PHARMACOVIGILANCE TRAINING AFRISUMMIT

Dr. Nesrine is a highly accomplished professional in the field of pharmacy, serving as the PharmD (Doctor of Pharmacy) in Charge of Vigilance at the Department of Technical Monitoring, Inspections, and Vigilance within the prestigious National Agency for Pharmaceutical Products of Algeria (ANPP).

With a solid educational background and extensive experience, Dr. Nesrine has become a trusted figure in the pharmaceutical industry. She holds a Doctor of Pharmacy degree, which reflects her deep understanding of the field and her dedication to improving the quality and safety of pharmaceutical products.

In her role at the ANPP, Dr. Nesrine is responsible for ensuring the safety and efficacy of pharmaceutical products within Algeria. She oversees the vigilant monitoring of technical processes, conducts thorough inspections, and enforces strict quality standards to guarantee the well-being of the Algerian population. Her work is instrumental in upholding the highest pharmaceutical standards and protecting the health of the nation.

Dr. Nesrine is known for her unwavering commitment to her profession and her strong sense of responsibility. Her dedication to her work is driven by a genuine desire to make a positive impact on healthcare in Algeria. Her expertise, attention to detail, and her leadership within the ANPP have earned her a reputation as a top professional in the field, inspiring trust and respect from colleagues and peers alike.

Outside of her professional life, Dr. Nesrine enjoys staying up-to-date with the latest developments in the pharmaceutical industry and is a passionate advocate for public health and safety. Her career continues to be marked by her relentless pursuit of excellence and her unwavering dedication to ensuring that the people of Algeria have access to the highest quality pharmaceutical products. Dr. Nesrine’s work serves as a testament to her commitment to the betterment of healthcare in Algeria and her enduring impact on the pharmaceutical industry.

Dr. Mukesh Dheda is the Director of the Pharmacovigilance Centre for Public Health Programmes based at the National Department of Health, South Africa. He obtained a B Pharm from the University of Durban Westville, an M Pharm from the University of Potchefstroom and a PhD from the University of KwaZulu Natal.

He has been instrumental in understanding pharmacovigilance (PV) in South Africa. He is involved in a number of policy, research and training initiatives which have grappled with the challenge of improving PV in South Africa. He has worked in the area of PV, both regulatory and public health PV, since the early 2000s. In his ongoing tenure as a registered pharmacist for almost forty years, Dr. Dheda has trained many pharmacists and interns, some directly under his supervision.

Libert Chirinda is a Chief Regulatory Officer in the Pharmacovigilance and Clinical Trials (PVCT) Division at the Medicines Control Authority of Zimbabwe (MCAZ), where he is involved in managing vigilance activities as well as clinical trials oversight activities.

He has ten (10) years’ experience in pharmacovigilance activities, clinical trial oversight, and medicines regulatory affairs, and has been part of the PVCT Division, which is also the National Pharmacovigilance Centre for Zimbabwe, since 2013. He has been involved in several pharmacovigilance initiatives locally, regionally, and internationally, and seeks to improve pharmacovigilance systems in Zimbabwe and beyond.

He is also a member of the Medical Research Council of Zimbabwe (MRCZ) National Health Research and Development Committee (NHRDC), which is involved in reviewing protocols submitted to the MRCZ for ethics approval.

He holds a Bachelor of Pharmacy Degree from the University of Zimbabwe (UZ), as well as a Master of Health Sciences Degree in Pharmacovigilance from the University of KwaZulu-Natal (UKZN).

Frieda works as a Medicines Information and Safety Pharmacist at the Therapeutic Information and Pharmacovigilance Center (TIPC) of the Namibia Medicines Regulatory Council (NMRC) since 2020. Prior to her role at NMRC, Frieda gained valuable experience at FabuPharm (Pty) Ltd in Namibia, where she held positions as a Regulatory Affairs Pharmacist and Production Manager. In her spare time, she works as a locum pharmacist in retail.

Apart from her primary roles, Frieda holds multiple leadership positions, currently serving as a member of the Pharmacy Council of Namibia. Within the council, she serves on both the Education and Preliminary Investigations Committees. Furthermore, she has recently been re-elected as the President of the Pharmaceutical Society of Namibia (PSN).

Frieda’s academic journey includes obtaining a Bachelor of Pharmacy (Honours) from the University of Namibia in 2016, followed by a Postgraduate Diploma in Health Information Systems Management from the Namibian University of Science and Technology. Her commitment to continuous learning is evident as she is presently engaged in specialized training, focusing on Dossier Assessment for Clinical Assessors in African regulatory agencies. Frieda’s efforts are driven by her passion for the pharmacy profession, and her diverse experience equips her to make substantial contributions across various healthcare roles, ultimately aiming to enhance healthcare systems in Namibia.

PhD Pharmaceutical Regulations
MBA General and Strategic Management
MSc PV and Pharmacoepidemiology

Has a long experience in the regulatory and inspection practice
As well as the community pharmacy and pharmaceutical services in Kuwait.
Currently, has research interest in the field of health economics and Pharmacoeconomics and the economic value of PV.

Pharm Uchenna Elemuwa is a Pharmacist and the Director of Pharmacovigilance, NAFDAC Nigeria. I have a Master’s Degree in Clinical Pharmacy and Bio pharmacy and another Master’s Degree in Industrial Labour and Relations. I am a Fellow of the West Africa Postgraduate College of Pharmacists.

Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food and Drugs Authority.

Adela is involved in the strengthening of the pharmacovigilance system in Ghana through education of stakeholders including healthcare professionals and the general public.

Adela’s recent works have been in assisting pharmaceutical companies in Ghana to establish efficient Pharmacovigilance systems through the training of Qualified Persons for Pharmacovigilance and the conduct of Good Pharmacovigilance Practice Inspections since 2016.

Judy has been in the pharmaceutical industry for over twenty years, initially specializing in research and development, progressing into investment; thereafter Regulatory Affairs, Government Affairs and Value, Access and Policy. Her career began with joining Mintek in 2003 after obtaining her PhD in Organic Chemistry at the University of Johannesburg (RAU). Judy started her research career in a secondment to University of Witwatersrand. During this time Judy went on a research visit to Heidelberg, Germany.  Shortly after her return to South Africa she began heading up the Mintek AuTEK Biomedical Programme, along with taking on an honorary position at the University of Witwatersrand.  At the end of 2012 Judy joined the Technology Innovation Agency (TIA), an entity of the Department of Science and Innovation (DSI), in Pretoria as the General Manager: Health. She was responsible for the oversight and leadership of the TIA Health sector team; the development and implementation of the Health sector strategy, the management and growth of the Health investment portfolio and the management of various stakeholder relationships throughout South Africa. Following TIA Judy moved to the Innovative Pharmaceutical Association South Africa (IPASA) in 2015.  Here Judy was responsible for monitoring trends, issues, problems, opportunities and activities in the healthcare environment, with a specific focus on Scientific, Regulatory and Government Affairs.  In 2018 Judy left IPASA to pursue private consulting.  During this time Judy was head hunted into the role of Executive Director for the Southern Gauteng Branch of the Pharmaceutical Society of South Africa (PSSA SG).  During her time at PSSA SG Judy was responsible for oversight of matters related to the Pharmacy Profession within the Branch, managing a conferencing facility associated with PSSA SG, and oversight of two investment companies.  At the end of 2019 Judy moved to Amgen South Africa as the Senior Manager for Regulatory and Government Affairs.  Early 2020 Judy’s role was expanded to include Value and Access (as a stretch assignment). In July 2022 Value and Access was moved to a dedicated lead. In her role at Amgen Judy was responsible for the registration and life cycle management of the Amgen South Africa product pipeline and portfolio, all matters related to Policy and Government Affairs, as well as Stakeholder management and the strategic direction of these core functions.  During this tenure Judy participated in various local and regional industry fora, and in many cases held the seat of Chair / Vice-Chair. Over Judy’s career she has engaged across multiple sectors including academia, government and the private sector.  In July 2023 Judy transitioned to Aspen Pharmacare.

Eduardo Jorge Monteiro Tavares has a degree in Pharmaceutical Sciences, a postgraduate degree in Evidence-Based Health and a master’s degree in Health Economics and Pharmacoeconomics.

In 2004 he joined the Dr. Agostinho Neto Central Hospital, as Director of Pharmaceutical Services.

In January 2007 he joined the Agency for the Regulation and Supervision of Pharmaceutical and Food Products (ARFA), as Head of the Operational Planning and Markets Division and, in 2011, he was promoted to Director of the Pharmaceutical Regulation Department, where he remained until July 2016.

At the same time, in 2009, he began his teaching activity at the Jean Piaget University of Cape Verde and later, in 2010, at the Intercontinental University of Cape Verde.

In July 2016, he was appointed to the position of General Director of Pharmacy at the Ministry of Health and Social Security, having dedicated himself exclusively to this role until May 2019, when he took office as President of the Board of Directors of the Regulatory Entity Independent of Health, position held to date.

He was a member of the ARFA Advisory Board, a member of the High Studies Commission of the Forum of Medicines Regulatory Agencies of Lusofonia (FARMED), a member of the Rapid Action Technical Team, the Oncology Commission, and the Hospital Infection Control Commission of the Ministry of Cape Verde Health.

He participated in the preparation of several studies and legislative proposals in the areas of regulating medicines and pharmaceutical products.

Dr. Abena is a pharmacist by profession with a master’s degree in clinical pharmacology. She has worked with the Food and Drugs Authority (FDA), Ghana for over 15 years and has been involved in the safety monitoring of marketed products in Ghana. She is currently the Head of the Risk Management Unit within the Safety Monitoring Department.

She has facilitated several training workshops focused on Medicine Safety. She has been instrumental in the monitoring of adverse events following immunization during the introduction of new vaccines in Ghana and is actively involved in the campaign of engaging patients in monitoring safety of their medicines. Abena has contributed to ensuring that pharmaceutical companies have established pharmacovigilance systems through training of Qualified Persons for Pharmacovigilance and conduct of Good Pharmacovigilance Practice inspections in Ghana.

Ms. Mwewa Mondwa Siame, is a Pharmacist with over 17 years’ experience, both in public and private practice.  She has worked for the Zambia Medicines Regulatory Authority (ZAMRA) for over 8 years now, most of which time has been under the Pharmacovigilance Unit at ZAMRA. She has helped spearhead and improve Pharmacovigilance in Zambia. Currently, she is the Principal Surveillance Officer heading the Vigilance and Clinical Trials Unit at ZAMRA. She is also a Master of Clinical Trials Candidate at the London School of Hygiene and Tropical Medicine (LSHTM).

An astute and forward-thinking Clinical Pharmacologist with 26 years of experience and a history of achievements in the regulation of clinical trials, pharmacovigilance, and post-marketing surveillance. Lead MCAZ PVCT department to obtain WHO Global Bench Marking Maturity level 3(ML3) on 27 August 2021 for Clinical Trials Regulation Oversight (CTO) and Vigilance Maturity Level (ML3) on 18th May 2023. Final year PhD student at University of Cape Town study PhD in public health vaccine safety active mHealth surveillance. The leadership in development of the Zimbabwe National Pharmacovigilance Center displays both my initiative and willingness to be involved, and the professional recognition that this body is required to meet international standards of practice. Proven experience is evident in consulting roles for PV, PMS, CTO and GCP inspections and successful management of several projects co-funded by regulatory partners such as WHO, UNICEF, Global Fund, Paul Ehrlich Institute (PEI), Vacci Train and Blood Train, and Global Health projects. This includes co-facilitation of several GCP, pharmacovigilance and trainings of setting up AEFI Committees in Africa at WHO and/or PEI organized workshops over the years. Awarded recognition as a WHO vaccine expert. I am an advisory member of the WHO African Vaccines Regulatory Forum (AVAREF) Technical Coordinating Committee and a WHO regulatory GCP and PV consultant who co-facilitated several PV and GCP courses in Africa.

Mafora is Pharmacovigilance Manager at South African Health Products Regulatory Authority (SAHPRA). She has 11 years’ experience in medicine regulation, 3 years as a Medicine Regulatory Officer within the Pharmaceutical and Analytical division and 8 years within pharmacovigilance. Mafora is a pharmacist with masters in pharmacovigilance and pharmacoepidemiology. She has attended different pharmacovigilance courses offered internationally including training by Uppsala Monitoring Centre.

She supports the National Immunisation Safety Expert Committee and is an active member of African Union Smart Safety Surveillance (AU-3S) Joint Signal Management Group (JSM) and Continental Safety Working Group (CWG), aimed at facilitating cross-country signal management for COVID-19 vaccines in Africa, to support action in the interest of public health and safety.

She previously worked in retail and hospital before joining medicine regulations.

BSc. Pharm. Cairo University, Egyptian Board of Healthcare Management. Ministry of health, Master of health care quality management Candidate-Arab Academy for science, technology and Maritime transport (AASTMT).

Manager of accreditation and development administration- General administration for pharmaceutical vigilance- Egyptian Drug Authority (EDA).

Previously work as Senior PV specialist in PSMF assessment unit then PV specialist in ICSR assessment unit.

Has work experience as inpatient hospital pharmacist, inspection team on community pharmacies, supply chain subunit in a governmental primary care, community pharmacy and pharmaceutical production area pharmacist supervisor.

Doaa Soliman is an Administrative Manager with 10 years of experience working within health care sector. Doaa specializes in pharmacovigilance and is responsible of Supervising and management of 3 units which are the PV training, PV inspection and PSMF assessment units.

• Participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
• Conducted PV inspection on pharmaceutical companies in Egypt.
• PSMF related Pitfalls specialized training sessions for pharmaceutical companies’ PV focal points in Egypt.

BSc. Pharm. Helwan University, Master of Business Administration (MBA) Candidate-Arab Academy for science, technology, and Maritime transport (AASTMT).

Deputy Manager of pharmaceutical vigilance.

General administration & Manager of Pre-Marketing Vigilance Regulatory Affairs Administration -General administration for pharmaceutical vigilance – Egyptian Drug Authority (EDA).

Previously Pharmacovigilance committee rapporteur & Senior PV specialist.

Walaa Ebrahim is an Administrative Manager with thirteen years of experience working within regulatory authorities. Walaa specializes in pharmacovigilance and is responsible of Supervising and management of Human, Biological, Herbal, Medical devices,  Veterinary & Biocides safety units, Supervising the development of policy proposals, Regulatory and executive regulations for pharmaceutical vigilance, Supervising the evaluation of risk-benefit balance and risk management plans for pharmaceutical products and for medical devices, Manage the Pharmacovigilance Committee and review the safety issues to be discussed by the Committee as appropriate.

• Actively participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
• Principle contribution in the issuance and reviewing of the updated guideline on pharmacovigilance practice in Egypt (GVP)
• Develop an appropriate Administrative & technical Manual on Pharmacovigilance practice regarding Human & Biological products illustrating the responsibilities of Marketing Authorization Holders.
• Conducted advanced-level pharmacovigilance training sessions for pharmaceutical companies and their respective teams.
• Participated in many EDA twining projects with other regulatory authorities.

She holds a BSc. Pharm. 2009, Master in Pharmacology, and toxicology Azhar University. 2018. She is the Deputy General Manager for post marketing pharmacovigilance and follow up – Egyptian Drug Authority (EDA).

Previously, she was a team leader of Cairo regional pharmacovigilance centre & Senior PV specialist. Maha Mohammed is an Administrative Manager with thirteen years of experience working in regulatory authority. Maha specializes in pharmacovigilance and is responsible of Supervising post marketing safety units, including ICSRs management unit, Signal detection unit, emerging safety issues unit, follow up unit and PRBER Unit.

Dr. Elirehema Mfinanga is an experienced public health physician with over 13 years of expertise in patient care; safety monitoring of medicines and vaccines; clinical development of vaccines and regulatory affairs. Currently serving as the national coordinator for the safety monitoring of vaccines and medicines at the Tanzania Medicines and Medical Devices Authority (TMDA). Dr. Mfinanga plays a crucial role in ensuring the safety and efficacy of medications and vaccines in Tanzania.

In his capacity as the national coordinator, Dr. Mfinanga is responsible for planning and coordinating all activities related to the safety monitoring of medicines and vaccines in Tanzania’s Mainland. He brings extensive knowledge and experience in developing pharmacovigilance systems, particularly tailored for the unique needs of developing countries. His expertise includes developing pharmacovigilance systems; assessment of Periodic Safety Update Reports (PSUR); Risk Management Plans (RMPs), Post-Authorization Safety Studies, and Pharmacovigilance Planning and Causality Assessment.

Driven by a deep passion for improved health outcomes, Dr. Mfinanga strives to make significant contributions to the advancement of health systems, leading to better health outcomes for communities in Tanzania and beyond. He holds a medical doctor’s degree from Muhimbili University of Health and Allied Sciences (MUHAS) and a MSC degree in Vaccinology and Pharmaceutical Clinical Development from Siena University in Italy.

With his diverse expertise and dedication to public health, Dr. Elirehema Mfinanga is at the forefront of ensuring the safety and efficacy of medicines and vaccines in Tanzania.

POSITIONS IN WAHO: Chairman Working Group on Information Management System to the WHO/World Bank/WAHO Medicines Regulation Harmonization project for West Africa.(2022-2024)

Member Technical Working Group on Information Management System to the WHO/World Bank/WAHO Medicines Regulation Harmonization project for West Africa (2018-2021)

OTHER POSITIONS: Member Technical working group on Traditional medicine Sierra Leone.

ACADEMIC QUALIFICATIONS

·        Foundation Fellow College of Pharmacy of the Sierra Leone Postgraduate Colleges of Health Specialties

·        Doctor of Pharmacy (ParmD) University of Benin Benin

City Nigeria

• Fellow West African Post Graduate College of Pharmacist
• Member West African Post Graduate College of Pharmacist
• Masters of Science Public Health Njala University
• (Hons) COMAHS

Training Courses Attended

• Two weeks training Course on Hospital Pharmacy Management Organized by PRASAO Cotonou Benin 7^th -18^th July 2008
• Three day training on Pharmacovigilance Organized by the Pharmacy Board of Sierra Leone in collaboration with the WHO and the University

of Ghana Kimbima Freetown 19^th -21^st  August 2008

• Five day Training course on Dossier Evaluation for Drug registration purposes organized by the Pharmacy Board of Sierra Leone Freetown 12^th -16^th January 2009
• Five day Training course on good manufacturing Practices (GMP) organized by the pharmacy Board Of Sierra Leone Freetown 19^th-23^rd January 2009
• Two weeks training Course on Pharmacovigilance Organized by the WHO Collaborating Centre on Drug safety Monitoring (Uppsala Monitoring Centre) Uppsala Sweden May25 -June 3 2009
• One week training on the conduct of therapeutic

efficacy study for antimalarials Accra Ghana June 2010

• Seminar on malaria control for Asian and African Countries Shangai china 17^th -30^th May 2011
• Effective communication in Pharmacovigilance 9^th – 14^th October, 2011 Accra Ghana.

• One day workshop on Pharmacovigilance for Biotherapeutic medicines Pre & Post Approval Settings Accra Ghana 11th September, 2015.

Lebogang has over 12 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 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.

As the Immediate Past 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.

He is the Division Manager for Pharmacovigilance and safety monitoring division at Rwanda Food and Drugs Authority (Rwanda FDA). He is a holder of bachelor’s degree in pharmacy from National University of Rwanda and master’s degree in Public Health Methodology from Université Libre de Bruxelles/Belgium. Currently, he Heads a division at Rwanda FDA that includes different regulatory functions mainly Pharmacovigilance, clinical trial oversight, Post marketing surveillance, promotion, and advertisement con trol.

He held different position in Health system in Rwanda including Deputy director of District Pharmacy and Chief Pharmacist at Bushenge Provincial Hospital for 5 years where he was focusing and dedicated in clinical Pharmacy practice, Quality Improvement, and supply chain management. He was involved in Pharmacovigilance harmonization process in East African Community. He was involved in establishment of different regulatory function at Rwanda FDA where He coordinated development of different regulations and guidelines especially these governing Pharmacovigilance, conduct of clinical trials, Post marketing surveillance, promotion, and advertisement of regulated products in Rwanda. He was involved in development of Hospital accreditation standards in Rwanda. He has different trainings especially trainings in pharmacovigilance, clinical trials, Translation medicines, Pharmacometrics, Assessment and registration of medical products.

George is a pharmacist by profession and had a Master degree in Public Health from the University of Ghana and a certificate in Pharmacovigilance and Pharmacoepidemiology from London School of Hygiene and Tropical Medicine. He is currently a PhD candidate at the University of Groningen where his thesis is focused on patients’ contribution to pharmacovigilance in Sub-Saharan Africa.

He is a Chief Regulatory Officer and the Head of the Safety Monitoring Department at the Food and Drugs Authority.

He has authored several abstracts and original research articles on medicine safety in peer reviewed journals.

George’s interest is in strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medicines and other health products.

I hold a Doctorate in Pharmacy from the Faculty of Medicine, Pharmacy, and Dentistry (FMPO) and a Master’s degree in Health Facility and Program Management from the Faculty of Economics and Management Sciences (FASEG).

Additionally, I have received training in the evaluation of drug Marketing Authorization Applications (MAAs) and the digitization of the healthcare system. Throughout my career, I have been involved in the digitization of the healthcare system, particularly in the digitalization of patients’ medical records, care pathways, and healthcare services in Senegal. I have also worked on situational analysis and problem-solving related to the dispensing and misuse of codeine-containing medications.

Currently, I am working at ARP, where I am involved in the implementation of a drug serialization system. I am also engaged in market control and surveillance activities.

Nadine Mouton, born in Windhoek, Namibia, is a dedicated and accomplished pharmacist. She spent her formative years in Windhoek, where her passion for healthcare and medicine began to flourish.

Nadine’s academic journey led her to the University of Namibia (UNAM), School of Pharmacy, where she pursued her studies in pharmacy.  Her dedication and hard work paid off when she earned her honours degree in pharmacy in 2019.  Following her graduation, she embarked on a one-year internship at Windhoek Central Hospital (WCH), solidifying her practical skills and gaining valuable experience in a clinical setting.

Currently, Nadine serves as a Medicines Information and Safety Pharmacist at the Therapeutics Information and Pharmacovigilance Centre (TIPC), which operates within the Namibia Medicines Regulatory Council (NMRC), under the Ministry of Health and Social Services (MoHSS).  In this role, she plays a pivotal part in ensuring the safe and effective use of medications, contributing to the overall well-being of the population.

Dr. Catherine Mwendwa Maina (Kenya) is a pharmacist with over 13 years’ of experience in the industry (community, hospital and industrial pharmacy). She is currently the Regulatory Affairs Lead East Africa & Sub regional LPVRP –Kenya at Glenmark Pharmaceuticals Ltd. She is keen on leadership, thrives in problem solving activities, takes pride when out of box thinking enables business growth and development.  She is involved in policy development and implementation of regulatory and quality assurance of medical products and health product technologies. An action-oriented member of the Pharmaceutical Society of Kenya. Her day to day includes MP/HPT submissions, LCM, AE/ADR/PQC reporting, PV related periodic submission, Oversight of PV function in selected countries, Business support and Regulatory intelligence.

Catherine holds a BPharm & MBA – International business from the University of Nairobi, Post Graduate Cert – BIRS and pursuing Master’s degree – BIRs (Biotechnology Innovation and Regulatory science) from Purdue University.

Dr. Andrea Julsing Keyter Has Over 15 Years Of Experience Within The Field Of Regulatory Affairs For Pharmaceuticals And Medical Devices, Regulatory System Strengthening, Quality Management And Production.

She Is A Pharmacist By Profession And Has Completed Her Phd In Regulatory Affairs At The University Of Hertfordshire In The UK In 2020.

She Worked For The South African Health Products Regulatory Authority As A GMP Inspector Followed By Her Role As The Head Of The Medical Device Unit. Prior To That She Worked In The Pharmaceutical Industry Both In Production And Quality Assurance. Dr Keyter Has Expert Knowledge And Experience In Regulatory System Strengthening And The Application Of Reliance Pathways For Enhanced Regulatory Performance.

She Has Participated As A Member And Chair Of A Number Of Committees Including PIC/S, The African Medicines Regulatory Harmonization And The African Medical Device Forum; And WHO-Led Working Groups Relating To Quality Management Systems For National Regulatory Authorities, HIV Self-Testing, Artificial Intelligence For Health, GBT For Medical Devices And Post-Market Surveillance.

In Her Current Capacity As A Technical Officer, Appointed In The WHO Regulatory System Strengthening Team, Dr Keyter Is Responsible For WHO-Led Benchmarking Activities, Providing Technical Assistance And Training To Member States And Is The Focal Point For The WHO Coalition Of Interest Parties (CIP) Network And The WHO Global Competency Framework.

Summary:

Dr Rania is the Patient Safety Lead at Roche Egypt affiliate for 4.5 years, with previous experience in the pharmaceutical industry since 2008 ranging between sales experience for five

years and Pharmacovigilance experience for more than nine years.

Additionally, she was appointed as a Risk Management Product Lead on rotation for one and a half years in the Roche Affiliate Global Interface team.

Dr Rania is also a member of the ISOP (International Society of Pharmacovigilance), Egypt Chapter.

Professional Experience:

Current Position:

Patient Safety Lead, Roche Egypt

Previous positions:

• RM Product Lead on rotation, Jan 2022- July 2023, Roche AGI team
• Global Safety Senior Associate, Amgen, Egypt Cluster (Egypt/ Iran/ Sudan) and Levant cluster (Lebanon/Jordan/ Iraq), April 2017-May 2019.
• Affiliate Safety Representative, AbbVie Egypt, May 2015-October 2016.
• Pharmacovigilance Specialist, Pharma-Tech, September 2014- May 2015.
• Senior Oncology Product Specialist, AstraZeneca Egypt for Pharmaceutical Industries, January 2013-November 2013.
• Oncology Product Specialist, AstraZeneca Egypt for Pharmaceutical Industries, September 2008-January 2013.

Associations:

Member of the ISOP Egypt Chapter, 2020- Present

Education

Bachelor of Pharmaceutical science – 2008, Alexandria University, Egypt

Certifications:

• Competency Accelerator Experience, Powered by the Live with Intent Pathway, Roche, September 2023
• Safety Risk Management Bootcamp, Roche, December 2021
• Pharmacovigilance Audit Training, Egyptian Pharmaceutical Vigilance Center, 16-17 February 2020
• Practical Guide to Writing Risk Management Plans, Management Forum, London, 28 Jan 2019
• Hands on Practice Pharmacovigilance training, Egypt Pharma Regulatory Conference, 17-18 October 2018
• Amgen Distributors’ day, Dubai, 2-4 October 2018.
• Pharmacovigilance training, GCC Pharma Regulatory Summit, Dubai, 12-13 March 2018.
• Affiliate Research workshop, Abbvie Germany, 1-2 June 2016.
• Principles of Good Clinical Practice Workshop, by ClinArt, Dubai, 16-18 May 2016.
• The Arab Africa Pharma Conference and workshops on Pharmacovigilance, 5-8 May 2016
• Onboarding Medical Training, AbbVie Paris, October 2015.
• Common Arab Pharmacovigilance Guidelines (Pharmacovigilance system and their quality systems, Pharmacovigilance System Master File, Pharmacovigilance audits and inspections), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, August 2015.
• Common Arab Pharmacovigilance Guidelines (Risk Management Plans and Risk Minimization Measures), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, April 2015.
• Common Arab Pharmacovigilance Guidelines (Periodic Safety Update Report), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, March 2015.
• Common Arab Pharmacovigilance Guidelines (Pharmacoepidemiology), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, January 2015.
• Common Arab Pharmacovigilance Guidelines (Post authorization safety studies, Signal management, Additional monitoring, Safety communication), by the Arab Union of the Manufacturers of Pharmaceuticals and Medical Appliances, December 2014.
• Dale Carnegie Training in Team Building, April 2013.
• Social Styles Training Course, 2012.
• TTM associates Training in Key Account Management, 2010.
• The Dale Carnegie Seminar in Effective Communications and Human Relations, June 2009.

Sarisha Naicker is an experienced and seasoned pharmacist skilled in Pharmacovigilance. She worked as a clinical research pharmacist for Setshaba Research Centre and the Aurum Institute.

In 2017, she completed the Uppsala Monitoring Centre Pharmacovigilance Training and has successfully established structure and process in the PV Systems at a few multinational companies.

She has overseen numerous PV audits and has been an invaluable member for the Medical Affairs department. Drug safety reporting is a critical function in pharma industry
and is integral in safety alerts and signal management.

He is a physician executive and medical epidemiologist with board certifications in pediatrics and medical informatics. Dr. Nordenberg’s career has focused on accelerating innovation at the intersection of digital health and science. Dr. Nordenberg serves as the Digital Transformation lead for the Safety Platform for Emergency Vaccines (SPEAC) program, funded by Coalition for Pandemic Innovation (CEPI), at the Brighton Collaboration and Task Force for Global Health.

Dr. Nordenberg is the Founder and CEO of Thriive.ai, a new population health company dedicated to safe medical technology. Thriive was awarded an Intel Innovations Fund grant for its COVID-19 Community Pandemic Response (CPR) Hub that enables community-based organizations to support their member’s health and wellness during a pandemic specifically addressing health disparities.

Dr. Nordenberg served as a member of the Health Information Technology Standards Federal Advisory Committee (US Health and Human Services) and the FDA’s National Evaluation System for Technology Planning Board. Dr. Nordenberg was a managing director in the health care practice of PwC; served as the Chief Information Officer (CIO) and Associate Director for the CDC’s National Center for Infectious Diseases where he was responsible for the information systems supporting infectious disease surveillance and outbreak response; he also served as an advisor in the Office of the National Coordinator for Health Information Technology at the Department of Health and Human Services (HHS). Dr. Nordenberg was a member of the Science and Technology Review Subcommittee of the Science Advisory Board of the FDA, 2007 and 2009, and delivered Congressional testimony on the 2007 report, FDA: Mission at Risk; founded and directed the Office of Medical Informatics at Egleston Children’s Hospital at Emory serving in one of the first chief medical information roles nationally. While at Emory, he was a co-principal investigator on the original Adverse Childhood Experiences (ACE) study that identified the linkage between abuse and adverse health outcomes.

Dr. Nordenberg received a BS in Microbiology from the University of Michigan, his medical degree from Northwestern University, completed his training in pediatrics at McGill University, Montreal Children’s Hospital, and his fellowship in epidemiology and public health in the Epidemic Intelligence Services (EIS) Program at the Centers for Disease Control with a focus on ‘big data’.

Dr. Nordenberg has lived and worked in many international settings over the past decades. He was one of the first international students in Mainland China and has worked on numerous initiatives in China.

She is a pharmacist, that graduated from University of Pharmacy in Tunisia and also holds a master’s degree in marketing Intelligence and Strategic Monitoring.

Prior to joining Bausch and Lomb, she worked for several companies in pharmacovigilance and regulatory affairs sectors (AbbVie, Novo Nordisk, and Sanofi Pasteur).

Ms. Hela also has regulatory experience with Novo Nordisk and Sanofi Pasteur for Tunisia and Libya.

Professor Ambrose O. Isah graduated from the University of Ibadan Medical School in 1979 and had his postgraduate training in Internal Medicine at the University of Benin Teaching Hospital, Nigeria. He had his postgraduate training in Clinical Pharmacology and Therapeutics at the Wolfson Unit of Clinical Pharmacology, University of Newcastle Upon Tyne, United Kingdom obtaining his doctorate degree (MD) in 1995. He is a Fellow of the National Postgraduate Medical College of Nigeria, the West African College of Physicians and the Royal College of Physicians, Edinburgh.

He is a Consultant Physician and Clinical Pharmacologist at the University of Benin Teaching Hospital, Benin City. Professor Isah has served on the academic staff of the University of Benin Medical School since 1989. He is a Past Dean of the Medical School; Past Head Department of Internal Medicine and pioneer Head of the Department of Clinical Pharmacology and Therapeutics. Professor Isah is the Pioneer Chairman of the Internal Medicine Subspecialty of Clinical Pharmacology and Therapeutics of the West African Postgraduate Medical College and Past Chairman of the Subspecialty of the National (Nigerian) College. He is the immediate Past Chairman of the National Essential Medicines/Drug Formulary Committee

Professor Isah played a key role in the establishment of the Pharmacovigilance system in Nigeria.  He is the current Chairman of the National Drug Safety Advisory Committee (NAFDAC; MOH) and Immediate Past Vice President of the African Society of Pharmacovigilance (ASoP).

Prof Isah was the Lead in the development of the WHO reference standards for the Drug Use Indicators as well as the WHO Pharmacovigilance Indicators.  He served as a member of the WHO Expert Panel and Advisor to the WHO Uppsala Monitoring Centre, Uppsala, Sweden. He was a Work Package Lead of PAVIA an EDCTP sponsored Pharmacovigilance Project in Africa

Prof. Isah is a recipient of the University of Ibadan Most Distinguished Alumnus Award 2021; a Fellow of the Nigerian Academy of Medicine; a Fellow of the British Pharmacological Society and a Fellow of the West African Society of Pharmacology. A keen lover of sports, documentary movies, he is married with three children.

19 experiences in pharmaceutical Industry

13 years’ experience as Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible, and as Quality Assurance Responsible Person

3 years’ experience as Consultant In RA & PV for local manufacturer in Jordan

Qualified International Trainer by International College in London

She is a senior researcher at the School of Public Health (SOPH), University of the Western Cape, South Africa. Hazel led the establishment of the area of specialisation in Pharmaceutical Public Health at the School, in collaboration with other colleagues from SOPH, the School of Pharmacy at UWC and Dr Raffaella Ravinetto, Institute of Tropical Medicine, Antwerp. This developing area of specialisation includes short courses, online modules and a research portfolio.

Hazel’s research interests include pharmaceutical human resources, using systems approaches to improve medicines quality, use and supply, and pharmaceutical public health education. She supervises several PhD and masters’ students in South Africa and other sub-Saharan countries. Hazel has contributed to several global reports for the International Pharmacy Federation (FIP) and the World Health Organisation and has provided academic support to Master’s and short courses for the University of Rwanda’s EAC Regional Centre of Excellence in Vaccines, Immunisation and Health Supply Chain Management and the Pan-American Health Organisation. She currently leads an EDCTP project (EU-funded) on Strengthening Pharmacovigilance and Regulatory Capacities in four Southern African countries (SPaRCS) and a project funded by Wellcome and the International Centre for Antimicrobial Resistance Solutions (ICARS) to develop Guidelines for Tackling AMR using Responsive Dialogues in LMICS.

Dr. Bassem Toeama graduated in medicine and has worked in clinical medicine as an oncologist, in academia, in the education and capacity building industry, and in the pharmaceutical industry over the past 25 years. His experience has been primarily in oncology, health economics and outcomes research, medical writing and scholarly communications, pharmacovigilance, clinical research, basic science research, continuous medical education, and continuous professional development. He holds an MSc degree in Experimental Therapeutics at the University of Oxford, UK, an MSc degree in Experimental Medicine at McGill University, Canada, and a PhD degree in health technology assessment at the University of Toronto, Canada.

Dr. Bassem is an experienced health economist, skillful medical writer, public health consultant at the WHO office in Cairo, Egypt, the CEO and Founder of MD Pharma Consulting Group Inc., and the Chief Research and Medical Officer at BeMe AI, Toronto, Canada. His areas of research are internal medicine, medical oncology, epidemiology, pharmacovigilance, health technology assessment, decision analysis, and benefit-risk assessment.

Pharmacovigilance Leader with Passion For Patient Safety with expertise In APAC, MEA, And Eurasian Region PV:

• 20+ years in pharmaceutical industry specializing in pv and clinical research.
• 15+ years of international pv leadership experience, coaching and empowering next-gen pv leaders.
• Proficiency in pre and post marketing pv regulatory requirements in apac, middle east, and Eurasian region.
• Proven expertise in building, developing, and executing pv qms, regional and affiliate pv governance model.
• Savvy in pv audits/ inspections and capa implementation.
• Track record of strong personal performance combined with demonstrated ability to build and lead a high performing team.

Laura Martin, PhD is the Vaccines Program Director, Global Health Technical Programs at the United States Pharmacopeial Convention (USP). Dr. Martin brings more than 20 years of increasing scientific and leadership responsibilities for the end-to-end development of vaccines of poverty-related disease in industry, government and academia, and a passion for global health.

In her role at USP, Dr. Martin leads the development and implementation of USP’s Global Health vaccine strategy to ensure access to quality-assured essential medical products.  Previously, Dr. Martin was responsible for portfolios of candidate vaccine projects including those combatting antimicrobial resistant bacteria and malaria.

Mr. Jean-Christophe Delumeau, a member of the Scientific Board of the International Society of Pharmacovigilance (ISoP), graduated in medicine and neuropharmacology from universities of Rennes and Sorbonne (Paris).

After medical residency, he completed a research program in intracellular signalling at the National Institute of Medical Research (Inserm, France), then moved to clinical research in healthcare companies based in Basel, Paris, and Tokyo where he conducted multinational trials in neurodegenerative diseases and cerebrovascular disorders.

From 2001 until June 2020, he exerted the responsibilities of regional pharmacovigilance leader at Bayer in Japan, China, and Singapore until his appointment as head of pharmacovigilance policy strategy with a global scope. On July 1st, 2022, Jean-Christophe Delumeau, was appointed as a board director of the Institute of Pharmacovigilance, the NGO developing the Global Pharmacovigilance Professional Certification in collaboration with ISoP.

Dr. Jayesh M. Pandit is the Pharmacovigilance Country Head (PVCH) and the Qualified Person for Pharmacovigilance (QPPV) Coordination Lead for Bayer Pharmaceuticals and Consumer Health in East Africa, based in Kenya and coordinates pharmacovigilance activities across North-West Africa (NWA) and East Africa country clusters. Before joining Bayer, Jayesh was the Head of the Medicines Information and Pharmacovigilance Division at the Pharmacy and Poisons Board- Kenya’s National Medicines Regulatory Authority, where he served for 10 years. Jayesh initiated and developed the National Pharmacovigilance System to ensure the quality, safety, and efficacy of medicines used in Kenya.

Jayesh has also served as the Secretary to the Expert Committee on Clinical Trials, has been a member of the Africa Vaccines Regulatory Forum (AVAREF), a member of various public health program- technical working groups (TWGs) as well as WHO’s team of consultants on Pharmacovigilance in Africa (Pharmacovigilante-Sans-Frontier).

With the vast experience that Jayesh has, he currently is an active member of the Pharmaceutical Society of Kenya (PSK), International Society of Pharmacovigilance (ISoP) and its Africa chapter and ISoP’s Special Interest Group on Eco Pharmacovigilance (EcoPV), among other professional groups. At the Kenya Association of Pharmaceutical Industries (KAPI), Jayesh, until recently, also Chaired the Pharmacovigilance and Medical Affairs Committee.

Comfort Ogar is a global safety consultant with the WHO on the novel oral polio type 2 vaccine (nOPV2). Prior to her work with the WHO, she was a Principal Technical Advisor and pharmacovigilance lead for the USAID funded Medicines, Technologies, and Pharmaceutical Services (MTaPS) program led by Management Sciences for Health, where she supported low- and middle-income countries in Africa and Asia to establish or strengthen their regulatory systems with particular focus on pharmacovigilance systems. She worked as a regulator for about 18 years at Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), where she was instrumental to establishing the country’s national pharmacovigilance system.

She has a master’s in public health (MPH) from The Hebrew University of Jerusalem, and a master’s in medical sciences (MMSc) in Global Health Delivery from the Harvard Medical School and is a PhD candidate at the University of Utrecht. Comfort is the current secretary of the Africa chapter of the International Society of Pharmacovigilance (ISoP). She is married with two children. She loves traveling and mountain biking.

Willemijn van der Spuij is Executive Director Europe in the WorldWide Patient Safety Organization in Bristol Myers Squibb. She is responsible for Patient Safety in the EU markets, Balkans and Baltics.

Prior to this role she was responsible for EU markets, PV Intelligence & International Operations including the PSMF as well as Training and Outsourcing activities.

Willemijn holds a Nursing Degree from the Netherlands, a BA (Hons) in Sociology from Goldsmiths college, University of London, UK and an MSc in Pharmacovigilance from the University of Hertfordshire, UK.

She is a member of the EFPIA Pharmacovigilance Expert Working Group and Chair of the EFPIA International Pharmacovigilance Group. Willemijn is also involved in external PSMF activities and Clinical Trial (PV) activities. She started her career in industry in Quintiles in Clinical Research and moved to Pharmacovigilance in Bristol Myers Squibb in 2003.

Willemijn lives in Switzerland with her husband and son.

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.
• 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.