THIS YEAR SPEAKERS
Gayane Kiragosyan Msc is a Product Safety Officer/Medical Writer and Certified MedDRA Coder at GCP-Service International. She is responsible for executing all activities relating to pharmacovigilance and medical device vigilance. Qualifying as a biologist, Gayane started her career in clinical research 4 years ago. She is deeply familiar with safety reporting during clinical trials in the European Union and the unique perks and challenges that safety reporting brings to clinical trials.
Priscilla Nyambayo: Clinical pharmacologist, Head-Clinical Trials & Pharmacovigilance
Division, Medicines Control Authority of Zimbabwe (MCAZ)
Contact Details: Medicines Control Authority of Zimbabwe (MCAZ) 106 Baines Avenue Harare, Zimbabwe.
Professional Summary and skills:
✓ Leadership and inspiration: She is a motivated and inspired clinical pharmacologist who is
employed as Head of Pharmacovigilance and Clinical Trials -MCAZ with a history of
achievement in regulation of clinical trials and co-founder of the national pharmacovigilance
center. She is a motivated leader with strong organizational, prioritization abilities including
passion for patient safety.
✓ She successfully led the MCA- Clinical Trials Oversight (CTO) regulation system to be
awarded Maturity Level (ML3) by the World Health Organization (WHO) Global Bench
Marking Tool (GBMT) assessment on 27th August 2021.
✓ Consultant in clinical trials regulation and pharmacovigilance: She is a consultant for
pharmacovigilance, clinical trials regulation, GCP inspections, and successfully managed
several projects co-funded by regulatory partners such as WHO, UNICEF, Global Fund and
Paul Ehrlich Institute (PEI) Vacci Train and Blood Train, Global Heath Projects. This included
cofacilitation of several GCP, Pharmacovigilance and Training of AEFI Committees in Africa
at WHO and/or PEI organized workshops in Africa. She is a consultant advisory member of
the WHO African Vaccines Regulatory Forum (AVAREF) Technical Coordinating Committee
(TCC) from 2016 to date. She also successfully led development of the MCAZ national online
E2B compatible pharmacovigilance(ePV) system and clinical trials application & registry
✓ Membership to societies and advisory committees: She is a member of the International
Society of Pharmacovigilance (ISoP) and cofounder of the African Society of
Pharmacovigilance (ASoP). She is also a member of the Advisory Committee of the African
Academy of Sciences (AAS) that recently set up online clinical trials community (CTC)
✓ Education: She is a PhD student at the University of Cape Town researching on active
vaccines safety surveillance. She has a master’s degree in clinical pharmacology from
University of Zimbabwe (2001), BSc Hons. in Pharmacology at Kings College, University of
Sanjeev S Gadhia is the Founder and CEO of Astral Aviation Ltd which is a cargo-airline with a fleet of 14 Aircrafts and a Network of 50 Destinations which are connected via the Nairobi, Johannesburg, Dubai and Liege Hubs.
Astral offers a reliable air-freight and logistics solution for Pharma including the Covid vaccine as it has 20 years of experience with the distribution of Pharma and Vaccines within Africa, Middle East and Europe.
Senator in Parliament of ZIMBABWE
Medical Doctor (MB., BS FCPCP)
Specialist Family Doctor
BSc Degree in Applied Chemistry
Former Minister of Health (15 years)
Past President of the World Health Organisation (W. H. O.)
Health, Child Welfare and the Elderly Secretary in ZANU PF Politburo
Fellow for the College of Primary Care Physician (FCPCP) (ZIM)
Past President of College of Primary Care Physician (FCPCP) (ZIM)
Past Chairman Medical Research Council – Zimbabwe (MRC-ZIM)
UNAIDS Chair of Programme Coordinating Board (PCB) 2015
Past Chairman of WHO (AFRO) Ministers of Health
Past Chairman Ministers of Health of SADC
Executive Director CHESTMEDICAL (Centre for Health Strategies)
Dr Ahmed Ogwell currently serves as the Deputy
Director at the Africa Centres for Disease Control
and Prevention (Africa CDC) – a specialised
agency of the African Union (AU). In this
capacity, he works with AU Member States and
other partners, leading a team of experts in
securing Africa’s health through effective
preparedness, early detection and rapid
response to disease outbreaks and public health
emergencies on the continent of Africa.
Dr Ahmed Ogwell has over 25 years of
experience in public health as a social and
developmental agenda at national, regional, and
global levels. He has ably held senior positions in
national government, the United Nations (UN)
system, non-governmental organisations, and
Dr Ahmed Ogwell previously worked as an advisor to the World Health Organization Director
General and worked at the World Health Organisation Regional office for Africa.
Dr Ahmed Ogwell is an alumnus of the University Of Nairobi School Of Public Health and the
Centre for International Health at the University of Bergen in Norway. He is married with
Myriam Razgallah Khrouf is Professor of Pharmacology at the Faculty of
Pharmacy, University of Monastir, Tunisia, and Director of the Unit of Pharmacy
and Drug at the Tunisian Ministry of Health.
Her main fields of expertise are drug regulatory policies, pharmacokinetic assessments, and pharmaco-economics. She has been member of the scientific board of Hopipharm, a network of Francophone hospital pharmacists, and was the General Secretary of the Tunisian Society of Oncology Pharmacy and member of the European Society of Oncology Pharmacy. With a group of colleagues she established the pharmacoeconomie certificate at the faculty of pharmacy at Monastir.
During the COVID-19 pandemic she has supported the coordination of vaccines national registration, the enrollment of Tunisia in COVAX initiative and
the World Bank financial country package.
Sybil Nana Ama OSSEI-AGYEMAN-YEBOAH, has 31 years’ experience as a Pharmaceutical and Quality Assurance Analyst. For the past 11 years plus has been at the West African Health Organization (WAHO) as the Professional Officer in charge of Pharmaceuticals and other Health Products and now the Ag. Principal Program Officer for Public Health. Coordinates the West Africa Medicines Regulatory Harmonization Initiative, trained and created regional experts in the pharmaceutical sectors to strengthen the human resource for the job force, medicines regulatory systems strengthening, quality control laboratories capacity and infrastructure accreditation, local manufacturing capacity development and good manufacturing practices. These and other interventions are to ensure best health practices in the Economic Community of West African States (ECOWAS) region. Currently coordinating the ECOWAS COVID-19 vaccines Taskforce to ensure effective access of COVID-19 vaccines and other vaccines production in the region.
Dr. Peter M. Mathuki is the current Secretary General of the East African Community. He was appointed with effect from 25th April 2021. Before his appointment to the EAC, Dr. Mathuki was the Executive Director of the East African Business Council (EABC), the regional apex body of Private Sector associations and corporates in the East Africa. Dr. Mathuki was actively involved in the establishment of the African Continental Free Trade Area and was part of the efforts to establish the African Business Council, “an independent private sector institution of the African Union”. Dr. Peter M. Mathuki holds an MBA and PhD in Strategic Management & Regional Integration from the University of Nairobi, Kenya. He also sits on the board of Kenya Investment Authority, based in Nairobi and the Inter-University Council for East Africa, based in Kampala. He is also a member of the Kenya Institute of Management.
Pharm Joy Iloani-Nwankwo is currently an Independent Managing Regulatory Consultant at Pharma Novelty Limited. Pharma Novelty Ltd is a company established to serve as a solution hub for complex regulatory issues within the Nigerian food and pharma sectors.
Joy strives to provide comfort and care for her patients through careful formulations of treatment that can also save their lives. Joy believes that proper self-care coupled with the right supply of medicines will help her patients maintain a healthy lifestyle.
Joy works with her current clients to develop new models to provide sufficient patient care to achieve the desired results.
Joy graduated with a Bachelor of Pharmacy Degree at the University of Benin, Edo State, Nigeria in 1984.
She served under the National Youth Service Corps (NYSC) Scheme at the Lagos State Ministry of Health, Pharmaceutical Services Division.
Her one-year Internship was at the Prestigious University College Hospital (UCH), Ibadan, Oyo State, Nigeria.
She practiced as a community Pharmacist in her early years as the Chief Executive officer of her own Company.
In the year 2000, Joy opted to join the National Agency for Food Administration and Control (NAFDAC) where she served successfully until her retirement. She is a trained Facility Auditor, trained Dossier Evaluator for Drugs, Medical Devices and Vaccines.
In NAFDAC, she worked at different Directorates of the Agency and some International/National assignments amongst which are:
• Head of the Narcotics & Psychotropic substances and Drug Demand Reduction Divisions, both Narcotics and Controlled Substances Directorate.
• Head of the Drugs manufactured in Nigeria, Cosmetics and Herbal Medicines/ Nutraceuticals Divisions, Registration and Regulatory Affairs Directorate.
• Assistant Director, Imported Drugs, Registration and Regulatory Affairs Directorate.
• Worked at the Establishment Inspection Directorate Office at different States some of which she headed. These includes but not limited to Plateau, Ebonyi, Enugu and Imo States.
She retired as a Deputy Director from the National Agency for Food and Drug Administration and Control (NAFDAC)- The National Regulatory Authority in Nigeria.
Other assignments during her career:
• Member, Enugu and Ebonyi States Task Force on Counterfeit and Fake Drugs/ Unwholesome Processed Food
• Focal Person for Clinton Health Aids Initiatives (CHAI) and UN Commission on Life Saving Commodities
• Headed the Dossier Evaluation Team (R&R)
• Focal Person for Malaria Control Program
• Headed the In-House Capacity Building Desk (R&R) where she developed Training Manuals and facilitated training programs for staff.
• Presented many papers at various workshops and conferences, locally, regionally, and internationally.
• Member Pharmaceutical Society of Nigeria (PSN)
• Member Royal Pharmaceutical Society (RPS)
• Member Nigerian Institute of Management (MIN)
• Member Nigeria Institute of Food Science and Technology (NIFST).
Mrs. Jonniah William – Mollel is currently the Chief Executive Officer
at East African Health Platform (EAHP) serving the 6 East Africa
Community Partner States namely Burundi, Kenya, Rwanda, South
Sudan, Tanzania mainland &Zanzibar and Uganda. Her duty is to
oversee the platform’s growth while facilitating interaction between
the EAC and the health businesses and Non-Profit private operators by
promoting cross boarder markets and partnerships.
She holds a Master of Science in Research & Public Policy, a Post
Graduate in Management of Foreign Relations and a Bachelor Degree
in Political Science and International Relations
Before joining the platform, Ms. Mollel worked for 6 years at EANNASO as a regional Technical
Advisor for TB and HIV advocacy. Previously she worked at UNAIDS Country Office in Tanzania
serving the Development Partners Group on HIV and AIDS to enhance cooperation with the UN
family and the Government of Tanzania mainland and Zanzibar.
-Head of biological products registration department at Egyptian Drug Authority.
-Former head of variation department of biological products.
-Team leader for setting registration guideline of plasma derived medicinal products.
– member in the team of updating registration guideline of biosimilar product in EGYPT.
-member in the WHO team for assessing vaccine submitted for EUL.
Director of Clinical Operations with more than 16 years’ experience in line, project and operation management. I was
involved in more than 150 trials from Phase I to Phase IV for different therapeutic indications, including but not limited to
Infectious diseases like SARS-2 COV, rare diseases with an extensive experience in the SCD indication, neurology, …etc.
For the past few years, I oversaw clinical operations (projects and programs) in more than 20 countries located in Middle
East and Africa: Algeria, Tunisia, Morocco, Egypt, Mali, Ivory Cost, Lebanon, Saudi Arabia, UAE, Oman, Kuwait, Qatar,
Jordan, Senegal, Burkina Faso, Gambia, Guinea, Sierra Leone, Ghana, Uganda, Kenya, Nigeria, Mozambique, South
Africa and Zimbabwe.
Asmaa Khalil is manager of Regulatory Affairs at Boston Biopharma. She has more than 15 years’
experience in global regulatory affairs “MENA Region, African Countries, CIS Region, APAC region, US &
Asmaa is expert consultant in CTD, NeeS & eCTD compilation and submission/publishing of dossier.
She was the speaker of more than 30 workshops in Egypt & GCC for regulatory affairs and CTD/eCTD
Asmaa has global network contacts with agents and support pharmaceutical companies to start building
new export business worldwide.
Asmaa earned her B.S. in Pharmaceutical Sciences from Cairo University, and her M.Sc. in Biochemistry.
Dr. Bernard S. Haufiku is a Namibian medical doctor and Special Adviser to the Namibian government on health matters with over 20 years of clinical experience both in public and private practice. He is the former Health and Social Services Minister of the Republic of Namibia, having held the position between 2015 and 2018. Dr. Haufiku, an avid supporter of HIV management, primarily focused on reducing maternal mortality by eliminating mother-to-child HIV transmissions while he was a minister.
Dr. Haufiku has also served as the chairperson of Namibia Medical Society and a member of the governing board of the Africa Centre for Disease Control and Prevention. Dr. Haufiku has recently accepted a nomination to chair the African Public Health Foundation to be launched by Africa Centres for Disease Control and Prevention and the African Union in February 2020.
Dr. Haufiku has studied medicine at the University of Witwatersrand in Johannesburg, where he received the degrees of Bachelor of Medicine and Bachelor of Surgery. Furthermore, he holds a diploma in Anaesthesiology from the College of Medicine of South Africa. He has taken a clinical course in HIV management at the Foundation for Professional Development in South Africa. Dr. Haufiku had also attended the esteemed Harvard Leadership training in the United States in 2015.
A health professional with extensive experience in quality assurance, organizational
regulatory compliance and health sector advocacy.
Daniella has created and managed quality management systems in the pharmaceutical
distribution supply chain throughout her career.
Armed with a passion for health promotion, education and people empowerment, Daniella
has also mobilized the pharmacy profession in Kenya to successfully advocate for change in
health policies to ensure enhanced reach of primary healthcare. In this regard she has been
part of developing various health policy documents at a global as well as country level.
Dr. Maira Bholla is a Molecular Epidemiologist with over 21 years of broad-based health sector experience in East Africa. She managed the Medical Laboratory at the Aga Khan University Hospital, Nairobi for 11 years. During this time, her technical focus was on HIV diagnostics and in the later years on tuberculosis in children. She is therefore specifically qualified to do the much needed COVID-19 molecular test.
She currently consults in the Health Sector in Africa and Canada and has extensive networks in the public and private sectors in East Africa. Part of her portfolio in the Health industry includes professional counsel and advisory on healthcare projects; including Greenfield, Brownfield, human resource, biotechnology and devices, digital healthcare technologies, supply logistics and foreign partnerships coordination, through her local and international associations, with a special focus on access to cancer care and now, all matters COVID-19. Quality assurance, market research, data analytics, teaching and supervision of postgraduate students are also her forte.
Dr. Amit Thakker is a medical doctor, a visionary entrepreneur, industry captain and ground-breaking pioneer in the integration of the private sector within the health system in Africa. He is currently the Executive Chairman of Africa Health Business and the Africa Healthcare Federation and a Director with AMREF Flying Doctors (Kenya) and Seven Seas Technologies. Dr Thakker received an Executive Master of Business Administration degree in 2007 from National Insurance Academy in India and a Bachelor of Medicine, Bachelor of Surgery degree in 1997 from the University of Nairobi. He was the 2017 recipient of the Best CEO award by Titans Global in the Business and Professional Services category, the 2004 Chairman’s Award by the Kenya Medical Association and the 1999 Best Male Entrepreneur of the Year award by Rotary International. An accomplished champion in healthcare management, he is well recognized for his integrative approach in providing innovative and bold business cross cutting solutions in the health services and financing sector within Eastern and Southern Africa.
Dr. Catherine Mwendwa Maina
Regulatory Affairs Specialist & LPVRP – Glenmark Pharmaceuticals (K) Limited
Msc. Regulatory Science – Purdue University (ongoing)
MBA – International Business – University of Nairobi
Bachelor of Pharmacy – University of Nairobi
Nyeleti Bicky Mthombeni is a current chairperson of the South African Clinical research association (SACRA). SACRA is an industry community association with the sole purpose of leading and serving as a conduit positioning the country at the forefront of clinical research to enhance the health of all South Africans. SACRA Advocate, Educate and Facilitate clinical trials community to realize its mission. As SACRA chair, Nyeleti Bicky Mthombeni is passionate about the growth of the clinical research industry in South Africa. With more than 15 years of experience in the industry, she defines herself as a capacity-building enthusiast that continues to work tirelessly with other members of the SACRA community to further the agenda of clinical trials growth in South Africa. Nyeleti Bicky Mthombeni works as an independent consultant while building a new offering in the clinical trials industry through her newly formed partnership at the Pharma Agent. Doing all this with a clear goal that encourages continuous education in the field, she holds an MSc in project management and pharmacology and is currently a registered Ph.D. student at Stellenbosch university.
Lebogang has over 11 years of working experience in the Pharmaceutical Industry, a fully registered Pharmacist with the Botswana Health Professions Council graduated with a Bachelor of Pharmacy from the Latrobe University, Bendigo Australia.
A Pharmacovigilance and Clinical trials Manager with the Botswana Medicines Regulatory Authority (BoMRA), Lebogang has a firm grip in the Drug Regulatory systems, Market dynamics and Pharmaceutical industry, currently responsible for core PV operational functions including Case Management, and Quality and Document Management, managing the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials.
Doubling as the President of The Pharmaceutical Society of Botswana, Lebogang is involved in the development of Campaigns that promote health care industry and has gone to develop strategic relations and collaborations with stakeholders within the health industry in Botswana and the SADC region. A member of the Commonwealth Pharmacist Association Council, his role includes but not limited to advocating for collaboration and partnership amongst the Commonwealth Pharmacy Associations. A member of the joint taskforce for the Ministry of Health & Wellness and Business Botswana mandated with developing strategic projects that will see private sector collaboration in public healthcare delivery. Also, member of International Society of Pharmacovigilance
LK as he is affectionally known prides himself with the development of safety exchange agreements with license partners and distributors in support of PV collaborations, a firm believer that accomplishments validate facts you already know while setbacks teach the hard lessons.
Yusuf Dawood is the Country Safety head for SANOFI South Africa. He is also the vice chair of IPASA PV
WorkStream. His areas of expertise include Implementation and management of Pharmacovigilance
system including Patient support programs, Market research programs and Digital projects, Safety
Agreements, Risk Management and case management. He has collaborated on projects such as Global
Reconciliation Working Group, Pharmacovigilance education and internal pharmacovigilance campaigns.
He completed his Master of Pharmacy – with distinction at the University of the Witwatersrand. To
further enhance his management skills, he completed Project Management at the Gordon Institute of
Business sciences. Yusuf strives for excellence with his strategic thinking, simplification of processes and
his creative, innovative and inquisitive charms.
Head of the executive team for the Egyptian Pharmaceutical Track & Trace System
Project, being responsible for project management & implementing the
Traceability National Platform for the Pharmaceutical Products for securing against
Substandard, Spurious, Falsely Labeled, Falsified & Counterfeit (SSFFC) products,
securing drugs supply chain around Egypt, ensuring market authorization, and
enhancing market monitoring and control. Being the Deputy Head of the Digital
Transformation Dept. a specialized unit that is responsible for the Digital
Transformation inside the Egyptian Drug Authority. He was also a team member in
the Egyptian Pharmaceutical Supply Chain Reform Project; that is electronically
secures & monitors the availability of all pharmaceutical products all over the
governmental healthcare sector. He is a certified Healthcare Informatician since
2015 (Egyptian Fellowship Board, 2015). For 5 years, he was the Head of
Pharmaceutical Regional Warehouses for Injectable, Emergency & Narcotic
Christine Oyewo is responsible for the implementation of GS1 Standards and Traceability in the
Nigerian Healthcare delivery system and pharmaceutical sector.
Christine is a pharmacist with an MBA and several Supply Chain Certifications including from MIT. She spent part of her career in the pharmaceutical industry and worked in sales and marketing as well as in regulatory affairs. She has great passion for technologies around efficiency and visibility in the supply chain and its positive impact on patient safety and in the fight against substandard and fake medications.
She strongly believes that collaboration among all stakeholders will make this possible in Africa.
As the pioneer of successfully setting up and running Kenya’s first fully approved and regulated Online Pharmacy, Dr. Farzana Sunderji has forged her reputation as an exceptional, forward-thinking Pharmacist by leveraging on technology within the digital era.
Leaving a lucrative career in the UK to come back home to Kenya, Dr. Farzana Sunderji has made it her mission to use her skillset conscientiously and consciously towards improving the pharmaceutical industry in whatever capacity she can, both locally as well as internationally.
She has been recognised for her EQ in every project she has so far undertaken and has proven herself time and again to be a born leader who is able to clearly articulate goals, anticipate where the industry is heading and ensure that she is well up to date with current trends and practices, all the while remaining extremely conscious of Best Practice, Due Diligence and her own set of Ethical and Moral standards.
Every career decision she has made has been backed by the ethos of an exceptionally high standard of care to patients, and to put a patient’s health above financial compensation. Her recommendations on improving how companies operate have yielded phenomenal results and won her deep respect not only among peers but also among end consumers who have commended the changes.
Tshepiso Mabena has a Degree in Nursing ( B CUR), B Tech Biopharmaceutical Sciences and a Certificate in Project Management.
She started her career at Investigator Sites as a study Coordinator and progressed through global CROs and international Pharma Companies: Novartis Vaccines, IQVIA, ClinTect International (contracted to MSD), and GSK.
With 16 years in clinical research experience overseeing all project phases – monitoring, site feasibility, selection, regulatory submissions, budget negotiations, contract management, start-up and Third-Party Oversight, Tshepiso Mabena joined Tigermed in May 2021 within Therapeutic Area of Oncology, Respiratory, Infectious Diseases, Women’s Health and Vaccines.
Tshepiso Mabena focus is to cultivate good relationships with internal and external stakeholders.
Winnie Munene is the Patient Safety and Pharmacovigilance Manager, Boehringer Ingelheim. She is majorly responsible for English speaking Sub-Sahara African countries. Winnie holds a Bachelor of Pharmacy from University of Nairobi, an MBA in Healthcare Management from Strathmore Business School and higher diploma in Industrial Pharmaceutical Advanced Training from Purdue University/Kilimanjaro School of Pharmacy. She is an Afrika Kommt fellow 2017 having worked at Merck KGaA in their Germany headquarters for an year.
Winnie is a conscientious healthcare professional passionate about healthcare access and social equity all in the sphere of corporate governance and ethical business practice. She has close to 15 years in both management and leadership roles in Pharmacovilance, Quality and Regulatory Affairs with cross-functional management responsibilities for healthcare access programs and projects. She has a good understanding and vast experience of local and global regulations & guidelines.
Winnie is focused on building her expertise in pharmacovigilance and patient safety management, medical and pharmaceutical compliance, new drug registration for go-to market strategies, regulatory, quality assurance management, which are paramount for access to medicines for developing countries.
Her ultimate career goal is to be a thought leader in healthcare access projects and programs, driving and managing projects that are geared towards medicine and medical technologies access & availability while supporting go-to-market strategies.
She is also a mother to a 10 year old strong-willed lovely girl.
Since July 2003, Emeka has been playing active role in the West African Food, Drugs,Cosmetics and Medical Devices Regulatory Affairs Ecosystem. His experience cuts across the Nigerian Food and Drug Authority (NAFDAC) as Regulator (cGMP Inspector) and
Industry as a Regulatory Affairs Manager. As a Regulatory Affairs Manger he exceptionally, influenced, navigated and interpreted regulations for businesses in Nigeria and other West African markets.
Emeka’s focus is in simplifying regulatory complexities in West African countries for business growth by creatively interpreting and influencing regulations; bridging knowledge gaps and relationship building between Regulators and the industry. He understands the
thinking of regulatory authorities and the regulatory challenges facing businesses in West African markets.
Currently he leads the Regulatory Affairs Projects Team at CQRAFF Solutions Ltd – a company incorporated by law in Nigeria to render Corporate Regulatory Affairs services to Cosmetics, Pharmaceuticals, Medical Devices & Diagnostics, Food & Nutraceuticals
companies with strong presence in Nigeria and Ghana. In his current role he advises clients on: Strategic Regulatory Consulting for Market access / entry. Regulatory Submissions and Intelligence, Marketing Authorization applications and Post Marketing maintenance, Product Registration and License Management, Site cGMP Inspection Readiness, regulatory audit support services for manufacturing facilities and any other regulatory activity that may arise.
Emeka holds who holds a B.Sc Hons Degree in Applied Microbiology is a senior member of American Society of Quality (ASQ) and a member of the Regulatory Affairs Professional Society (RAPS).
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.
I am a pharmaceutical professional pharmacist; with about 17 years’ experience in Registration & Quality fields, including CTD, NeeS & e-CTD, registration & launching/market access of pharmaceutical products/Cosmetics/MD/OTC/GSL/specialties in diversified regions (MENA, Levant, CIS, African Countries, Gulf Region, Asian Countries (ACTD), APAC & WHO dossiers) according to the guidance of each country.
I am dealing with awareness with WHO, ICH, FDA, Eudralex, EMEA, OMCL & ISO 17025 guidelines through real inspection audits from WHO, FDA, EMEA, DNDI, ISO 17025 & others. In addition, I performed GMP audits for API (ICH Q7 guideline) & Packaging manufacturers in China, India & Malaysia; and pre-inspection visits for pharmaceutical finished products companies in UK.
I am MBA holder; Certified Six Sigma Green belt (CSSGB) by IQF/USA and passing courses of Total Quality Management (TQM-P) and PMP (PMBOK V.5). I deliver training courses for Regulatory Affairs & Quality fields.
Currently I am the Regulatory Affairs Lead in Acino, based in Cairo Egypt, managing Gulf Eastern
Mediterranean (GEM) Region including 7 Countries (UAE, Kuwait, Bahrain, Oman, Qatar, Jordan,
Lebanon) and a team of 3.
I have more than 15 years experience in Regulatory Affairs in different region; GCC, Middle East, & North
I started my career in 2002 in Manufacturing Quality Assurance & Validation.
Then I have shifted to Regulatory Affairs since 2006 & I have been working among many local &
multinational companies such as Novartis & Pfizer until joining Acino in 2019.
“Heba Nabil is Regulatory Affairs Senior Manager for Egypt and Sudan- Pfizer Biopharmaceuticals Egypt.
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 when 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.”
Dr. Anwar is a professional business partner, with strong scientific & medical background, brings up 20 years of experience in the pharmaceutical industry.
Dr. Anwar obtained a bachelor’s degree in veterinary medicine and post graduate Microbiology diploma focusing on Immunology, Bacteriology, Virology and Mycology from Cairo University, Egypt.
Dr. Anwar started the career in 2001 as a medical representative in Egypt and then relocated to UAE in 2007, where she held several seniors roles in different top multinational pharmaceutical companies,” Novartis, GSK, Allergan and Abbvie”.
Dr. Anwar accomplished high level of business acumen with diversified roles in Medical affairs, clinical trials and Pharmacovigilance, within diversified geographical areas
Alex Juma Ismail, a pharmacist by profession currently working with the Tanzania Medicines and Medical Devices Authority (TMDA) within the Directorate of Medical Products Control under the section of Medicines Registration.
Within TMDA, he works as an assessor of quality, safety and efficacy of medicines and other medical products in the capacity of a Drug Registration Officer since 2017 and is serving as the focal person for the Southern African Development Community Medicines Regulatory Harmonization Programme (SADC-MRH) specifically the assessments unit and currently co-chairing the SADC Variations Technical Working Group.
PhArmacoVigilance Africa (PAVIA) coordinator- Eswatini. Alemayehu holds a bachelor’s degree in Pharmacy, a master’s degree in clinical research and currently pursuing his Ph.D. in pharmacovigilance and pharmacoepidemiology at the University of Bordeaux, France.
Rajappen is a Pharmacist, registered with the South African Pharmacy
Council, and has over two decades of extensive pharmaceutical
knowledge and experience in regulatory affairs, corporate affairs and
quality management practices. Kacy is a senior pharmaceutical
executive who is focussed, pragmatic, passionate and results driven.
Since 2007, Rajappen has been a Co-Founder and Director in KD
Consulting Pharmaceutical Solutions (KDC), a consultancy practice
supporting the needs of pharmaceutical, medical device, veterinary and
allied health companies in successfully delivering new products to markets and maintaining products inmarket. With her proven experience and track record within the industry, Rajappen has assisted companies
in developing filing strategies to facilitate registration of products in South Africa and Sub-Saharan Africa.
Rajappen’s intimate involvement within the pharmaceutical industry has allowed her to stay abreast of the
rapidly transitioning health care environment and strategically advise clients accordingly.
Since 2009, Rajappen is the Co-founder and Director of Umsebe Healthcare, a licensed South African
pharmaceutical company whose focus is on addressing the unmet medical needs of South African patients.
Rajappen is responsible and accountable for maintaining compliance of the Company’s product portfolio
and pipe line products, and ensuring quick access to market. Leading the company’s mid-long term plans
and strategy is top priority. Rajappen is also responsible for recruitment and developing the team to enable
high performance across all functions. With a vested interest in flattening the curve with the recent COVID19 pandemic, the company has collaborated with Thinking Crystal (Pty) Ltd, for the supply and distribution
of critical products required to manage the COVID-19 crisis.
Rajappen previously held the positions of Regulatory Affairs Departmental Manager and Medical Marketing
Manager at 3M Pharmaceuticals SA (Pty) Ltd (later known as iNova Pharmaceuticals). Rajappen was
responsible for ensuring the smooth, ethical functioning of the company by providing support for the
Marketing Department on Regulatory / Medical Strategic development, providing medical support to meet
business objective, participated in cross functional activities within the Division and responsible for
communicating and modelling management goals and values to assigned personnel. Rajappen also held the
position of Regulatory Affairs Pharmacist at Cipla-Medpro.
Some of the services that Rajappen is involved with across South Africa and Sub-Saharan Africa includes
amongst others: Regulatory consulting including Regulatory strategy development, Regulatory portfolio
management, Regulatory-Quality business management, Product registration and Registerability
Rajappen is registered with the South African Pharmacy Council, Pharmaceutical Society of South Africa and
the South African Pharmaceutical Regulatory Affairs Association and is a member of the Regulatory
Committee of the South African Medical Device Association (SAMED) and well as IPASA (Innovative
Pharmaceutical Association South Africa). KDC is registered with and is a member of the Heath Products
Experienced with a demonstrated history of working in the Pharmaceuticals & Medical devices industry. Skilled in Marketing Management, Business Planning, Sales, Market Research, and Management. Strong business development professional.
Poste actuel : Point Focal National de la Pharmacovigilance par décision N°723 MSHP-Centre National d’Appui à la lutte contre la Maladie du 09/09/2015, chargé de :
Recueillir et diffuser les informations sur les effets indésirables des médicaments
Analyser et évaluer le lien entre les produits de santé et les effets indésirables par l’imputabilité ;
Coordonner les activités de notifications au sein des structures et programmes de santé ;
Collecter les notifications d’effets indésirables des produits de santé provenant des professionnels de santé des secteurs public et privé des programmes de santé et de l’industrie pharmaceutique ;
Documenter et archiver les informations sur les effets indésirables des produits de santé dans une banque de santé ;
Faire le suivi et la retro information aux notifications des effets indésirables des produits de santé ;
Répondre aux demandes sur les effets indésirables des médicaments
Assurer les échanges avec le centre international de pharmacovigilance de l’OMS : UMC (Uppsala Monitoring center) ;
Programmer et réaliser des enquêtes de pharmacovigilance ;
Générer les signaux et alertes en matière de pharmacovigilance ;
Participation à la 24 ème session ordinaire du conseil d’administration du Centre National d’ Appui à la lutte contre la Maladie (CNAM) ;
Mission de supervision des activités du deuxième passage de la campagne de Chimio prévention du Paludisme Saisonnier chez les enfants de 3 à 59 mois dans le district sanitaire de Sélingue du 01-07 septembre 2016;
Mission de supervision formative de pharmacovigilance dans les districts sanitaires de Djenne et Bandiagara, Région de Mopti du 20 au 29 Novembre 2016.
Head of Regulatory Affairs – MENA in Hikma Pharmaceuticals (Amman – Jordan):
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 16 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:
- Member in the “Scientific Research Committee” during the scholar year 2019-2020.
- Member in the Faculty of Pharmacy board during the scholar year 2018 – 2019.
Jordan University of Science and Technology (JUST) & Yarmouk University:
- Deliver lectures to 5th year Pharmacy students on the application of certain concepts and technologies in the pharmaceutical industry, focusing on bridging the gap between theorical knowledge and practical application (started in 2017 till now).
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).
Qutaiba Al Manaseer, is a Public affairs professional drawing on more than 15 years’ experience in the biopharmaceutical industry. He is the Government Affairs Director for the Middle East and Africa, and he is leading the COVID vaccine supply project in AstraZeneca in this region.
Qutaiba serves in the Emirates Health Economics Society board as the Media and Public Relations Chairman.
Qutaiba holds an MBA from the Swiss Business School, Switzerland and a bachelor’s degree in Pharmacy from the University of Jordan. He is completing a master’s in health economics from Barcelona School of Management.
Before joining AZ, Qutaiba was the strategic market access and pricing lead for GSK Gulf.
Qutaiba is a strong advocate for Diversity and Inclusion, and he was the Global Development Lead in the Executive committee of the Women Leadership Initiative in GSK.
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.
Eman has a wealth of experience in PV since 2012; with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.
She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.
She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to be the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.
She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.
Diplômé en Médecine, le Professeur Riadh DAGHFOUS a reçu le titre de Médecin Résident Etranger des Hôpitaux de Paris et une Maitrise en Sciences biologiques en 1990, et a obtenu sa spécialité en Pharmacologie à l’Université de Tunis durant la même année et un Certificat d’études supérieures en statistique et épidémiologie en1995. Il a été nommé Assistant Hospitalo-Universitaire en Pharmacologie à la Faculté de Médecine de Tunis en 1991 puis Maître de Conférence Agrégé Hospitalo-Universitaire en 1996 et enfin Professeur Hospitalo-Universitaire en 2004.
Il a occupé plusieurs postes de responsabilité dont le poste de coordinateur de l’enseignement de la Pharmacologie à la Faculté de Médecine de Tunis (de 2002 à 2008) et chef de service de recueil et analyse des effets indésirables au Centre National de Pharmacovigilance (de 2007 à 2016) et a occupé la place de représentant tunisien auprès de l’OMS pour le réseau international de surveillance des vaccins pré-qualifiés.
Il est depuis Janvier 2017, Directeur Général Centre National du Pharmacovigilance.
le Professeur Riadh DAGHFOUS est président fondateur de la société tunisienne de pharmacovigilance, membre fondateur de l’African society of pharmacovigilance et membre de l’International society of pharmacovigilance.
I graduated from Clinical Pharmacy at the Addis Ababa University. I am currently finalizing my Master’s degree in Medicine Regulatory Affairs. I am an academcian at the School of Pharmacy, in the Department of Pharmaceutics and Social Pharmacy. I am the Co founder and Vice President of East Africa Regulatory Affairs Professionals Association. I work closely with the Ethiopian Food and Drug Authority (EFDA) in the medicine registration, inspection and PR departments. I also work as an external regulatory consultant for medicine registration.
Biography – Dr. Ahmed Hegazy
Dr. Ahmed Hegazy is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine
(First Class Honor), Mini MBA, Medical Quality Management Diploma and Hospital Management Diploma.
- He holds certificates on programs or courses from:
- The George Washington University, USA
- Columbia University, USA
- Royal College of Physicians, UK
- Hibernia College, Ireland
- Uppsala Monitoring Center, WHO
- He attended many trainings in leadership, strategic thinking, decision-making, brand planning, building efficient teams, high performance, accountability, communication skills, and persuasion and selling skills.
- Moreover, He attended courses in Outcome Research and Health Economics, Drug discovery and development, Medical Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
- Dr. Ahmed had been trained on ISO 9001-2015 Quality Lead Auditor Certification and Lean and Six Sigma Greenbelt Holder.
Dr. Ahmed received various awards and recognitions in innovation (Upjohn Award), achievements and others.
- He has scientific publications in international journals.
- Advisory Board, Committee member or member to International Scientific Journals, Associations and Conferences.
- He is a member of Emirates Medical Association
- He is a member of Emirates Health Economics Society
- He is a member of the ISoP society and was a committee member of the ISoP Middle East Chapter.
- He was invited as a speaker for hundreds of local, regional, international events and on TV as well as various online programs.
- He attended numerous (~100s) conferences and events.
He owns more than 25 years of wealthy experience in Pharmaceutical Industry in different regions and
functions (sales, training, medical, marketing and PV).
- He is an Expert in the Medical Affairs as he worked for 11 years in various positions in the Medical Affairs (Sr. Manager, Regional Manager and Head) in which he got experience in all MA roles, clinical research, governance, compliance, quality. He possesses strong medical knowledge in various therapeutic areas and many products’ portfolios. Currently, he conducts medical development programs.
- He was holding a position of Head of Global Patient Safety for Africa, Middle East, Turkey, Russia & CIS countries (82 countries) for 7 years in Merck in which he was managing more than 16 subordinates based in 8 different countries.
Currently he is a:
- Consultant for Medical Affairs, and Pharmacovigilance for Global, Regional and Local companies.
- Senior Auditor for an international EU-based firm.
- Speaker, Lecturer and Trainer for some colleges, companies, and health authorities.
Bio Ahmed Hegazy – June 2021
BECOME A PARTNER
BECOME A SPEAKER
INTERESTED IN ATTENDING
1. Help you comply with Good Pharmacovigilance Guidelines
2. Practical background
3. Focus on drug safety, risk management, regulatory and quality compliance
4. Support the build of Pharmacovigilance in more African countries
HANDS-ON ECTD COMPILATION AND PUBLISHING WORKSHOP
14-15 September 2021
In this hands-on workshop you will learn how to compile, publish, and validate an eCTD submission. In addition, participants will learn how to handle eCTD-specific requirements such as eCTD attributes, the regional envelope as well as lifecycle management and hyperlinks using practical examples.
Tim Ivanic, Professional Trainer, LORENZ Life Sciences Group