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.

Nuran Idris joined GS1 Global Office in January 2020. She works in the Healthcare team as Healthcare manager for Africa. She is based in Nairobi, Kenya and is originally from neighboring Tanzania.

Nuran’s main role at GS1 is to support countries in Africa in establishing pharmaceutical traceability systems using GS1 standards.

Prior to joining GS1, she worked for multiple USAID funded projects in Tanzania and Malawi with short term engagements in Zambia and Ivory Coast. Nuran also briefly worked for one of Global Fund’s project in The Netherlands.

Nuran’s experiences have seen her engage multiple stakeholders from the grass root level up to senior levels in local and international settings. From the digital health angle, Nuran has conducted trainings and managed teams that deployed systems that have contributed positively to improvements in local supply chain operations.

With the power of standards, Nuran strongly believes that even more efficiencies and mostly, improved care to patients can be achieved in developing countries.

Nuran is a Political Scientist and a global eHealth specialist by training.

John currently works at Bayer as Head of Regulatory Affairs responsible for East & West Central Africa Region based in Kenya, responsible for Pharmaceuticals and Consumer Health divisions and doubling up as Regulatory Policy & Intelligence Lead for EEMEA Region.  He has previously held different roles in Pharmacovigilance and Quality Control within the Pharmaceutical Industry. He has been an active member of several industry associations including KAPI (Kenya Association of Pharmaceutical Industry) where he has served as member since 2013 including as past executive secretary and continues to serve in in various committees within KAPI and as Board Member.

John is passionate about supporting the streamline of Pharmaceutical Regulatory Systems & Policy and is currently a member of the Africa Regulatory Network (ARN) within the IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) where he is the immediate past co-chair. Additionally, John represents Bayer in the Africa Engagement Committee of the IFPMA and is currently a member of the Africa Strategy for the Global Self Care Federation (GSCF).

She is responsible for leading and providing strategic direction and oversight to the Country’s regulatory teams, thus ensuring the development and execution of regulatory strategies and plans to meet business objectives.

Bunmi has over 30 years of experience in the pharmaceutical industry in Sales & mostly Regulatory Affairs (RA). She is a principled individual, passionate about integrity and business ethics, and a spirited team player.

She joined Pfizer in 1992 as a Medical Sales Representative and was appointed Regulatory Affairs Manager for Ghana and Nigeria in 1999.

In 2005, she was appointed as an Associate Director, Regulatory, Safety, and Quality to cover East, West, and Central Africa and her responsibilities have since increased.

She is a member of the IFPMA African Regulatory Network. She sits on various committees for the development of Regulatory Policies and Guidelines to support regulatory systems strengthening in partnership with local trade associations and other stakeholders.

Bunmi holds a bachelor’s degree in Pharmacy and an MBA from Obafemi Awolowo University, Ile-Ife, Nigeria.

She is passionate about developing people, building effective teams, and conflict management.a

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.

Dr. Aliou NDIAYE, esteemed pharmacist and specialized in the digitalization of the healthcare system and the development of digital health solutions, is a distinguished leader in the field of health innovation and the development of AI-based medical technology.

Dr. Aliou holds three degrees from UCAD: a Doctorate in Pharmacy from the Faculty of Medicine, Pharmacy, and Dentistry (FMPO), a Master’s in Health Facilities and Programs Management from the Faculty of Economics and Management (FASEG), and a Master’s in Project Management from the School of Applied Economics (ESEA).

He is also certified in agile project management with SCRUM, and implementation research. Additionally, he has training in evaluating drug marketing authorization (MA) application dossiers and clinical trial implementation requests.

Throughout his career, Dr. Aliou has worked on the digitalization of the healthcare system, particularly focusing on digitizing patients’ medical records, care pathways, and health services in Senegal. He has also been involved in situational analysis and addressing issues related to the dispensing and misuse of medications containing codeine.

Currently, he is serving at the Senegalese pharmaceutical Regulatory Agency (ARP), where he is working on implementing a drug serialization system.

Dr. Safa’ has more than 30 years of experience in research and development, quality and regulatory affairs within the pharmaceutical industry and held several leadership positions in Jordan and Tunisia. She has wide experience in developing and registering new generic products targeting global markets in the USA, Europe and MENA.

Dr. Safa’ is currently heading the Regulatory Affairs activities in the MENA region in Hikma Pharmaceuticals. She is responsible for the development of the regulatory strategies and setting the required implementation plans across more than 16 countries in the region. She works closely with health authorities to help in shaping the regulatory environment in the region.

Dr. Safa’ has:

BSc in Pharmacy from University of Jordan

MSc in Drug Analysis from Monastir University, Tunisia

PhD in Pharmaceutical Sciences from University of Lille, France

Dr. Safa’ is an active member of the Jordanian Association for Pharmacists JAP – Registration Committee. She delivers lectures in different Jordanian universities on regulatory affairs and other pharmaceutical industry topics. In 2019, she received an appreciation and recognition award from the association for her significant contribution to the development of the pharmaceutical industry in Jordan.

She is also an active member in the scientific committee of the AUPAM (Arab Union for Pharmaceutical Manufactures) and the scientific committee of the Charity Medicine Bank in Jordan.

Dr. Hala has over 25 years of experience in Pharmaceutical and Healthcare industries and had several leadership roles within Regulatory Affairs, External Affairs, and Marketing.

She is a pharmacist by education, licensed both in the UAE and Canada.

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 organisations 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, a member of the Ethical Principles in Health Care (EPiHC) advisory board, he is a fellow of The Academy of Public Health (APH), and the former chairman of Kenya Healthcare Federation. He has served as a director at LumiraDx, Seven Seas Technology, AMREF Flying Doctors Action Aid, East African Health Platform and East African Business Council.

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/Director to AAIC Investment PTE. Ltd, Coalition for Blood in Africa (CoBA), United Asian Network (UAN), Ghanima Ltd, KEPSA (Kenya Private Sector Alliance) 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 Entreprenuer of the Year” award by Rotary International in 1999. He has served as the CEO for Amini Management Ltd, Africa Medical Investments plc, Momentum Kenya leading him to win “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.

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)

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. 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:

• RAPS E-BOOK: F.Z. ABU– ZANAT(2022). Section IV postauthorization commitments and studies: Chapter 18 Middle East and North Africa. In L.M. and P.T (Ed.). Postapproval Changes for Drugs: A Practical Guide (pp. 209 – 212). RAPS.
• RP– LC Analysis Article: F.Z. ABU– ZANAT(2012). Ibuprofen Determination in Aqueous Solutions and Biological Samples. MedLab Magazine, 2012 (1): 36 – 42.
• Research Article: F.Z. ABU– ZANAT et al(2011). A Promising Codrug of Nicotinic Acid and Ibuprofen for Managing Dyslipidemia. I: Synthesis and In Vitro Evaluation. Drug Development and Industrial Pharmacy, 37 (9): 1090 – 1099.

Honors and awards:

• GCC Regulatory Affairs Award – 2023: For the achievement “Woman of the Middle East”.
• Women of Ipsen Nomination – 2022: One of 68 nominated Women of Ipsen for 2022 and the only one from META region.
• DUPHAT 2012 – 3rd Best Professional Poster Award: Professional Poster and Oral Presentation entitled “Synthesis and Evaluation of Nicotinic Acid and Ibuprofen Codrug for Managing Dyslipidemia by Newly Developed and Validated HPLC Method”, based on MSc Pharmaceutical Technology thesis dissertation.

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.

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.

Mr. Abebe Alamneh, esteemed regulatory affairs professional at East Africa Regulatory Affairs professionals Association (EARAPA) and Ethiopia Food and Drug authority (EFDA) , is a distinguished leader in the field of pharmaceutical regulatory affairs. With over 4 years of experience in leadership in the professional association and more than 8 years in the pharmaceutical regulation , he has been instrumental in pioneering the establishment of the East Africa regulatory affairs professionals association, an important plat form for regulatory information sharing, capacity building and cooperation’s among the East African and African pharmaceuticals regulatory system. Mr. Abebe holds Msc. in pharmaceutical regulatory Affairs from Addis Ababa University and Bpharma from Mekelle University.

A passionate advocate for the advancement of pharmaceutical regulation in Africa , Mr. Abebe regularly speaks at international conferences, sharing his insights on the future of regulatory landscape in East Africa region and the continent at large.

Dr. Mona Al Moussli is a trailblazer in the field of pharmaceutical and medical device regulatory affairs in the Middle East. With over twenty years of experience, she has firmly established herself as a seasoned professional renowned for her unparalleled expertise in navigating the intricacies of healthcare regulations.

Throughout her career, Dr. Al Moussli has demonstrated an unwavering dedication to upholding the highest standards of ethics and compliance within the industry. In 2013, she co-founded PRA Consultancy, a firm that has since become synonymous with regulatory excellence in the region.

Her impact transcends traditional boardroom boundaries as she actively works to shape the future of healthcare regulation through education and advocacy. Notably, Dr. Al Moussli played a pivotal role in the inception of the GCC Regulatory Affairs (RA) Course, a pioneering certification program designed to nurture the next generation of industry experts.

Fueled by her passion for advancing health and safety standards, Dr. Al Moussli has spearheaded numerous initiatives, including the renowned GCC Regulatory Affairs Pharma Summit and other significant gatherings focused on pharmaceutical-related regulations in the region.

Dr. Al Moussli’s commitment to advancing regulatory standards transcends borders, as evidenced by her initiation of the AFRI Summit. This crucial platform facilitates discussions on pharmaceutical and medical device regulations in Africa, fostering knowledge sharing and collaboration among stakeholders to improve healthcare outcomes across the continent.

Beyond her professional achievements, Dr. Al Moussli remains actively involved in community engagement, serving as an advisory board member at Dubai Pharmacy College and lending her expertise to the Women’s Business Council at the Dubai Chamber of Commerce. In recognition of her outstanding contributions, Dr. Mona Al Moussli was elected as a board member of the Emirates Medical Association – Pharmacy chapter for consecutive terms in 2021 and 2022.

With a PhD in Biosciences, Alessandro has extensive experience in defining and driving regulatory policy strategies to support the development of novel vaccines and medical technologies. Previously, Alessandro worked at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, supporting on global vaccine regulatory policy. Alessandro started his career at GSK, working in various regulatory affairs functions.

Dr. Chantalle is the Focal Point of the WHO-AIRP collaborative procedure for the evaluation of medicines and vaccines for WHO prequalification.

Dr. Ahmed is the Country Head for Opella “Sanofi Consumer Healthcare Business Unit” in Egypt. He has over 17 years of experience in FMCH industry across the Middle East.

Before being named Country Head in June 2024, Dr. Ahmed was responsible for Opella’s Allergy portfolio within AMET (Africa, Middle East & Turkey) Zone,

Prior to joining Sanofi Consumer Healthcare in 2015, Dr. Ahmed used to work at the Consumer Healthcare division of Johnson & Johnson (now known as Kenvue). He has managed a wide portfolio across North & West African countries.

Dr. Ahmed earned an MBA (Masters of Business Administration), Major Marketing from The Arab Academy for Science & Technology in 2011 and a Bachelor of Pharmaceutical Science from Faculty of Pharmacy, Cairo University in 2007. His passion is about making self-care simple and accessible for everyone.

Dr. Ahmed El-lekawy is the founder of the General Administration of Innovative Products at Egyptian Drug Authority. He issued the first innovative products’ regulatory guideline to permit the registration of innovative products for the first time in Egypt. He also was the previous head of pharmacoeconomics unit at Egyptian Drug Authority. During operation of pharmacoeconomics unit, he updated Egyptian pharmacoeconomics threshold for better pharmacoeconomics practice in Egypt.  Dr. El-lekawy has a great drug registration & pricing experience gained from working for Egyptian Drug Authority for more than 7 years. Also he has a sound knowledge of clinical nutrition gained form working for Knew Kasr Al-Aini Teaching hospital as a parenteral nutrition pharmacist for more than 4 years. Dr. El-lekawy has strong research capabilities with a Master’s degree in pharmacology and toxicology from Cairo University & excellent knowledge of data analysis & statistics.

He is Vice Chairman of the Unified Procurement Authority, Egypt since 2020, responsible for supply chain management of the Egyptian governmental healthcare sector, covering all the healthcare spectrum of needed products.
• CEO, El Gomhouria Co. for chemicals and pharmaceuticals 2018-2020, a well-known public sector major pharmaceutical and medical supplies company.
• Physician, Ain Shams University, Cairo, Master of Surgery.
• MBA, Supply Chain Management, and International Trade Logistics.
25 years of experience in business management in different fields including healthcare & pharmaceutical manufacturing, FMCG, trade and distribution both locally and internationally.

Ramez Sawiris serves as the R&D lead for Haleon Middle East and Africa and is the Vice Chair of MENAP-SMI (Middle East, North Africa, Pakistan Self Medication Industry), where he has played an important role in leading discussions on self-care in the region. With over 20 years of experience in the pharmaceutical and consumer healthcare industries, Ramez oversees the research and development activities across the MEA region, ensuring the delivery of innovative and high-quality products that align with consumer needs and regulatory standards.

Ramez holds a robust background in regulatory affairs, regulatory strategy development, pricing, and external engagement. Through his leadership, Ramez has built and maintained strategic partnerships with key stakeholders including government agencies, industry associations, and healthcare professionals, reinforcing Haleon’s commitment to deliver better everyday health across MEA. Ramez also holds an MBA in Management from the University of Bradford and a Bachelor of Science in Pharmacy from Cairo University.

 Work Experience:

Haleon

• R&D Lead, MEA (July 2022 to Present)

GlaxoSmithKline Consumer Healthcare

• R&D Senior Director, MEA (2021- July 2022)
• Regulatory Affairs Director -MEA (2014-2021)
• Regulatory Affairs & Quality Director Middle East (2011-2014)
• Regulatory Affairs Director MEPITEL (2003-2008)

Eli Lilly

• Sales, Regulatory and Marketing roles Saudi & Gulf (1994 – 2003)

Education:

MBA Management (1998-1999) – University of Bradford – United Kingdom

Bs Ph, Pharmacy (1988-1993) – Cairo University – Egypt

Dr Nancy Ngum is a Public Health Expert at the African Union Development Agency (AUDA-NEPAD) working under the African Medicines Regulatory Harmonization (AMRH) initiative. Her primary responsibility is focused on the operationalization of the African Medicines Agency (AMA), by supporting the coordination of the Regional Medicines Regulatory harmonisation programmes. She is also leading the team of experts in Africa tasked to oversee the development of a Regulatory Information Management System (RIMS) and Regulatory Information Sharing Platform (RISP) for Africa. She is passionate about patient access to safe, quality and efficacious medical products and has embarked on conducting studies to assess the performance of Regulatory Review Systems with a view to improving patients’ access to Medicines in Africa. Dr Ngum holds a Ph.D. in Regulatory Sciences from the University of Hertfordshire in the United Kingdom. Based on her passion, she has authored several publications in top medical journals and has published a book on “The Role of Regional Initiatives in the Operationalization of the African Medicines Agency

Sybil a Ghanaian and a Pharmacist with 35 years’ experience and 25 years as Pharmaceutical and Quality Assurance Analyst. She was the former Ag. Principal Program Officer for Public Health and Pharmaceuticals as well as the Head of Public Health Division of West African Health Organization (WAHO) for the past 14 years. She was the MRH coordinator and currently on retirement but supporting the West Africa Medicines Regulatory Harmonization Initiative (WA-MRH), the Pooled Procurement Mechanism and eCTD development in the ECOWAS region. Sybil supported must of the Regulatory Agencies in the ECOWAS region to achieve Autonomy as well as strengthen their regulatory systems, quality management systems and WHO Global benchmarking maturity levels of which FDA-Ghana and NAFDAC- Nigeria have obtain ML3 while others are in ML2.

She has been instrumental in the development and implementation of the Africa Medicines Regulatory Harmonization Initiative (AMRHI) and the development of the Africa Medicines Agency Treaty as well as the preparations towards its establishment. She has impacted a lot on the human resource training and capacity development of regional professionals and experts in the pharmaceutical sector, supported building of most local manufacturers capacity to comply with Good Manufacturing Practices (GMP) in the ECOWAS region.

She is a PhD candidate in Public Health Administration and Policy (Walden University-USA) and Lead Auditor for (ISO 45001:2018-OHSMS, ISO14001:2015-EMS, ISO9001:2015-QMS, ISO17025:2017-QCL. Coordinated the ECOWAS COVID-19 vaccines Taskforce to ensure effective access of COVID-19 vaccines and other medical products for the region during the pandemic. Identified 5 local vaccines manufacturers in the region, supported and each of the manufactures are at different levels of development to produce various vaccines from 2024 to enhance the existing vaccine industry of which one is an antigen developer and the another has started producing anti-snake serum in Ghana. Sybil is a Regulatory Consultant and the CEO for SNAAP Access.

Sakhile Dube-Mwedzi is the Co-ordinator for the SADC Medicines Regulatory Harmonization (SADC MRH) Project. A pharmacist by profession and a regulatory scientist at heart, Sakhile has been involved with the project since 2015. Her role and responsibility is to support the Host Agency – the Medicines Control Authority of Zimbabwe, joint SADC/NEPAD Agency Secretariat and SADC Regulators Forum and coordinate overall project implementation, including ZaZiBoNa activities, across all SADC Member States.

Dr. Yasmine Mohamed Hisham is currently serving as the Manager of the Evaluation Unit for Imported Pharmaceuticals at the Egyptian Drug Authority (EDA) since November 2021. A 2011 graduate of Cairo University’s Faculty of Pharmacy, she is responsible for the evaluation, registration, and market authorization of both imported and local human pharmaceuticals, ensuring they meet the required standards for safety and efficacy. She has experience in pharmaceutical regulation, having previously led regulatory affairs for key ministerial decrees.

I am a pharmacist by training and graduated with Masters of pharmacy in Pharmacoepidemiology and Pharmacovigilance from University of Nairobi and a fellow in Anti-Microbial Resistance (AMR) from the London School of Hygiene and Tropical Medicine.

I am a senior 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, pharmacovigilance and post-marketing surveillance. I have special interest in drug utilization studies and medicines regulatory sciences.

She is the General Manager of Biological Products general administration in addition to being the Head of biological products Marketing Authorization Administration at Egyptian Drug

Authority.

She had a bachelor’s degree in pharmaceutical science.

She had a master’s degree in business administration in project management.

She is an external evaluator (assessor of biological products & vaccine) at African Union Development Agency- NEPAD.

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.

Head of National Control Laboratory. National regulatory authority since 2023. Tunisia.

Chief Department «Pharmaco-Toxicology» Department at the Tunisian National Drug Control laboratory since 2018.

Responsible for the evaluation of Biologics, Biosimilars, blood derivatives, and Human and veterinary Vaccines dossier since 2008.

BACKGROUND

• Participation to WHO « CMC assessment of Covid Vaccines pandemic » in the frame of pandemic response.
• GMP Auditor of Foreign biological/Biosimilar Production Sites. Ministry of Health.
• Senior Specialist in Pharmacology. MOH.
• Certified Professional in Healthcare Quality. CPHQ. National Association in Healthcare Quality. Chicago.

Leadership and Management in Health. University of Washington. Department of Global Health.

• Fundamentals of Implementation Science in Global Health. University of Washington. Department of Global Health.
• Member of « Covid19 vaccin scientific committee » since January 2021.
• Member of the Scientific counsil of « National Control laboratory » since January 2019.
• Participation to the elaboration of « Tunisian Guidelines for registration of biosimilar products ».
• Member of Biosimilar PT committee since 2018.
• Formerly
• Clinical Pharmacologist. Drug Information Center Supervisor. Hospital “King Abdul Aziz &Oncology Centrer” (K.A.A.H). Jeddah. Saoudi Arabia.
• Quality Consultant in Hospital Pharmacy Hospitalière. Certification Program. Mekkah Region Quality Program. Saudi Arabia.

Dr. Marwa Souei is the Head of Regulatory Affairs across Africa, Middle East and Turkey at Sanofi Consumer Healthcare (Opella). With an extensive background as Regulatory, Medical, Quality and Pharmacovigilance Expert in Pharmaceutical Industry, she holds a PhD in Pharmacy and a Master’s Degree in Quality Management in the Health Field.

She brings a wealth of experience gained from Local, Regional and Global roles within Multinational Pharmaceutical companies.

Marwa has been instrumental in shaping and implementing innovative business models across Africa and is passionate about driving science inspired innovation to meet healthcare needs. Her leadership continues to foster regulatory excellence and strategic insights across the regions she oversees.

Dr. Yousra is a Regulatory Affairs and Commercial & Distribution Quality Assurance Director, Strategic Project Lead with over 20 years of diversified experience from various leadership positions in Regulatory Affairs, Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.

Dr. Yousra is currently leading Abbott-Gulf, Levant & Emerging Markets Regulatory Affairs, Quality Assurance and Strategic Projects. In her role in Abbott Established Pharmaceutical Division; Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.

Dr. Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM & Levant.

On top of that, she set the base for strategic projects within the Gulf & Emerging Markets and lead the execution of a variety of initiatives that support patient centricity.

Dr. Yousra is holding a bachelor of pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.

Zivanai is a highly motivated pharmaceutical regulatory science professional with more than 12 years’ experience. He has vast experience in various aspects of human, complementary (herbal and nutraceuticals)  and veterinary medicines regulation such as product quality, safety and efficacy assessments. Zivanai is proud to have participated as an important team member during the pioneering of medicines assessment and GMP inspections under the SADC Regulatory harmonisation initiative (ZAZIBONA) from 2013 to 2017. His current role at MCAZ is the Chief Regulatory Officer responsible for leading the evaluations team in the Evaluations and Registration Division.

Dr. Mohamed Larbi Jelassi holds a PharmD with a specialty in Industrial Pharmacy from Monastir University and Paris Descartes University, as well as a master’s degree in Management in Health Care from Paris Sud University. With 17 years of experience in the pharmaceutical industry, he has developed expertise in Market Access, Regulatory Affairs, Corporate Affairs, and Marketing across the Middle East and Africa.

Je suis zineb housni, pharmacienne inspecteur, évaluatrice des dossiers d’autorisation de mise sur le marché des médicaments à usage humain depuis janvier 2015

Direction de Médicament et de Pharmacie – Maroc

Good evening.

I am Zineb Housni, Pharmacist Inspector, Evaluator Of Marketing Authorization Files For Medicinal Products For Human Use Since January 2015

Directorate of Medicines and Pharmacy – Morocco

Eric Konan, Regulatory Affairs Director with expertise in Team Management, New product introduction, license maintenance, portfolio optimization, management of technical and labelling variations for global pharmaceutical organizations.

Eric Konan holds a Doctorate in Pharmaceutical Sciences from Felix Houphouet Boigny University of Abidjan (Cote d’Ivoire).

He has Demonstrated ability to manage regulatory risks and set up appropriate mitigation plan to prevent issues.

Very attached to innovation, Eric is continuously challenging the statu quo to improve performance and outcomes.

Member of regulatory committee of LIPA (Pharmaceutical Industry trade association), Eric has demonstrated passion and commitment for negotiation and advocacy with Public and Private stakeholders for solving problems and improving the regulatory environment in Africa.

Mr. Lyoko Nyambe is a pharmacist with over seventeen years working experience, four of which were spent in hospital pharmacy practice and thirteen as a regulator.

The areas of expertise include marketing authorisation, clinical trials, and pharmacovigilance. In addition, he has also been managing inspectorate functions as such as licensing, GMP and GDP inspections, PMS, and safe disposal of medicines in the country for over 4 years.

Fransina is  a qualified pharmacist with vast experience in the pharmaceutical sector. Currently finalizing a   Master’s program in Pharmaceutical Policy Administration and Regulatory Affairs. I  have worked in the medical benefit management industry, community pharmacy, medicines policy and coordination, drug research and development  and most recently medicines regulation as Registrar of Medicines and head  of the Namibia Medicines Regulatory Agency.I am also an alumni of the Afrika!Kommt Fellowship program and  have served as member of the Namibia Pharmacy Council as well as assisted  the Health Professionals Council of Namibia in various portfolios including as member of the Appeal Committee of the Medical and Dental Council of Namibia.In addition I am a a Commisioner of the National Drug Commission and an ex-officio member of the Namibia National Immunization Technical Advisory Group.

My current role as Registrar of Medicines in Namibia , is a challenging yet rewarding role , one which enables contribution to the critical need of public health service delivery for all Namibians , in ensuring that our population has access to safe , effective and quality assured medicines and medical products. This responsibility goes beyond the boardrooms of our offices , ministry and country , as it requires engagements with key stakeholders internally , within the region , continentally and indeed on a global scale to facilitate initiatives which will strengthen the regulatory systems of our country, including legislative reforms , enhancement of expertise and skills development for our staff , acquisition of regulatory information management systems, and enabling harmonization and collaborative working platforms to facilitate timely access to treatment for every citizen seeking healthcare in Namibia.

Dr. Fatima Zaid Abu Zanat is an accomplished Regulatory Affairs/Quality Assurance (RA/QA) professional with a total of 17 years of experience spanning the medical device, pharmaceutical, and biotech industries across emerging markets. She holds a Master of Science in Pharmaceutical Technology and the prestigious RAPS Dual Regulatory Affairs Diploma and Certificate. Dr. Abu Zanat possesses a strong scientific background in product research and development and is keen on strategic best practices implementation. A distinguished speaker and panel moderator at key regulatory conferences, Dr. Abu Zanat actively contributes to industry-wide, regulatory discussions. Her dedication and contributions have not gone unnoticed, where she was honored by the GCC Regulatory Affairs Award in 2023 for her outstanding achievements and impact in the region as the “Woman of the Middle East”. She is actively engaged in regulatory and industry associations. She is also recognized for her leadership in establishing and managing UAE Scientific Offices, fostering growth, and building strong relationships with regional health authorities. Beyond her professional endeavors, Dr. Abu Zanat has made significant contributions to international publications, highlighting her thought leadership and expertise. Her accolades, including nominations such as the Women of Ipsen Nomination and the DUPHAT 2012 3rd Best Professional Poster Award, underscore her commitment to innovation and excellence.

Dr. ABATOUR holds a Doctor of Pharmacy from Mohammed V University of Rabat. She is the Chief of Medical Device Unit at Directorate of medicines and pharmacy in Morocco. With over 10 years of experience in hospital pharmaceutical management and regulatory affairs, her technical and regulatory expertise enables her to meticulously evaluate the medical device registration files.

Dr Kurdi is currently working as Regulatory Affairs & Public Policy Senior Manager 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 nationally and international; with
JFDA on re-registration of generic products, Control of Pharmaceutical Products, Control of Active
Pharmaceutical Ingredient used in Pharmaceutical Product, Value Added Medicine and Site
Accreditation Committee. With United State Pharmacopeia as an expert in the advisory panels of
General Chapter (1197) and with International Generic and Biosimilar Medicine Association (IGBA)
representing JAPM in Biosimilar Committee.
Dr Kurdi has many research papers published in Scientific Journals and she is frequent speaker in
Pharmaceutical Conferences.

Jacqueline Acquah is a registered pharmacist in Ghana and holds an MPH from the University of Ghana.

Jacqueline has over 16 years of experience in healthcare, with a significant number of those years being in regulatory affairs.

She previously worked for Johnson & Johnson as an Associate Director responsible for vaccines regulatory affairs in emerging markets in Eastern Europe, Middle East, and Africa (EMEA). There, she was instrumental in developing strategies in obtaining Emergency Use and Marketing authorizations to potentiate access to J&J vaccines in over 50 LMICs, particularly COVID-19 vaccines, during the COVID-19 pandemic. She was also instrumental in working with the WHO/AVAREF, Africa Vaccines Regulatory Forum during the COVID-19 pandemic, to shape the regulatory ecosystem for emergency use authorizations.

Jacqueline also served as Co-Chair for the Africa Regulatory Network (ARN) of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and was a member of IFPMA’s Regulatory Science Committee (RSC), the highest regulatory decision-making body of the IFPMA. Together with other industry colleagues, she led the association to work in collaboration with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonization of regulatory requirements on the African continent and strengthening of the regulatory ecosystem.

Through the IFPMA, she has supported the work of the AMRH since 2018, sitting on various TCs and contributing to regulatory harmonization on the continent.

Prior to joining J&J, Jacqueline worked with Pfizer, leading corporate regulatory strategy in West and Central Africa.

Jacqueline has also previously worked the 37 Military Hospital and the Pharmaceutical Society of Ghana. Jacqueline has contributed to several regulatory publications on Africa and spoken at various international regulatory affairs fora.

Pharmacist and Project Manager, leading the digital transformation of the Agency of Medicines and Health Products (ANMPS), overseeing both the integrated information system and the eCTD components. Serving as the focal point for the National Pharmaceutical Policy project at ANMPS, Dr Aounallah is also a member of the provisional secretariat of the NA-MRH initiative and sits on the ANMPS implementation committee, contributing to the strategic advancement of pharmaceutical regulation and policy in Tunisia.

Meet Gorkem, a dedicated International Marketing Manager at VISIOTT, specializing in Track and Trace solutions and Vision Inspection systems. With a fervent enthusiasm for data analytics and international trade, he thrives in fostering global partnerships and driving
tangible results. He brings a wealth of experience to his role and is committed to pushing the boundaries of innovation in his field.

Tutku is a dynamic Marketing Director at VISIOTT, where she leads strategic marketing efforts in the track and trace industry. Renowned for her expertise in shaping effective marketing solutions, she consistently seeks to enhance customer relationships in
international markets. With a people-first mentality and a wide range of interests, Tutku views every professional interaction as an opportunity to build strong, lasting partnerships and deliver impactful results

He is the Chief Executive officer of EVOTEQ, a UAE-based digital solutions provider. Jihad is a leader in the technology and telecom industry in the region, bringing in his wealth of experience and expertise to spearhead the development of advanced technology solutions that increase efficiency, support business growth, and fuel digital innovation. Under his leadership, EVOTEQ has successfully achieved numerous milestones, undertaking several large-scale landmark projects.

Dr. Ivan Emil is a Microbiologist and a seasoned Public Health Laboratory Scientist with over a decade of experience as the Division Manager at Rwanda’s National Reference Laboratory. His management led to the laboratory attainment of ISO 15189. His extensive background encompasses regulatory affairs at national, regional, and international levels, with a strong emphasis on infectious diseases through research and academia work skillset.

In his current role at the Rwanda Food and Drugs Authority (Rwanda FDA), he serves as a Technical Analyst, responsible for the assessment of medical devices, in vitro diagnostics (IVDs), vaccines, and biologicals. At Rwanda FDA, He has played a key role in implementing regulatory reliance and recognition pathways, streamlining registration processes for medical devices and IVDs to facilitate efficient market access. His involvement in the Rwanda FDA Quality Management Committees further underscores his commitment to advancing regulatory standards and improving practices through collaborative pathways.

Dr Ivan’s contributions are essential to the ongoing development of medical device regional harmonization regulations, ensuring registration of quality product on Rwandan Market that are safe and efficacious to fit Rwanda FDA long term mandate of protecting public health

Dr. Fazila is a Regulatory Affairs  over 15 years of diversified experience from various leadership positions in Regulatory Affairs , Quality Assurance Pharmacovigilance outsourcing  Project Management  within multinational organizations at both regional and local levels.

Dr. Fazila  is currently leading  French Africa speaking cluster Regulatory Affairs,. In her role in Abbott Established Pharmaceutical Division; Fazila is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as Regulatory risk mitigation and regulatory compliance.

Dr. Fazila has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers.

Dr. Fazila is holding a bachelor of pharmaceutical sciences from Algeria University and has a lot certifications   in project management leadership for results and Market Access

An Industrial Pharmacist of 30 years. Started her career at Adcock Ingram (pre – Sterling Winthrop) in production of Panado tablets and Syrup before moving to Smith & Nephew in 1992, which became BSNmedical (2001), National Bio-products (20004) as Pharmacist Plant Manager (ampoules / Vials ) followed by own Consulting business 2005.

At Smith & Nephew, introduced to medical devices such as burns creams, wound dressings, bandages and plasters and the new quality management system, at the time, ISO9001 and moving to ISO 13485 in 2000.

Worked in Production, Quality Assurance, Regulatory affairs, Validation and Laboratory Management of a chemistry, microbiology and textile laboratory.

In 2005, the consultancy business started providing.

• Consultation on quality management systems (ISO9001/22001/13495) regulatory requirements, product licensing, company registration for medicines and medical devices
• Training in-house or public venue on the development, implementation and maintenance of a quality managements system (ISO13485), good manufacturing practices and internal auditing for conformity assessment certification and
• Documentation requirements for risk assessment (ISO 14971), procedures, clinical evaluation, technical file and declaration of conformity

A member of PSSA, SAAPHI, SAHFE, SAMED, MDPG (Chairperson 2019) MDMSA (chairperson 2021), and is a committee member of the SAMED Regulatory and Procurement committees and the SABS Technical committees for textiles and medical devices

Dr. Rachel J Mujawimana is a pharmacist with 14 years of experience in the pharmaceutical sector, covering community and regulatory pharmacy. She currently works as an Inspector of Drugs at the Uganda National Drug Authority, where she is responsible for ensuring the quality and safety of medicines and medical products in Uganda.

Dr. Rachel is the focal person for medical devices within the Directorate of Inspectorate and Enforcement. She holds a Master’s degree in Pharmaceutical Sciences from Trinity College Dublin and is certified in ISO 13485, specializing in quality management systems for medical devices.

In her role, Dr. Rachel has been actively involved in screening imports of drugs and medical devices to ensure compliance with regulatory standards. She has also contributed to policy discussions on Uganda’s new legislation regarding medical devices and carried out audits of manufacturers, improving regulatory compliance and raising safety standards. Dr. Rachel is dedicated to advancing public health and ensuring that safe, high-quality medical products are accessible to all.