Dr. Judy Coates

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.

 

MS. COMFORT KUNAK OGAR

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.

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.
  • 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.

 

DR. JAYESH M. PANDIT

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.

 

MS. WILLEMIJN VAN DER SPUIJ

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.