the Manager of the general Administration of Pharmaceutical References and inserts, Central administration of Pharmaceutical Care, Egyptian Drug Authority
She is a board-certified Pharmacist in pharmacotherapy with a Master’s Degree in the field of clinical biochemistry and oncology
She has completed the clinical research scholarship at Harvard Medical School, postgraduate studies in Policy Development and Advocacy for Global Health at the University of Washington and The advanced leadership skills” training program by the National Training Academy.
Over the span of more than 15 years, Rehab has gained extensive experience in various areas of the life sciences sector, with a focus on Regulatory Affairs, Pharmacovigilance, Patient Safety, Drug/Medicine Information, Medical Affairs, Clinical Pharmacy, and Hospital Accreditation Standards.
In her role as the General Manager of Pharmaceutical References and Leaflets, She and her team lead the Electronic Labelling Project and they feel honored to be pioneers in the Middle East and Africa.
She participated in a number of strategic projects, such as the WHO rational Drug use survey, And also was among many expert Working Committees responsible for achieving the “Egyptian Clinical Pharmacy Standards of Practice”, “Egyptian guidelines of Medication Management standards” and Guidelines for Classification as Nonprescription Medicinal Products (OTC).
Dr. Doaa Rady is a highly experienced regulator who has dedicated her career to ensuring the quality, safety, and efficacy of biological products. With over 10 years of experience in the biological product sector, she has developed a deep understanding of the regulatory landscape and is widely recognized as an expert in her field.
She began her career as a lot release specialist at National Organization for Research and Control of Biologics, where she was responsible for release process for several biological products including vaccines and plasma derived medicinal products. During her tenure, she gained extensive experience in different regulatory functions.
Over the course of her time at the Egyptian regulatory authority, Doaa held several leadership positions, including serving as a team leader for the team establishing the risk-based lot release policy in Egypt, team leader for lot release team achieving WHO ML3 for LR function during benchmark of EDA, Egypt, and deputy of lot release department manager. In these roles, she was responsible for overseeing the review of a wide range of biological products, as well as she has active participation in many working groups responsible for providing guidance to industry on regulatory requirements and best practices.
She has also been an active participant in several professional organizations, including the International society of Pharmacoeconomic & outcome research (ISPOR) and the African Medicine Quality Forum technical committee which is One of the key components of The African Medicines Regulatory Harmonization (AMRH) initiative.
She has served on various international committees and working groups at ISPOR including Health equity special interest group, clinical outcome special interest group, real world evidence interest group and biosimilars interest group.
She had the opportunity to provide her feedback and insights to different regulatory guidelines and papers including ICH- Q9 quality risk management guideline, ICH-Q14 analytical procedure development, WHO approach towards the development of a global regulatory framework for cell and gene therapy products, ISPOR report on mapping HTA agency approaches for biosimilars value assessment and Primer on health equity research in health economics and outcomes research an ISPOR report. Moreover, Doaa Rady serves as peer reviewer for value in health journal and has active participation in reviewing research manuscripts and abstracts.
Doaa Rady holds a Bachelor of pharmaceutical science from the Helwan University, Egypt, a Master of Science degree in Microbiology & Immunology from Cairo, Egypt and Pharmacoeconomic and Health Technology Assessment Diploma from Cairo university in cooperation with Bournemouth university in UK She is a recognized leader in the field of biological product regulatory authority and is highly respected by her colleagues and managers.
Dr. Boutarene El Khaldia Nabiha, Director of Technical Monitoring, Inspection and Vigilance.
Previously head of the technical monitoring unit at the national agency of pharmaceutical products. Head of the Registration Department, then Head of Department at the National Laboratory of pharmaceutical products.
Biological engineer with quality control and analysis option, analysis at the national laboratory for the control of pharmaceutical products since 2013, auditor for the validation of quality control laboratories since 2016, inspector in the joint Anpp/Ministry of Commerce brigades since 2021, Currently I hold the position of technical-regulatory deputy director at the registration department of the national pharmaceutical products agency since April 2023.
Vanessa currently leads the work on regulatory and policy reforms under the African Medicines Regulatory Harmonisation Programme at AUDA-NEPAD, primarily focusing on coordinating and facilitating the development and implementation of legislative frameworks that enable African Union member States to effectively and efficiently regulate medical products. She has over 12 years of experience in policy advocacy and communication as well in project and grants management in various sectors including health. She holds and Bachelor of Science Honours Degree in Sociology from the University of Zimbabwe, a Post Graduate Diploma in Public Health from the University of Pretoria and she is a certified PRINCE 2 project manager.
Ropafadzai Hove is a public health professional, with more than thirty years experience in medicines regulatory affairs and policy co-ordination at national, regional, and international levels.
As Chief Regulatory Officer at BoMRA, she provides technical and strategic direction to the Technical Teams in the regulation of medicines, medical devices, and cosmetics.
She chaired the Pharmaceutical Advisory Committee in the Southern African Development Community (SADC) resulting in the establishment of the SADC work sharing initiative for medicines regulators, ZaZiBoNa.
Ropah is a pharmacist, with a Masters of Science degree in Pharmaceutical Services and Medicines Control from Bradford University, United Kingdom.
Silverani Padayachee is the Senior Manager: Pharmaceutical Evaluation Management at SAHPRA and oversee five subunits of quality and bioequivalence of small molecules, registration of biological, complementary and veterinary medicines. Silverani holds a Masters in the area of Pharmaceutics with over 30 years experience as a pharmacist in various fields of pharmacy i.e. in academia; hospital; manufacturing, clinical trials; pharmacovigilance, retail; research and over fifteen years experience in pharmaceutical quality, regulation and control at the Regulator (MCC and SAHPRA). Silverani has been invited by WHO Prequalifications of Medicines Programme (WHO PQ) to assist with assessments of medicines.
Silverani has participated in various health collaboration initiatives relating to Health System Strengthening and have been invited to speak on behalf of these initiatives at International conferences such as ICDRA (International Conference of Drug Regulatory Authorities) organized by WHO and to also chair international harmonization meetings.
Silverani also holds a Masters in Education with specialization in Adult Education and believes that adult learners are experiential learners and the work environment is a key element in expanding the knowledge base of any field, all that is needed is to encourage and support people to share these learnings with others. Hence ongoing training or mentorship is key in ensuring that members of her team are capacitated to ensure current global review standards are maintained.
A Pharmacist with 33 years’ experience and 23 years’ experience as Pharmaceutical and Quality Assurance Analyst. She holds MSc. in Pharmaceutical and Quality Control (1999) from KNUST-Ghana and currently a PhD candidate in Public Health Administration and Policy. She is a Fellow of the West Africa Postgraduate College of Pharmacists (2018) as well as a Fellow Ghana Post Graduate College of Pharmacists (2016).
Sybil has been working with WAHO for the past 12 years as the Professional Officer in charge of Pharmaceuticals, and now the Ag. Principal Program Officer and Head of Public Health Division. She has expertise in policy and strategic plan development, medicines regulatory systems, quality control systems for laboratories, ensuring the accreditations of the national regulatory agencies and laboratories to international standards, building local pharmaceutical manufacturing capacities and establishing good manufacturing practices. She has coordinated the ECOWAS Regional Medicines Regulatory Harmonization process since 2014, trained and developed regional experts in the pharmaceutical sectors to strengthen the human resource for the work force, as well as led various initiatives to improve access to quality, safe and affordable medical products in the ECOWAS region. Has good working relationships with stakeholders and partners. Currently coordinating the ECOWAS COVID-19 vaccines Taskforce to ensure effective access of COVID-19 vaccines and other vaccines production in the region.
Abebe Alamneh Kassahun is a dedicated professional with a strong background in the field of medicine regulatory affairs. He holds a Bachelor’s degree in Pharmacy and a Master’s degree in Medicine Regulatory Affairs from Addis Ababa University.
Currently, Abebe serves as a Medicine Registration Expert at the Ethiopian Food and Drug Authority (EFDA), where he plays a crucial role in ensuring the safety, efficacy, and quality of pharmaceutical products in Ethiopia. With his expertise, he actively contributes to the regulatory processes involved in the registration and approval of medicines, ensuring compliance with national and international standards.
In addition to his role at EFDA, Abebe also holds the esteemed position of Vice Chairman at the East African Regulatory Affairs Professionals Association (EARAPA). As the Vice Chairman, he demonstrates exemplary leadership skills and actively participates in shaping the regulatory landscape within the East African region. Abebe collaborates with fellow professionals to develop harmonized regulatory frameworks, facilitate information exchange, and promote best practices in medicine regulation.
Samuel Asante-Boateng is a Ghanaian by birth and about 56 years of age. He is a professional pharmacist trained at the Kwame Nkrumah University of Science and Technology (KNUST) Ghana 30 years ago and has also done further studies in MSc Pharm. Technology at the University of Bradford in UK. He has taken certificate courses in leadership, management and administration at the Ghana Institute of management and Public Administration (GIMPA). He currently works with the FDA Ghana as the Head of the Drugs and Herbal medicine Registration Directorate. He has been working in regulation for the past 17years. Before joining the FDA, Samuel Asante-Boateng worked in the pharmaceutical industry in Ghana for 12years.
He is part of the team of assessors at the FDA Ghana for the past 14years and has also participated in a lot of foreign GMP inspections.
In support of the West Africa Medicine Regulation Harmonization (WA-MRH) project, Samuel has been working as the chairman of the Expert Working Group for Medical Product Dossier Evaluation and Registration (EWG-MPDER) involved in the Regional joint assessment procedure in the ECOWAS region since its commencement in the year 2017.
Amos is a pharmacist with over fifteen years of comprehensive domestic and international experience in drug regulation and policy formulation. Studied Pharmacy and Finance and is studying Master of Science in Pharmacy Administration and Policy Regulation.
Started his regulatory journey in 2006 working as an inspector of drugs at the ports of entry. Led South Western and Northern regions as a Regional Inspector of Drugs for over 10 years and briefly acted as head of enforcement. Thereafter coordinated the implementation of Good Distribution Practices and Good Pharmacy Practices for Pharmaceutical products.
Is a trainer and lead GMP inspector who has inspected over 160 pharmaceutical manufacturing facilities in Africa, Asia, Europe, and United States for compliance with Good Manufacturing Practices.
Currently working as a Senior Inspector of Drugs and NDA representative to the Allied Health Professionals Council. Have great interest in emerging trends in regulatory policy and how it affects access to medical technologies.
Eager to learn, grow and excel in regulatory policy and public health so as to contribute to team success through hard work, patriotism, attention to detail and excellent organizational skills.
Dr. Elvis Temfack works at Africa CDC as Senior Research officer, based in Ethiopia. His background training is in clinical medicine and public health with over 15 years’ experience in clinical research and comprehensive clinical case management. Prior to joining Africa CDC, he joined Epicentre of Médecins Sans Frontières in Paris, a World Health Organization (WHO) collaborating Centre for Research in Epidemiology and Response to Emerging Diseases, working in Malawi for three years as field principal investigator generating relevant clinical evidence to support Malawian ministry of Health change pf policy for HIV first-line treatment from Efavirenz to Dolutegravir-based therapy.
He is a member of the European Society of Microbiology and Infectious Diseases (ESCMID), the International Society of Human and Animal Mycology (ISHAM) and a contributor to the Mycology One World One Guideline working group, an initiative of the European Confederation of Medical Mycologist (ECMM), ISHAM and American Society of Microbiology initiative (ASM). He has co-authored many peer reviewed publications in high readership international journals and is associate editor in some international journals. He is also a member of many collaborative working groups, serving in scientific and advisory groups addressing research in human health.
He is a pharmacist by training and graduated with Masters of pharmacy in Pharmacoepidemiology and Pharmacovigilance from University of Nairobi and recently completed a fellowship program in Anti-Microbial Resistance (AMR) from the London School of Hygiene and Tropical Medicine.
He is a chief principal regulatory officer at the Pharmacy and Poisons Board, in the department of product safety, having worked with PPB for over ten years across several regulatory functions which include regulatory inspections, clinical trials, pharmacovigilance and post-marketing surveillance. He has special interest in drug utilization studies and medicines regulatory science.
Richard is a pharmacist with 26 years’ experience starting off his career in hospital pharmacy in the public sector. He has spent the last 19 years in the regulatory profession in various capacities. He is currently the Director-General at the Medicines Control Authority of Zimbabwe.
Rosemary Nkemdilim Onwualu is a Scientist, GMP inspector, Lead Quality Auditor certified, and a regulatory Inspector with over 10 years in pharmaceutical GMP inspections and twenty three years’ experience with National Agency for Food and Drug Administration and Control [NAFDAC] Nigeria. Saddled with the responsibility to regulate medicinal products and medical devices. Rosemary is an experienced leader in the conduct of QMS internal auditing, inspection readiness activities, SOP development, quality document management, training, and technical paper reviews. She is recognized for her expertise in implementing QMS principles across settings and systems, a member of the quality team of her NRA, an active member of the NAFDAC-WHO GBT Team and has presented as subject matters topics regarding quality policy, quality objects, and other related matters.
She is the Nigerian Deputy GBT national focal person, that derived and championed the coordination and supervision of the Nigeria NRA GBT Program for Regulatory Inspection and Clinical Trial Oversight functions respectively to the successful attainment of maturity level three [ML3].
She contributed to several initiatives in terms of development of policy, guidance documents for Good Regulatory Practice in Nigeria.
A resource person in system strengthening programs, capacity building, training including mentoring of other NRAs on GBT Program in Nigeria and the Cote divoire for the attainment of ML3.
She participated in the review of WHO Listed Authority (WLA) guidance document.
Folasade is a Chief Regulatory Officer, at the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria’s Medicine Regulatory Agency.
While Folasade’s primary role in NAFDAC is to implement Quality Management Systems in line with ISO 9001, ISO 17025:2017 and WHO Standards at the National Quality Control Laboratory. She works on the Technical Working Group of the NAFDAC Traceability Office, supporting the execution of the five-year roadmap for implementing pharmaceutical traceability in Nigeria.
Folasade also serves on the NAFDAC-WHO Global Benchmarking Team. This team was constituted in 2018 to drive implementation and institutionalization of WHO Global Benchmarking Requirements in Nigeria’s regulatory System. Folasade coordinates the Laboratory Testing Function on this project. In 2022, the team’s efforts led to Nigeria attaining the WHO GBT Maturity Level (ML) 3 i.e. status of a stable, well-functioning and integrated regulatory system
Folasade trained as a pharmacist, at the University of Lagos, Nigeria. She has a master’s in public health (MPH) from the University of Western Cape South Africa and a Master of Public Policy (MPP) from the University of Oxford, UK.
Dr. Ibrahim Mustafa
Vice President of the General Authority for the Economic Zone of the Suez Canal for Investment and Promotion Affairs Since his assumption in January 2023, he has been working to achieve several goals to improve the investment environment, develop infrastructure, and increase industrial and logistical investments, by focusing on sectoral and geographical promotion.
Prior to his position, he held several positions as follows: Dr. Ibrahim Mustafa, Executive Director of Tariq Company for Economic and Financial Consultations Consultant to the first economic partnership councils in an American company and former senior advisor to the Minister of Investment Consultant to a number of local and foreign companies in the field of investment and development and an expert in economics, investment and business development – former economics lecturer for MBA students at Canadian Memorial University..
Former Senior Adviser at the Ministry of Investment and former General Coordinator of the Economic Conference (Sharm) El-Sheikh in March 2015- and a former advisor at Price Water House and Allen & Overy..- Former founding partner of Masarat Consulting. 2016-2018 Member of the Board of Directors of Collins Insurance Brokerage Company Member of the Board of Directors of Our Advisory Member of the Young Businessmen Association
Holds
Bachelor of Economics and Political Science from Cairo University 1998 Master’s degree in political economy, Cairo University, 2010 Mini Master of Business Administration accredited by Cairo University 2012
PhD in political economy
Cairo University 2021
A visionary entrepreneur and an industry captain, Dr. Amit N. Thakker, has been a ground-breaking pioneer in the integration of private sector within the healthcare system in Africa. Dr Thakker actively supports governments, corporates, health organizations and development partners to foster effective public private partnership initiatives towards improved health outcomes.
He is the executive chairman of Africa Health Business, a health consultancy, advisory and investment firm that aims to improve access to quality affordable healthcare in Africa. He is also the president of Africa Healthcare Federation, chairperson of the Kenya Health Professionals Oversight Authority, and the former chairman of Kenya Healthcare Federation.
He has served as a director at LumiraDx, Seven Seas Technology, AMREF Flying Doctors. Action Aid and Ghanima Limited. As an active member of several institutions including international business group YPO Gold (Nairobi Chapter), Dr. Thakker also chairs the University of Nairobi Alumni Medical Chapter and serves as an advisor to Asia Africa Investing & Consulting Ltd, Coalition for Blood in Africa (CoBA) and Ministry of Health, Kenya.
Dr. Thakker founded Avenue Healthcare, a Kenyan based integrated private health service provider in 1995 which lead him to receive the “Best Male Entrepreneur of the Year” award by Rotary International in 1999. He also won the “Best CEO” award by Titans Global in the Business and Professional services category in 2017 and proudly received the Chairman’s Award for Kenya Medical Association in 2004.
With more than 20 years’ experience in the Pharmaceutical Industry, Dr. Feirouz strongly believes that working for a Healthcare provider, our mission is to improve people’s life. Our role is to bring innovative solutions to serving the communities and enhancing their quality of life.
During her journey she got the opportunity and the pleasure to experience different roles, under different scopes in different countries moving from pure manufacturing function to regulatory, to government affairs before taking the leadership and the ownership of the consumer Healthcare business in Tunisia, North Africa and very recently in Egypt.
More than 15 years’ experience in the Pharmaceutical Industry,
My career journey is diverse, and I had the pleasure to experience different roles in the pharmaceutical industry starting from Sales moving to Sales Force Effectiveness and then shifting to Regulatory, where I found my passion and kept progressing in my career development till reaching my current role as “Africa Science Affairs Head in Sanofi Consumer Healthcare” responsible for all the science functions (Regulatory – Medical – Quality & Pharmacovigilance) across Africa.
I hold a Doctorate in Pharmacy from the Faculty of Medicine, Pharmacy, and Dentistry (FMPO) and a Master’s degree in Health Facility and Program Management from the Faculty of Economics and Management Sciences (FASEG).
Additionally, I have received training in the evaluation of drug Marketing Authorization Applications (MAAs) and the digitization of the healthcare system. Throughout my career, I have been involved in the digitization of the healthcare system, particularly in the digitalization of patients’ medical records, care pathways, and healthcare services in Senegal. I have also worked on situational analysis and problem-solving related to the dispensing and misuse of codeine-containing medications.
Currently, I am working at ARP, where I am involved in the implementation of a drug serialization system. I am also engaged in market control and surveillance activities.
Dr. Mona Al Moussli pursued her pharmacy studies. Holder of a Bachelor degree from Dubai pharmacy college 2002 and MBA from Preston university, in 2018 she has received her International Regulatory Affairs master degree from KREMS university – Vienna. She is the first initiator of regulatory affairs course in the gulf region, working closely with Dubai pharmacy college.
A Co-founder and Managing Director of PRA Consultancy which is the First Pharma Consultancy in UAE and she is an astute professional with over 15 years of hands on experience in the Regulatory Affair field for pharmaceuticals, Retail Pharmacies and Hospital Pharmacies, Dr. Al Moussli have been entrusted with international brands across the GCC and Middle East. Together with her PRA team she continuously delivers high quality standards to meet the fast paced, high turn-over industry. Regulatory conferences and trainings are among the many other activities she manages and she is working on pushing the health care products Regulations in 2021 to new levels.
BSc in Pharmacy from Jordan University, 1991
MSc in drug analysis from Monastir University, Tunisia, 1998
PhD in Pharmaceutical sciences from University of Lille II, France, 2005. PhD thesis was awarded with distinction, and it was nominated for “State Prize” at the Pharmaceutical Academy in Paris.
I have been working in the pharmaceutical industry for around 30 years. Joined Hikma Pharmaceuticals in 1991 and worked in different technical departments, with many years of hands-on experience in the formulation and process development, as well as analytical development of oral and injectable generic products. I held the position of Technical Director in Medicef (a newly established sister company for Hikma in Tunisia) for seven years, where I established all the technical departments: QA, QC, Product Pipeline, technical transfer and Regulatory Affairs. I also headed the Research and Development – Injectables department in Amman for around 10 years and successfully developed and registered new generic products targeting global markets in USA, EU and MENA.
Currently, I am heading the Regulatory Affairs activities in the MENA region, contributing to the development of the Regulatory strategy as well as setting the required implementation plans and programs that ensure effective and efficient function’s performance to best serve business needs across the region; while overseeing the Regulatory Affairs operations considering compliance with the internal and external policies and legislations, including submissions of new products in the pipeline and the maintenance of the existing portfolio in more than 14 countries in the MENA region, with local regulatory affairs teams in the majority of these countries. Work closely with health authorities and work on shaping the regulatory environment through liaising with the local agencies, local pharmaceutical organizations and associations and other stakeholders.
Other Activities in the Educational Field:
Jordan University of Science and Technology-Deanship of Scientific Research:
Yarmouk University:
Jordan University of Science and Technology (JUST) & Yarmouk University:
Jordanian Association for Pharmacists:
Received an appreciation and recognition award from the “Jordanian Association for Pharmacists” for the significant contribution to the development of pharmaceutical industry in Jordan (March 2019).
Hala Abu Ghazalah, Head of Regulatory Sciences, Africa & Middle East, Pfizer
Hala has over 25 years of experience in Pharmaceutical and Healthcare industries and had several leadership roles within Regulatory Affairs, External affairs, and Marketing
Pharmacist by education, licensed in both UAE and Canada
Dr. Sahar Ebrahim is a seasoned Public Health Physician with over 28 years of experience in the biopharmaceutical industry. She obtained her medical degree from Alexandria University and has since dedicated her career to clinical research. Currently serving as the Regional Head of Clinical Operations for the MENA region, Sahar is based in Egypt.
For the past 17 years, Dr. Sahar has been an invaluable member of Quintiles/IQVIA, where she has made significant contributions to the field. Her expertise extends across various regions, including Egypt, Levant, Gulf countries, and North Africa. As a certified Good Clinical Practice (GCP) trainer, Sahar has trained numerous professionals in the industry.
Throughout her career, Dr. Sahar has been involved in over 750 clinical trials, spanning phases I to IV, and has successfully recruited more than 55,000 subjects across 250 sites. She has collaborated closely with regulatory agencies in Arabic-speaking Middle Eastern and North African countries, conducting landscape assessments and benchmarking against more mature markets. Sahar has also organized regulatory workshops to share best practices and develop transformation roadmaps.
With an impressive track record, Sahar has conducted 80 site audits, 12 system audits, and 18 regulatory inspections. Additionally, she has played a pivotal role in streamlining business processes through strategic partnerships. Sahar’s contributions have been instrumental in supporting the expansion of a Prime and partner sites Network in the Middle East.
With her wealth of experience and deep understanding of the biopharmaceutical industry, Dr. Sahar Ebrahim continues to make significant strides in advancing clinical research and healthcare outcomes across the MENA region.
Konstantin has more than 15 years’ experience in IT products and implementation of complex B2B solutions for large and medium-sized companies. Six years ago, he set up Utrace, with the aspiration of making the complex and expensive process of compliance smooth and efficient by providing scalable, user-friendly and cost-effective solutions with high levels of automation. Now, six years later, Konstantin is proud to say Utrace has helped over 50 companies in the pharma and FMCG industries successfully comply with a host of complex requirements.
Arif is the Director of Business Development at Utrace and expert in Track & Trace management, IT project management, Supply chain processes organization and post-implementation technical support. Since 2011, Arif has participated in various implementation projects in large logistics, pharmaceutical and FMCG organizations. Arif is an evangelist of Track&Trace Technologies and has conducted dozens of webinars and consultations on building serialization processes in production and logistics functions.
His primary role is to achieve the milestones set to meet the strategic vision and direction of the organisation. He has 18 years of expertise in anti-counterfeit packaging technology, global pharmaceutical Serialization, Supply chain traceability, Product Authentication and Quality Control for the pharmaceutical industry and strives to develop better technological practices in the sector. His mission is to enhance productivity and quality, ultimately providing end consumers and patients with better outcomes. His vision is for ACG to lead in the technology and solution space for the pharmaceutical industry beyond regulation, setting new benchmarks to make it better.
With over 17 years of diverse experience in the clinical trial field, Ms. Bicky currently works as a freelancer, serving as the Director at a CRO named AfriLeadTech Research (PTY) LTD and holding the position of Chairperson at The South African Clinical Research Association (SACRA). Ms. Bicky is driven by a passion for growth and excellence within the clinical research industry. Her journey has encompassed various leadership roles, including Project Operations Director, Local Clinical Trial Manager, and Regional Study Manager across Africa, Asia, and Europe.
A Results-Driven Project Manager:
Ms. Bicky excels in overseeing and managing project operations both locally and globally. As the Project Operations Director, she led a team of dedicated Project Managers and successfully delivered high-priority services to valued clients.
Seasoned Clinical Trial Regulatory Expert:
Ms. Bicky’s expertise lies in regulatory matters; her entry into the clinical research field began with SAHPRA when it was called MCC. Specializing in streamlining regulatory processes and timelines, she ensures a seamless and efficient journey. With a keen eye for detail, she manages intricate regulatory requirements, documentation, and communication with authorities. Leveraging her strategic insight and extensive expertise, she accelerates the initiation and progress of clinical trials in South Africa.
Training, Quality, and Compliance:
Ms. Bicky takes pride in crafting comprehensive SOPs and training programs for CROs and Research Sites. Notably, she developed a 6-month CRA Training Program and Accredited GCP material.
Driving Ethical Research Practices:
With a profound understanding of ethical guidelines, including GCP and the Declaration of Helsinki, Ms. Bicky collaborates with ethics committees and IRBs to ensure ethical conduct in clinical research. Currently, she leads the SACRA input to the ICH GCP R3.
SACRA Chairperson | Strategist and Ethical Advocate | Entrepreneur:
As the SACRA Chairperson, Ms. Bicky advocates for clinical trials and mentorship programs, consistently sharing knowledge and staying updated about the latest changes in the clinical trial landscape. Leading the SACRA international clinical trials day for the past three years stands out as a career highlight. Functioning as a strategist, enthusiast, and entrepreneur in clinical research, she founded a flourishing clinical research site that contributes significantly to capacity building in South Africa.
Neveen holds degree of Bachelor of Pharmacy – Faculty of Pharmacy – Cairo University. She is currently Head of Regulatory Affairs North Africa, Egypt & Africa Developing Markets at Merck, supporting regulatory policy advocacy efforts for the region. She has over 20 years of experience in industry and 16 years of them as Regulatory Affairs, Prior to Regulatory Affairs she worked in several Multinational companies in different roles Commercial, Quality, Pharmacovigilance, Market Access & pricing. Neveen is also an active member of several trade associations including IFPMA Africa Regulatory Network (ARN); PhRMA Egypt Regulatory working Group; She participated in writing the Position paper for Registration Sampling & QC testing (IFPMA ARN)
He graduated from the Faculty of Pharmacy in 2008, then he joined the marketing, sales and Business administration diploma at the American University in Cairo and the Naval Academy as well.
He started his career in the Egyptian Drug Authority (formerly the Ministry of Health and Population) in 2013 and worked gradually until he reached the Head of Digital Transformation in EDA.
His big focus was managing the track and trace project in Egypt from 2018 until 2020 adding to that he managed to transform the registration to be automatically and having company profile for each entity registering in EDA then he decided to move to GS1 Egypt, where he is responsible for helping in implementing the GS1 standards in the healthcare sector and continuing to manage track and trace and other projects such as the UDI project for medical supplies, which was implemented in Egypt in 2021-2022 and other projects related to the health care sector in Egypt.
She has over 10 years of experience in Regulatory Affairs and Government Affairs. She has worked at GSK as the Regulatory Affairs Director for FWCA, OWA and East Africa region. She is well versed with the Africa Regulatory environment and has wide array of achievements in product registrations, divestments, license maintenance, renewals, artwork, labelling, government affairs and strategic planning to support business objectives.
She has a strong skill set in advocacy, legislation, government affairs and is currently the Chairperson of the Kenya Association of Pharmaceutical Industry (KAPI). She has led the industry association in advancing regulations, advocacy, and stakeholder engagements to positively shape the pharmaceutical Industry within East Africa. She is also a council member of Africa Engagement Committee, committee member of the Africa Regulatory Network and Regulatory Science Committee in IFPMA.
With more than +5 years of a demonstrated history of working in bio-Pharmaceutical and Pharmaceutical industry holding a bachelor degree of Pharmacy from Future University in Egypt, started my career in the academic field as a teaching assistant at Faculty of Pharmacy, Future University in Egypt, moved to regulatory affairs field in Biological Registration General Directorate in the Egyptian Health Authority., then Joined Amgen As Sr. Regulatory associate for Egypt & Iran and got promoted to Regulatory Affairs Manager for Eli countries.
At present, Ms. Mariham Gergis holds the position of the designated sub-team lead for life cycle management at EMEA Regulatory Management Center, where her scope of responsibility extends to the non-EEA region. She brings to the table a valuable nine-year span of local and regional regulatory experience.
Ms. Gergis embarked on her regulatory journey in December 2014 at MSD Egypt, assuming the role of Middle East labeling specialist. Through her tenure at MSD, she traversed through multiple roles, encompassing both labeling and regulatory capacities at the local level. Her oversight extended to pivotal areas like oncology and diabetes franchises.
In March 2020, Ms. Gergis transitioned to Janssen, the pharmaceutical entity under Johnson & Johnson, ushering in a new phase of regional engagement. Within the EMEA Regulatory Management Center, she assumed the mantle of Life Cycle Management, catering to the regulatory needs of the Jordan Egypt North Africa cluster /GCC, alongside the Kenya Nigeria Ghana clusters. Her journey within the organization culminated in a well-deserved promotion to her existing role.
Dr. Manal El-Sayed (Cairo, Egypt) is Professor of Pediatrics, Chair of the Pediatric department and director of the Clinical Research Center (MASRI-CRC) at the Faculty of Medicine, Ain Shams University.
Dr El-Sayed is a founding member of the Egyptian National Committee for Control of Viral Hepatitis (NCCVH) since 2006. She contributed to the establishment of a nationwide network of more than 120 specialized liver centers providing antiviral therapy for more than 3.5 million HCV-infected patients. Manal collaborated on the development of the national action plan for prevention and control of viral hepatitis published in 2014 with representatives from WHO, U.S. CDC, Pasteur Institute, and national stakeholders. In addition to co-supervising the nationwide mass screening program for adults and clinical director of the school screening program reaching so far more than >62 million people.
Manal is the secretary general of the Egyptian Liver Care Society, an NGO offering financial assistance to patients receiving hepatitis treatment or liver transplants as well as children with chronic viral hepatitis. She authored and co-authored numerous journal articles on hepatitis and participated in the development of the WHO’s global HBV, HCV and diagnostic guidelines. Between 2011-2015, Manal was Vice Chair of WHO’s technical advisory group for prevention and control of viral hepatitis in Egypt and is member of the Global Accelerator for Paediatric Formulations (GAP-f). She is governing board member of the International Coalition for Elimination of hepatitis B (ICE-HBV) since 2020 and among board of directors for the Hepatitis Fund (EndHep2030). In addition to co-organising and co-chairing
numerous international meetings on viral hepatitis and liver disease in Europe, US and Africa.
Professor El-Sayed co-founded and co-chairs the Conference on Liver Disease in Africa and is the President of the Society on Liver Disease in Africa (SOLDA). She received the Egyptian State Appreciation Award in advanced technological sciences that serve the fields of medical sciences in 2022.
Dr. Marielouise Abi Hanna, PharmD, boasts an impressive career spanning over 25 years, during which she led various roles within the pharmaceutical industry. Her expertise extends across Market Access, Global Regulatory Affairs, and Corporate functions, both at global and regional levels. Driven by a commitment to excellence, she has contributed to the success of major multinational corporations, including GlaxoSmithKline, Novartis, Sandoz, and Acino, covering Pharma, Biotech, and Generics.
In 2018, Dr. Abi Hanna embarked on a new venture, founding The Reg.Cloud, a specialized pharmaceutical consultancy. The Reg.Cloud provides invaluable services in Corporate Strategy, Due Diligences and Acquisitions, and is a trusted partner in driving Market Access throughout the product lifecycle.
With a global perspective, The Reg.Cloud empowers both emerging Small to Medium-sized Pharma Enterprises and established Multinationals to expand their reach, with a particular focus on markets spanning the Middle East, Africa, Asia Pacific, CIS, and Eastern Europe.
With over 18 years of experience in regulatory access and market intelligence healthcare industry, I successfully assisted different MAHs, manufactures and companies in developing innovative strategies for entering new markets, focusing on all different market access perspective such as BD, regulatory, pricing and vigilance considerations.
Through my career in different healthcare stakeholders of which Shocair Group (Arab Drugstore, Arab Medical and scientific Alliance and Amsterdam Medical and scientific Alliance )which I served for more than 15 years which id Shocair group, I successfully established and managed different operational departments such as supply chain, quality compliance, in addition to regulatory and intelligence department, which gave me enrichment exposure to registration experience in different regions and from different perspectives. Moreover, I was part of the teams responsible for revision of different JFDA regulations, member in drug owner association, in addition to my active participation as a keynote speaker at numerous healthcare industry events, I regularly provide updates on the latest trends in regulatory affairs. Additionally, I serve as a business coach and trainer, helping companies unlock the potential of their employees through technical training and personalized coaching.
As for my qualification; by educations I`m a pharmacist with two master degrees; Public Health and MBA which both supported my remarkable achievements in different scopes. Moreover, through continuous education and commitment to unremitting learning I gained different professional certifications in different regulatory access and market intelligence fields such as quality pharmacovigilance auditing (International Colleague of London), Professional GCC Regulatory Affairs Certificate (Dubai Pharmacy College), Certified Innovation Associate (GIMI), and Vocational Diploma in Regulatory Affairs of Pharmaceutical Products &Market Authorization (University of Jordan)
Recently, I`m working as a Regulatory Access and Market intelligence Strategist and Consultant through which I help companies to strategies their regulatory access in different countries with thorough market assessment. Support different MAHs in their regulatory projects within the region through creating innovative solution when coming to challenges faced with authority or other stakeholders. Furthermore, I create and implement effective business coaching plan for companies that positively reflected in their team achievements and increased quality of their work deliverables.
Dr. George Kamal is Regional regulatory Affairs Head for regulatory Hub based on Egypt and supporting regulatory operations for Middle East, Africa, Russia, CIS markets & Turkey in Merck Healthcare KGaA, Before Merck, Dr. George was leading international markets RA team in one of top leading pharmaceutical companies in Egypt.
Holding a bachelor’s degree in pharmaceutical science from Ain Shams university (2005) & Master of business administration from ESLSCS business school (2019).
Dr. George Has more than 17 years of experience within pharmaceutical industry in regulatory affairs and business development in different international markets.
Dr. Fatima Zaid Abu Zanat is an aspirational, committed, and experienced Regulatory Affairs/Quality Assurance (RA/ QA) professional with total of 17 years’ experience, with more than 12 RA/QA years in medical device, pharmaceutical and biotech industry across emerging markets with solid scientific background in product research/ development. Significant, strategic management exposure, where she is keen on developing optimum organization through performing periodical assessments, leading transformational changes, and developing best practices across the borders.
She was recently, professionally awarded the GCC Regulatory Affairs Award 2023 for the achievement “Woman of the Middle East” . She holds RAPS Dual Regulatory Affairs Diploma and Certificate (RAC Dual) in Medical Devices/Pharmaceuticals in addition to MSc in Pharmaceutical Technology. She is an active member in regulatory working groups within regulatory associations such as RAPS MENA local networking group as well as industry associations such as PhRMA MEA and formerly MECOMED. She is a licensed Basic Life Support Giver by American Heart Association and Licensed Specialist Pharmacist by UAE Ministry of Health and Jordan Food and Drug Administration.
She successfully established and managed multiple, UAE Scientific Offices for regional headquarters of emerging markets within Dubai, UAE; enabling organic/in-organic business growth. She built strong, direct channels with key, regional health authorities for continuous, shaping of the industry. She is experienced with development and management of teams on regional and global levels.
International publications:
Honors and awards:
Dr. Kurdi earned her PhD Degree in Biopharmaceutical Science in 2015 from University of Greenwich in UK.
Dr. Kurdi is currently working as Regulatory Affairs & Public Policy Director for EMEA Region at USP. USP is a non-Profit non-Governmental Organization with mission of assuring Quality of Medicines. Main responsibilities are to engage with USP Stakeholders, mainly National Regulatory Authorities, National Control Laboratories, International Organization like WHO, Pharmaceutical Association, Drug Policy Makers with topics and initiatives related to Heath and Quality.
Dr. Kurdi has over 30 years of experience in pharmaceutical industry in Quality Control, Quality Assurance, Research and Development, Regulatory Affairs, Commercial and Business Development including Technology Transfer (TT) as well licensing activities. Dr Kurdi held executive and management position during her work with Pharmaceutical Industry.
Additionally, Dr. Kurdi served as a member with more than committee with Jordanian FDA and international; With United State Pharmacopeia as an expert in the advisory panels of General Chapter (1197) and with International Generic and Biosimilar Medicine Association (IGBA) member in Biosimilar Committee.
Dr. Kurdi has many research papers published in Scientific Journals and she is frequent speaker in Pharmaceutical Conferences.
Kent Briggs is the Managing Director at VECTOR Life Sciences. He began working with eSubmissions in 2002 and eCTDs when they were first implemented in 2003. He has provided industry workshops in the US, Canada, Europe, South Africa, India and Australia and has performed application compilation training with both big and small pharmaceutical companies around the world. In addition to performing evaluator training at over 20 health authorities, Kent has authored the eCTD specifications for 4 regions including the soon to be released specifications for ECOWAS. Since 2014, Kent has focused on the CTD in Africa and supporting the harmonization efforts through regional and continental activities.
VECTOR Life Sciences is a service provider for the African regulatory market with a key focus on the implementation and usage of electronic systems to improve regulatory efficiency. VECTOR supports customers in their transition from paper based methods to electronic processes by streamlining their regulatory operations and making their use of data more effective
Marlene Moonsamy is the Head of Regulatory Affairs for the African cluster at Astra Zeneca since April 2023. Her career in the Pharma industry spans 15 years, with 13 of them being in Regulatory Affairs.
Her qualifications include Bachelor of Pharmacy and Master of Science in Medicine (Pharmacotherapy) degrees, from the University of the Witwatersrand in Johannesburg, South Africa.
Her regulatory affairs journey started with Novartis in 2010. She has since acquired considerable leadership experience and expertise across the African markets with Johnson & Johnson, GSK Consumer and Pharma divisions, and finally Abbott Laboratories, before joining Astra Zeneca.
She has led sustainable change, developed high performing teams, and engaged externally to influence the regulatory environment, while garnering awards and accolades along the way.
Susan Lin is a qualified pharmacist with a Bachelor of Pharmacy from Rhodes University with extensive experience in the healthcare industry.
Susan began her career in the public sector but later progressed to the Managed Care industry where she managed several portfolios. Her positions included the Executive Manager: Medicines Risk & Electronic Benefit Management and Senior Manager: Heath Policy Development.
Her interests have been focused on the development of strategies for enabling access to pharmaceuticals and medical technologies. She is a passionate advocate of sustainable solutions in promoting access to innovative medicines in South Africa.
Susan has recently joined PATH as the Senior Analyst: Public Health Advisor, where she provides advice on Africa’s health research and development, medical countermeasures manufacturing, regulatory harmonization, public health system, pandemic preparedness and health security to inform policy actions.
After graduating from Faculty of Pharmacy-Ain Shams university, Haidy started her career at Egyptian Drug authority then joined Novartis CH as Head of regulatory for North Africa and Near East where she lead the regulatory function for English and French speaking Africa as well as LEVANT, in 2015 and as part of the Joint venture between Novartis and GSK Haidy joined GSK Consumer Healthcare leading the function within the same geography and now she is Director of regulatory affairs North, East and West Africa .She has a diversified experience across Africa and Near East in regulatory , pharmacovigilance and regulatory compliance while combining corporate and governmental legislative experience.
Visionary leader bringing over 30 years of experience in RA field by establishing big product portfolio in Egypt and over 70 export Countries at Middle East and Gulf Countries, Africa, Europe, Asian and CIS Countries. Ensuring company products are on track with updated regulations
Successful achievements in registering the first two Egyptian Sterile Pharmaceutical Products at WHO Prequalification Program.
I consider each dossier as a case to be filed for a court, challenging the whole process till we won the case
I am a painter, and this gives me a touch of creative expression as problem solving and thinking outside the box with high attention to details
Dr. Mona Mousa has a bachelor’s degree of pharmaceutical Science from the
faculty of pharmacy Ain Shams University (2007).
She had been working in the Egyptian Drug Authority over the Past fourteen years,
Within managerial positions as head of Human Pharmaceuticals Regulatory and Technical Affairs
Administrations since 2019 till end of 2022.
Prior to that she had been working as a regulatory specialist in different departments at EDA,
Including Registration files review, Scientific and Technical Committee departments.
In addition to her experience as a pricing specialist and as an EDA Inspector.
Currently and since January 2023,
She is Regulatory Affairs Associate Director at Hikma – Egypt.
Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.
Inas has 20 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Regulatory and Policy departments for MEA region in Novartis.
Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.
Inas chaired EFPIA and PhRMA association groups for 6 consecutive years, and actively participating as speaker in regional and international conferences.
EDUCATION:
– B.Sc. of Pharmaceutical science – Alexandria University, 1988.
Joined Egypt Health Authority for 2 years after graduation as registration officer
Worked as regulatory officer for MUP (Egyptian pharmaceutical company –Egypt)
In 1992 Moved to multinational German company (Madaus / Rotta pharm/ Viatris pharma) as medical representative, then different function has been added to her responsibility as planning & production coordinator, Marketing, sales supervisor, till became Deputy General Manager
In 1999 Moved to Eli –Lilly working as Regulatory & Corporate affairs Manager and Quality for Egypt, Sudan & Libya
In 2013 joined the newly established research-based company AbbVie with enthusiasm to patient centric team
At the same time I am active with different pharmaceutical associations in Middle East, chairing RWG for pharma in Egypt for 10 years.
Support & coordinate pharmaceutical Industry & health authority to shape the regulatory environment in Egypt. Partnership with Health authority for capability building programs to support patients for better access & affordable medication.
Active Member of organizing committee of MERC 2015 & 2017, 2019, 2020 (virtual) and 2023.
She graduated in the Faculty of Pharmacy Cairo University then started her career in the academic field as a teaching assistant up to senior supervisor in pharmaceutical technology department, Faculty of Pharmacy, Misr International University (MIU).
After that she moved to the regulatory affairs field where she joined the Registration General Directorate in the Central Administration for Pharmaceutical Affairs (CAPA), Ministry of Health and Population of Egypt. she worked as the Rapporteur of The Technical Committee for Drug Control then she became the Head of Human Pharmaceutical Drug products Registration Directorate before moving to her current position.”
Regulatory Affairs expert with 14 years of solid Regulatory Affairs background in the pharmaceutical industry.
Profile and Areas of Expertise:
Experienced in developing different regulatory strategies in-line with business needs, leading registration, and lifecycle maintenance plans. In addition to safety management, compliance, SOPs design and audit readiness. Managed different lifecycle stages of an organization (merger, integration, and spin-off).
Drive interactions with Health Authorities, influence regulatory reforms and shape the external regulatory environment and health care policies.
Aspired to drive processes enhancements (Lean Six Sigma green belt certified). Have led and been a team member of different successful cross-functional projects including but not limited to New Product Launches, CMC and Ancillary component management, Safety management and Digital transformation in pharmaceutical industry.
Respect and leverage human capital – Motivate, coach, mentor and lead talented professionals helping teams to reach high integrated performance.
Position: Africa Cluster Manager – GSK
Lead Regulatory team for defined markets in relevant Cluster within EM organization as well as providing operational support including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party Partners.
In my previous role within GSK Egypt, I served as Senior Regulatory Affairs manager, Planning and organizing the business goals, designing strategies to advance those goals. provide regular and constructive feedback, resolve problems and conflicts positively. Keep an eye on the regulatory environmental changes Develop effective and systemic approaches to regulatory intelligence, analyze relevant intelligence findings and communicate impact in an efficient format that facilitates awareness of business critical issues. I have a diversified experience across Pharma, Vaccine, Maintain governance and compliance, Internal control Frame work and business development.
I hold a bachelor’s degree of pharmaceutical science, a master’s degree of business administration in SMEs (Small and medium business enterprises) from the Arab Academy for Science, technology & Maritime transport.
Dr. Donia Fady is the RA Head at Takeda Pharmaceutical, Egypt
with 17+ years of experience in the pharmaceutical field, Donia has a proven track of record in regulatory strategic management utilizing strategic enterprise thinking and strong leadership skills. combining governmental and pharmaceutical companies’ experiences with strong Pharmacovigilance and QMS background.
Dr. Donia holds Bachelor’s degree of Pharmacy – Faculty of Pharmacy-Cairo university
Reham Alassily occupies the role of Associate Director Regulatory Affairs for Near East, Middle East & Africa at IQVIA heading the regional Regulatory Affairs Hub. Reham is armed with an extensive background of 15+ years in the field of regulatory affairs and has occupied several leading roles in key multinational companies managing wide range of portfolios (Biological, Pharmaceutical ,Consumer health and Medical devices). In her current role at IQVIA, She is supporting several companies across diverse geographics to achieve business growth via establishing solid regulatory strategies.
Mr. Sidibé is a renowned tireless champion of African-owned solutions and has been an outspoken advocate for local pharmaceutical production of medicines and other essential health commodities. He contributed to the efforts towards access to quality and safe medicines and vaccines and in fighting global inequities.
In April 2021, he was appointed African Union Special Envoy for AMA. Thanks to his high-level advocacy efforts, the treaty entered into force on 5 November, much more quickly than expected.
A former Minister of Health and Social Affairs for Mali (2019-2020), Sidibé has championed a people centered approach to health and development for over 40 years.
He served as Executive Director of UNAIDS, holding the rank of Under-Secretary-General of the United Nations (2009-2019). Prior to joining UNAIDS, Mr. Sidibé worked at UNICEF and for Terre des Hommes, where his passion for advancing global health and social justice began.
Under his leadership at UNAIDS, more than 25 million people started life saving HIV treatment.
In 2021 he was appointed a board member of The Global Commission on Drug Policy.
An economist by training, Michel Hamala Mr. Sidibé is the recipient of various African and global awards, including honorary doctorates from world’s leading universities.
Samuel Asante-Boateng is a Ghanaian by birth and about 56 years of age. He is a professional pharmacist trained at the Kwame Nkrumah University of Science and Technology (KNUST) Ghana 30 years ago and has also done further studies in MSc Pharm. Technology at the University of Bradford in UK. He has taken certificate courses in leadership, management and administration at the Ghana Institute of management and Public Administration (GIMPA). He currently works with the FDA Ghana as the Head of the Drugs and Herbal medicine Registration Directorate. He has been working in regulation for the past 17years. Before joining the FDA, Samuel Asante-Boateng worked in the pharmaceutical industry in Ghana for 12years.
He is part of the team of assessors at the FDA Ghana for the past 14years and has also participated in a lot of foreign GMP inspections.
In support of the West Africa Medicine Regulation Harmonization (WA-MRH) project, Samuel has been working as the chairman of the Expert Working Group for Medical Product Dossier Evaluation and Registration (EWG-MPDER) involved in the Regional joint assessment procedure in the ECOWAS region since its commencement in the year 2017.
Margareth Ndomondo-Sigonda, works for AUDA-NEPAD as the Head of Programme. She is responsible for providing technical lead and strategic oversight on health and pharmaceutical programs such as the African Medicines Regulatory Harmonization (AMRH) Initiative, the establishment of African Medicines Agency as a specialized agency of the African Union (AU), and promotion of local production of pharmaceuticals in Africa. She currently leads the regulatory workstream of the AU Partnerships for African Vaccines Manufacturing (PAVM) Framework.
She previously served as Chief Pharmacist and Registrar of Pharmacy Board of Tanzania (1998-2003) and as the first Director General of the Tanzania Food and Drugs Authority (2003-2010).
She holds a PhD in Pharmacology from the University of the Witwatersrand, Johannesburg, South Africa.
Dr Manal Younus is currently the head of Iraqi Pharmacovigilance Center based in MOH. Manal is a pharmacist with a Ph.D. in Clinical Pharmacy. Key achievements include the establishment and the expansion of the Iraqi pharmacovigilance system. Represent Iraq in the WHO international drug monitoring program (PIDM). She is an International Society of Pharmacovigilance (ISoP) Advisory Board member and represent ISoP in the Council of International Organizations of Medical Sciences (CIOMS). Manal is the vice president of the ISoP Middle East chapter, ISoP Pharmacovigilance Professional Qualification Framework SIG member and she had authored more than 30 articles in different drug safety related subjects. Finally, a member of the specialized committee for Antimicrobial Resistance of the International Academy of Public Health (IAPH).
In addition to his current title, he is also the founding Deputy Director, and, in these roles, he has led the strategic work and oversight of Africa CDC. He works closely with African Union Member States and partners to deliver on the mandate of Africa CDC of preventing and controlling diseases in Africa.
Ahmed has led the operations of Africa CDC during the COVID-19 pandemic, coordinating the planning, acquisition, and delivery of life-saving health products to African countries including test kits, personal protective materials, therapeutics, and vaccines. Formerly, he worked with the WHO at both the HQs and Regional Office for Africa, in combating NCDs & tobacco control.
Prior to that, Dr. Ahmed worked at country level in the Ministry of Health, Kenya, as Director for NCDs and then Head of the Office for International Health Relations. He has been at the forefront of advocacy and action to reform the health system in Africa including the need to establish an efficient & effective response mechanism for disease threats and health emergencies. He has over 25 years’ experience in public health and is an alumnus of the University of Nairobi in Kenya and the University of Bergen in Norway.
S/Directrice de l’Homologation des Médicaments et des Autres Produits Pharmaceutiques – AIRP
Membre de la Commission Nationale du Médicament et des autres Produits Pharmaceutiques (CNMPP) représentant l’AIRP
Membre du comité des experts pour l’évaluation technique des demandes d’homologation
Pharmacien inspecteur assermenté au sein de l’AIRP depuis Juin 2022
Experte en Affaires règlementaires avec plus de 15 ans d’expérience dans l’Industrie Pharmaceutique
Membre fondateur de l’ARAF (Association des Règlementaires de l’Afrique Francophone) créé en 2009
Ancien membre des GTT organisés par le LEEM.
Dr. Janet Byaruhanga is a qualified medical doctor and public health expert that obtained her postgraduate diploma in public health research from the University of Edinburgh and has over 14 years of experience in international development with special focus in human and social sectors. Served as health policy officer at the African Union Commission since 2007 where she provided technical leadership and oversight in development and delivery of key strategic continental policy frameworks, programmes and initiatives geared towards strengthening the continent’s healthcare delivery system, food security and nutrition, and promoting the social well-being and rights of women and children.
Dr. Byaruhanga since 1st September 2017 joined the African Union Development Agency- NEPAD as a Senior Programme Officer-Health. She is in charge of coordinating and facilitating development and implementation of policies on health and medical products and ensuring their alignment with industrial development; trade; science, technology and innovation polices in advancement of the African Union’s African Health Strategy and the Pharmaceutical Manufacturing Plan for Africa (PMPA).
She is a registered pharmacist with an MSc in Pharmaceutics (Bioavailability). After spending 22 years in the pharmaceutical industry in regulatory affairs, quality assurance and pharmacovigilance roles with companies such as Merck KGaA, Boehringer Ingelheim and Merck Sharp & Dohme, she joined the South African Medicines Regulator, SAHPRA, in June 2020 to head up the organisation’s Backlog Clearance Programme. When SAHPRA was established in 2018, it inherited approx. 16,000 in-process applications from its predecessor, the Medicine Control Council.
A dedicated Programme was set up to clear the application backlog and, to date, the backlog is 99% finalised due to the various initiatives piloted and implemented within the project.
Bio:
Career:
Florah is a pharmacist by profession currently heading the pharmacovigilance unit of South African Health Products Regulatory Authority (SAHPRA). She holds BPharm and master’s in pharmacy with specialisation in Pharmacovigilance & Pharmacoepidemiology. She joined SAHPRA in 2011 as Medicine Registration Officer in the Pharmaceutical & Analytical Directorate and later Head the Vigilance unit since October 2015 to date. She has experience in different pharmacy sectors, including medicines regulation, retail and hospital pharmacy. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.
She supports the National Immunisation Safety Expert Committee and member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group, aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.
She is the Head of Regulatory Compliance at the South African Health Products Regulatory Authority (SAHPRA). She’s a pharmacist with over 20 years of experience in various sectors of Pharmacy within South Africa from clinical, drug utilisation review, regulatory and policy making. Qualifications are B. Pharm, MSc in Pharmacy and MBA from the University of the Witwatersrand.
She manages the activities of market surveillance and control function of medicines and medical devices in terms of the Medicines and Related Substances Act, 101 of 1965. This includes control of import activities; market surveillance program for monitoring the quality of medical products throughout the supply chain prevention; detection of and response to substandard and falsified medical products; control of promotional, marketing and advertising activities.
Her duties also include managing activities relating to consumption and reporting consumption (manufacture, import, export, distribution, possession and use) of narcotics and psychotropic substances to UN’s International Narcotics Control Board (INCB) in terms of the Conventions requirements. This includes supervision of activities relating to licensing, medical and scientific cannabis and she also represents the organisation in this regard.
Additional roles includes leadership coaching: Wits MBA students and she’s an ad hoc external examiner and assessor of postgrad pharmaceutical education qualifications/programmes.
2006:Diplôme National en pharmacie
Faculté de Pharmacie de Monastir-Tunisie
2014:Diplôme National de Docteur en Pharmacie
Faculté de Pharmacie de Monastir. Tunisie
2017:Mastère Professionnel de Management de la qualité dans ledomaine de la Santé.
Faculté de Pharmacie de Monastir. Tunisie
2019-2020 : CEC Pharmaco-économie et Market Access :
Faculté de Pharmacie de Monastir. Tunisie
2021: Certificate: « Project management in Global health »
Certificate: « Leadership and management in health »
University of Washington-USA/Polygone Learning El Kram Tunisie
2022: Certificate: « Project Management in HIV »
University of Washington-USA/Polygone Learning El Kram Tunisie
EXPERIENCES PROFESSIONNELLES
2008-2013 : Officine Privée à la Marsa-Tunisie
Poste occupé : Pharmacien assistant
Missions :
2013-Présent :Direction de la Pharmacie et du Médicament : Ministère de la Santé-Tunisie
Poste occupé : Pharmacien Principal de la santé Publique et chef de service de l’enregistrement des produits pharmaceutiques locaux
Missions :
He graduated from Doctor of Pharmacy (MCPHS University, USA).
After graduating he worked as a clinical pharmacist, owned, and ran a pharmacy, co-founded a Silicon Valley healthcare technology company, and ran a preventive healthcare company. Dr. Lucas is a co-patent holder for a neuropathic pain product. He is a certified pharmacogenetics/ pharmacogenomics pharmacist, Certified Immunization pharmacist since 2009, Certified Medication Therapy Management, among other.
His professional passions are:
He serves as co-founder and Director at NewSpring Foundation that supports bright kids from Kibera. He is a Rotarian of the Rotary Club of Nairobi. His hobbies include Soccer Golf, Cycling, CrossFit and coaching his son soccer team.
External Medicine Dossier Assessor at Ethiopian Food and Drug Authority (EFDA) and
the Co-founder & Vice President of East Africa Regulatory Affairs Professionals Association (EARAPA). Mr. Nathan is also an assistant lecturer at the Addis Ababa University, School of Pharmacy, Department of Social Pharmacy and Pharmaceutics, Medicine Regulatory Affairs program.
He graduated from Clinical Pharmacy at the Addis Ababa University, and he’s currently finalizing his Master’s Degree in Medicine Regulatory Affairs.
I am an academician at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy.
Max Goldberg leads the global medical device reporting team for Worldwide Patient Safety at BMS. He holds a bachelors and master’s degree in engineering and has expertise in medical devices and combination products throughout the entire product lifecycle. Max has been involved in product development, risk management, manufacturing, and post market surveillance for medical devices, combination products, and biologics. He is involved in forming and implementing global combination product post market safety reporting regulation.
Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA)
I work as a Drug Registration Officer at the Tanzania Medicines and Medical Devices Authority (TMDA) where I am involved in the evaluation of medicinal products dossiers. Within TMDA, I have been the focal person for the SADC Medicines Regulatory Harmonization Programme (SADC MRH) for the past two years. Under the this Programme I have participated in many activities and initiatives to include co-chairing the SADC Variations Technical Working Group, and currently serving as a member to the current Technical Working Group (TWG) responsible for developing SADC Emergency Use Authorization Framework under the support of the German Federal Institute for Drugs and Medical Devices.
I am currently the Focal Person and the Regional Technical Officer for the East African Community Medicines Regulatory Harmonization Programme where I coordinate all matters related to EAC joint activities including assessment of dossiers and quality assurance of reports as well as a serving as a member of the Expert Working Group on Medicines Evaluation and Registration of the Programme.
She is an American board certified for pharmacotherapy specialty, she has two master degrees, one in clinical. pharmacotherapy and the second in public Administration from the American University in Cairo.
She is a fellow at the Egyptian board for healthcare management. She has profound working history in regulating pharmaceutical practices in the Egyptian public and private sectors, she used to be managing the PV General administration for more than 2 years, supporting the additionally, she represents the Egyptian drug authority as an Observer at the international cooperation on cosmetic regulations working group ICCR. Previously, she used to be the antimicrobial stewardship national coordinator and participated in the development of the National Action Plan for Antimicrobial Resistance.
Mr HONORE AYINKAMIYE is a Pharmacist with experience of more than 10 years in the pharmaceutical sector, both in private and public institutions, where he has been involved in technical and managerial positions. Currently, he is working with Rwanda Food and Drugs Authority (Rwanda FDA) as a Finished and Active Pharmaceutical Products Registration Specialist.
HONORE has been involved in different regulatory activities at the country level and he is also contributing to the Medicines Regulatory Harmonization initiatives as the assessor of product dossier applications at the East African Community (EAC) level to insure the products’ quality, safety and efficacy.
He is also the Focal Person for the WHO/SRA Collaborative Registration Procedures (CRP), a facilitated procedure that aims to accelerate the registration process through improved information sharing between WHO PQ and national regulatory authorities (NRAs).
HONORE is passionate about ensuring equitable access to safe, efficacious and quality health commodities.
Currently Executive Director of Zanzibar Food and Drug Agency (ZFDA). Over 20 years’ experience in strengthening Zanzibar Medicine Regulatory Authority from less resourced Pharmacy Board to the middle-income Food and Drug Agency.
He Participated in WHO assessment of Medicine Regulatory System in Sub Saharan African Countries, Devoted, Pioneering and Volunteering in Regional Medicine Regulatory Harmonization Initiatives and African Union Medicine, Policy and Regulation Reforms Expert Working Groups.
Dr. Peter Mbwiiri Ikamati is a Medicines Evaluation & Registration expert at Pharmacy and Poisons Board (PPB, Kenya) and EAC MRH programme (Assessment). He is the current Chief Principal Regulatory officer, Product Evaluation and Registration and has been overseeing all the PPB regulatory functions (on behalf of the Chief Executive Officer) towards achieving WHO Maturity Level 3 from May 2021. He has interest in research and has published work on analytical methods development and development of microspheric systems for drug delivery. Dr Mbwiiri additionally has interest in clinical trials regulations.
Dr. Mbwiiri earned his Bachelor of Pharmacy degree from the University of Nairobi in 2000. He holds a master’s degree in pharmaceutical sciences with Management Studies from the Kingston University in London and a doctorate in Health Sciences (Targeted drug delivery systems) from the Aston University, UK. He is an associate fellow of Higher Education (UK).
Dr. Mbwiiri started work at Ministry of Health as a Hospital Pharmacist and held various capacities upto the year 2005 when he joined the Pharmacy and Poisons Board (PPB; the National Medicines Regulatory Authority, Kenya). At Mbagathi district hospital, where he had risen to superintendent Pharmacist, he was part of the team that initiated piloting of HAART (Highly Active Anti-retroviral Therapy) programme that allowed for provision of antiretrovirals in public hospitals in Kenya.
Dr. Mbwiiri has a wealth of regulatory experience having served in various capacities within the Pharmacy and Poisons Board. He has been instrumental in initiating reforms on medicines evaluation and registration at the Pharmacy and Poisons Board (Kenya) and regionally (at East Africa Community (EAC) and Intergovernmental Authority on Development (IGAD).
Dr. Mbwiiri is also a consultant with World Health Organization Prequalification Team (formerly WHO Prequalification programme).
Farai joined the MCAZ in 2011 and has been involved in regulatory affairs for over 10 years.
He has been involved with the ZAZIBONA collaboration since its inception in 2013.
Farai has coordinated the ZAZIBONA dossier assessment activities since 2015.
A visionary entrepreneur and an industry captain, Dr. Amit N. Thakker, has been a ground-breaking pioneer in the integration of private sector within the healthcare system in Africa. Dr Thakker actively supports governments, corporates, health organizations and development partners to foster effective public private partnership initiatives towards improved health outcomes.
He is the executive chairman of Africa Health Business, a health consultancy, advisory and investment firm that aims to improve access to quality affordable healthcare in Africa. He is also the president of Africa Healthcare Federation, chairperson of the Kenya Health Professionals Oversight Authority, and the former chairman of Kenya Healthcare Federation.
He has served as a director at LumiraDx, Seven Seas Technology, AMREF Flying Doctors. Action Aid and Ghanima Limited. As an active member of several institutions including international business group YPO Gold (Nairobi Chapter), Dr. Thakker also chairs the University of Nairobi Alumni Medical Chapter and serves as an advisor to Asia Africa Investing & Consulting Ltd, Coalition for Blood in Africa (CoBA) and Ministry of Health, Kenya.
Dr. Thakker founded Avenue Healthcare, a Kenyan based integrated private health service provider in 1995 which lead him to receive the “Best Male Entrepreneur of the Year” award by Rotary International in 1999. He also won the “Best CEO” award by Titans Global in the Business and Professional services category in 2017 and proudly received the Chairman’s Award for Kenya Medical Association in 2004.
Lenias Hwenda is the Founder and CEO of Medicines for Africa, a social enterprise that improves access to treatment. She is a recognized influential thought leader and practitioner who continues to contribute at the highest stage of international health affairs working with African governments in the World Health Organization for more than a decade. She has participated in and led a number of intergovernmental and industry negotiations seeking the best solutions to meet the health needs of vulnerable people around the world. Lenias recently co-chaired the historic World Health Organization negotiations between governments on improving the transparency of markets for medicines, vaccines, and other health products during the World Health Assembly in 2019. She is a tireless advocate using her deep knowledge of public health, international affairs and health security to drive initiatives that improve access to healthcare by underserved communities. She hosts “Let´s Talk about health in Africa” Podcast conversations highlighting challenges and opportunities for improving the health of Africans.
Nevena Miletic is a Regulatory and Policy professional, passionate about bringing innovative therapeutic solutions to patients in need around the world.
She is a pharmacist, with postgraduate studies in Pharmacoeconomics, regulatory affairs and quality assurance, and a certified QP, with almost twenty years of experience in pharmaceutical industry.
Currently she works in the Global Regulatory Policy group in F. Hoffmann-La Roche, Switzerland, and for the last six years, she is chairing IFPMA Africa Regulatory Network and IFPMA CPP Network.
She is also a member of research-based pharmaceutical companies associations and boards (IFPMA Regulatory Science Committee, IFPMA Africa Engagement Committee, DIA Middle East & Africa Advisory Board, EFPIA ERAO, IATF etc.), involved in numerous meetings, workshops and projects with regulators, cross-industry and public-private collaborative platforms (e.g. Pre-ICDRA, ICDRA, SCoMRA, IMI/IHI etc.).
Ms. Miletic is strong advocate for regulatory convergence and harmonization, as well as for modernization of regulatory frameworks to enable innovative approaches in drug development and review.
She is a pharmacist by training. She has specialized in Pharmacoepidemiology and Pharmacovigilance, currently enrolled for PHD studies in Clinical Pharmacology and Pharmacovigilance at Karolinska Institutet in Sweden focusing on strengthening safety monitoring in public health programs with a focus on mass drug administration.
She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board, Kenya, and the Vice President of International Society of Pharmacovigilance, Africa Chapter. She has 15 years working experience in Pharmacovigilance related work and is responsible for leading the PV team in Kenya to develop regulatory systems to strength Pharmacovigilance within the health sector and pharmaceutical industry.
She is a member of the Pharmacovigilance and PMS technical working groups in Kenya, within the East African Community and The Intergovernmental Authority on Development Regional Economic Blocks and has contributed to development of various tools and guidelines for strengthening of PV in the region. Recently appointed as a member of the AMRH Technical Committee on Regulatory Capacity Development in Africa (ToR RCD)
She is passionate about patient safety and keen on strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medical products and health technologies, she is also keen in contributing to a pool of trained PV specialists in Kenya and gives honorary lecturers to both undergraduate and masters students at University of Nairobi.
My current title is EMEA RA Lifecycle manager at Janssen. I am handling lifecycle management activities for the Pharma portfolio for countries in the Non-European Economic area region (includes Africa).
I have 10 years of Regulatory experience in different Regional/Global roles from 4 different pharma companies like Pfizer, GSK, Amgen and Janssen. I keep it brief, but please let me know if you want more details.
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Pr Nadjat LOUMI-MEDEDJEL, Director of the Centre National de Pharmacovigilance et de Materiovigilance (CNPM), is a doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon (France).
She took part in the creation of the CNPM with its founder Professor A Helali in 1998, whereshe has always been devoted to pharmacovigilance and materiovigilance.
Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medicaldevice and the vaccine alreadyestablished.
Teacherat the Faculty of Medicine of Algiers, wheresheteaches the module of pharmacology. She supervises the training of resident physicians in clinical pharmacology.
She supervises also the training of health professional in :
“Pharmacovigilance and Materiovigilance” ; “Medical good prescribing” ; “Monitoring plasmatic of medicine” ; “Rational drug use program”.
She is Editor of the independent Medical journal “la Revue Prescrire” since 2007.
Kate Kikule is the Principal Technical Advisor for the pharmaceutical regulatory systems portfolio under the Medicines, Technologies and Pharmaceutical Services (MTaPS) initiative of the Medicines Sciences for Health (MSH), with expertise in regulation of medicines and health technologies. Kikule supports country programs by providing technical assistance to strengthen medicine regulatory functions, including medicine registration, regulatory inspections, licensing of premises, market surveillance, and pharmacovigilance. She also provides technical guidance for the development and implementation of policies, regulations, guidelines, and tools for strong and effective pharmaceutical regulatory systems. She is an experienced public health professional and pharmacist with more 20 years of experience in medicine regulation in emerging and low- and middle-income countries across Africa, Asia, and Europe. Kikule holds a Bachelor of Pharmacy (Hons) from the University of Dar-es- Salaam, United Republic of Tanzania, and an MPH specializing in health economics from the University of Capetown, South Africa.
George is a pharmacist by profession and had a Master degree in Public Health from the University of Ghana and a certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine. He is currently a PhD candidate at the University of Groningen where his thesis is focused on patients’ contribution to pharmacovigilance in Sub-Saharan Africa.
He is a Chief Regulatory Officer and the Head of the Safety Monitoring Department at the Food and Drugs Authority.
He has authored several abstracts and original research articles on medicine safety in peer reviewed journals.
George’s interest is in strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medicines and other health products.
Santosh Balbhadra Trivedi has a Bachelor of Engineering (Chemical) degree from G H Patel College of Engineering and Technology, Vallabh Vidyanagar, Gujarat, India, where he studied from 1998 to 2002. He has almost 20 years of overall experience and has worked in the Pharma & Life Sciences industry vertical for over 12 years in various roles from a Developer to Business Analyst, Product Owner, Serialization and Track & Trace expert, etc.
His current role since Feb-2022 is with Honeywell as the Senior Product Manager – Track & Trace facilitating governments/customers implementing Serialization and Track & Trace solutions to adhere to/implement the legal regulation requirements and/or to implement the value added solutions to improvise the supply chain visibility and integrity.
Brève présentation : Pharmacien, marié et père de trois enfants. J’ai treize (15) ans d’expérience professionnelle dont dix (10) ans dans le domaine de la réglementation et de la régulation pharmaceutique. Je suis dans l’amélioration continue du travail et j’ai une bonne capacité d’adaptation. Mes objectifs professionnels : Acquerir une excellente compétence dans la régulation pharmaceutique et Partager ces connaissances acquises en tant qu’expert.
Ashifi founded Sproxil® in 2009 and currently serves as the company’s Chief Executive Officer. Under his leadership, Sproxil developed its award-winning solutions that have been used on over 2.5 billion product units available to consumers in 6 countries to verify the authenticity of their products and earn instant rewards for their loyalty.
In 2015, Ashifi was named to Fortune’s 40 under 40 list. He was awarded the Social Entrepreneur of the Year award in 2014 by the Schwab Foundation and joined the Fast Company Most Creative People in Business 1000 community. In 2013, Sproxil was named the world’s most innovative company in health care by Fast Company, and #7 most innovative worldwide, beating 99 of the Fortune 100 companies. Most recently, he has been picked as a finalist for the 2020 Global Business Hall of Fame presented by JA Worldwide.
Ashifi served on the World Economic Forum’s Global Agenda Council on Social Innovation and on the Meta-Council on the Illicit Economy. He holds a US Patent and earned a Ph.D. in Engineering from Dartmouth College, where he delivered the 2020 alumni remarks at Investiture. Ashifi holds a B.A. in Mathematics and Physics from Whitman College. He was Whitman’s 2018 commencement speaker and received an honorary doctorate. He is Dartmouth’s first-ever Ph.D. Innovation Fellow and teaches an executive seminar and a course in New Business Ventures Technology Management at Columbia University.
Ashifi volunteers for the Whitman College President’s Advisory Board and the Board of Advisors at Dartmouth’s Thayer School of Engineering.
Dr. Amira Amin received her Bachelor degree of pharmaceutical science. faculty of pharmacy, Cairo University in 2006 and Diploma in clinical pharmacy from faculty of pharmacy (Ain-Shams university) in 2010.
Today she is the deputy head of Egyptian pharmaceutical vigilance administration at Egyptian Drug Authority since September 2020 and joined from pharmacovigilance specialist at Egyptian pharmacovigilance center (EPVC) – (CAPA) – Ministry of health (MOH) where she honed her skills for 6 years.
Tshepiso has assumed a role of a Clinical Operations Manager within one of the rapidly growing CRO organizations, Tigermed. She has prior experience as Head of Clinical Monitoring at one of the leading pharmaceutical companies, GSK.
Previously gained experience as a Local Study Manager, CRA, Study Coordinator.
In her recent clinical research journey and different roles, she gained experience in providing leadership, cultivating good relationships with internal and external stakeholders. Tshepiso is committed in delivering what is expected of her with integrity: by being dependable, accountable, with primary focus on doing what is right and of high quality.
Greg Perry joined IFPMA on 1st February 2018 and has responsibility for IFPMA’s external outreach and stakeholder engagement in global health topics including innovation, access, and the international regulatory environment. Greg Perry brought with him more than 20 years’ leadership and advocacy experience in the public healthcare arena.
Prior to joining IFPMA, Greg worked as Executive Director of the Medicines Patent Pool, which he joined in 2013 and as Director General of the European Generic Medicines Association (1999 – 2013) in Brussels. Previously he worked as a partner in a UK public affairs company as a European Union policy advisor to corporate and non-governmental organizations, and before that as a Parliamentary Advisor to Members of the European Parliament. Greg is a Member of the Advisory Council of the Organization for Professionals in Regulatory Affairs (TOPRA) and is a former member of the Standing Advisory Committee before the European Patent Office (SACEPO). Greg also holds the Golden Cross of Merit of the Republic of Poland.
Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University. Inas has 18 years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Regulatory and Policy departments for MEA region in Novartis.
Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.
Inas chaired the EFPIA regulatory group for 3 years; And she chaired the PhRMA association regulatory group for 4 years. She also chaired the program committee for the Middle East regulatory conference in 2019, and actively participating as a speaker in regional and international conferences.
He has more than 7 years of consulting experience within a variety of industries including, Financial Services, Energy and Resources and Life Sciences and Health Care. Prior to joining Deloitte, Mitesh gained 4 years of clinical experience as a Physiotherapist. His recent focus areas have been Data Strategy, Data Management, Data Privacy and Insights Driven Organisation.
Sisay Endale Biru is an academician and researcher at Addis Ababa University, College of Health Sciences, School of Pharmacy, Ethiopia. He completed his Bachelor of Pharmacy from Addis Ababa University and Master of Sciences in Regulatory Affairs (Medicine Regulation Track) from the same university.
He also graduated from Admas University with a bachelor’s degree in Marketing Management. He is currently engaged in research, teaching, and advising. He is the coordinator of Pharmacovigilance (PV) at the Tikur Anbessa Specialized Hospital’s PV center in Addis Ababa, Ethiopia. He works with the Ethiopian Pharmaceutical Association as a trainer, PV course lead, and CPD course evaluator.
Additionally, he actively contributes to the development of policy, research, the development of PV training materials, and the assessment of medication dossiers for the Ethiopian Food and Drug Authority (EFDA). His research interests include health and drug policy analysis, drug regulation, and drug safety (PV).
Patricia is a Pharm D. Grad. from ‘Saint Joseph University’, Beirut, Lebanon with 20 years of experience in the corporate pharma world (Novartis, Wyeth, Pfizer, Merck), mainly in the regulatory affairs arena.
She is currently heading the regulatory affairs of the healthcare business of Merck in the MEAR region: Middle East, Africa, Turkey, Russia & CIS countries; handling a wide & diverse team of RA professionals who are well engaged and acting as external pioneers in the industry via various trade associations i.e., IFPMA-ARN, IPASA, PhRMA, EFPIA: MERN, Russia-CIS & Turkey.
Since the beginning of her RA Career, Patricia was keen on enabling access of medicines and therapeutic solutions to patients around the world. Hence, she has been a highly active member in the industry via IFPMA/EFPIA/PhRMA associations and have contributed to multiple key events like pre-ICDRA, ICRDA, DIA MERC, Access to Innovation Webinars amongst many others, partnering with multiple Authorities in the MEA region.
Since March 2021, Patricia has been acting as the Chair of the PhRMA MEA RA Group; enabling, with the support of her seasoned esteemed peers, the design and implementation of multiple capabilities’ building programs for key Authorities in the MEA region like KSA, Algeria, Egypt & South Africa, which have been translated into enhanced and re-shaped policies & regulations.
Patricia’s belief is in passion to make great things happen with her motto being: “Regulate for a brighter future. Partner for earlier & better access”.
