An Egyptian Pharmacist with 6-year- experience in PV working in different companies ensuring the patients’ safety in various regions (Egypt, Gulf and Levant).
Currently, the LSR back-up in Roche Egypt for the past 4 years and the former LSR in Roche Gulf for 2.4 years.
Before joining Roche, Nour has worked in Bayer PV department covering the Middle East.
PV Hub partner in Dubai Pharmacovigilance (PV) Hub with over 8 years of experience in Pharmacovigilance. Currently the Hubs Submissions champion and Automation Champion.
Career: Medical representative (Roche Nigeria); Medical tourism (Dubai UAE), Pharmacovigilance and drug safety (Roche Dubai, UAE)
Driving process improvement to achieve efficiency and better ways of working is my ethos.
She is responsible for the implementation and maintenance of an effective local pharmacovigilance system for the respective affiliates, the development and implementation of the local Patient Safety strategy, ensuring active contribution, partnership with local and global stakeholders.
She is a Medical Doctor graduated from Faculté de Médecine de Tunis. She joined Roche in 2012 as Clinical Trials Manager with full accountability for all the assigned studies at country level.
She worked in different positions with increasing responsibilities in Clinical Research in diverse therapeutic areas, Safety, Quality management and Medical Affairs for Tunisia and Libya. She has a strong passion to create value and sustainable impact on the ecosystem.
Max Goldberg leads the global medical device reporting team for Worldwide Patient Safety at BMS. He holds a bachelors and master’s degree in engineering and has expertise in medical devices and combination products throughout the entire product lifecycle. Max has been involved in product development, risk management, manufacturing, and post market surveillance for medical devices, combination products, and biologics. He is involved in forming and implementing global combination product post market safety reporting regulation.
Pr Nadjat LOUMI-MEDEDJEL, Director of the Centre National de Pharmacovigilance et de Materiovigilance (CNPM), is a doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon (France).
She took part in the creation of the CNPM with its founder Professor A Helali in 1998, whereshe has always been devoted to pharmacovigilance and materiovigilance.
Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medicaldevice and the vaccine alreadyestablished.
Teacherat the Faculty of Medicine of Algiers, wheresheteaches the module of pharmacology. She supervises the training of resident physicians in clinical pharmacology.
She supervises also the training of health professional in :
“Pharmacovigilance and Materiovigilance” ; “Medical good prescribing” ; “Monitoring plasmatic of medicine” ; “Rational drug use program”.
She is Editor of the independent Medical journal “la Revue Prescrire” since 2007.
Dr. Amira Amin received her Bachelor degree of pharmaceutical science. faculty of pharmacy, Cairo University in 2006 and Diploma in clinical pharmacy from faculty of pharmacy (Ain-Shams university) in 2010.
Today she is the deputy head of Egyptian pharmaceutical vigilance administration at Egyptian Drug Authority since September 2020 and joined from pharmacovigilance specialist at Egyptian pharmacovigilance center (EPVC) – (CAPA) – Ministry of health (MOH) where she honed her skills for 6 years.
She is an American board certified for pharmacotherapy specialty, she has two master degrees, one in clinical. pharmacotherapy and the second in public Administration from the American University in Cairo.
She is a fellow at the Egyptian board for healthcare management. She has profound working history in regulating pharmaceutical practices in the Egyptian public and private sectors, she used to be managing the PV General administration for more than 2 years, supporting the additionally, she represents the Egyptian drug authority as an Observer at the international cooperation on cosmetic regulations working group ICCR. Previously, she used to be the antimicrobial stewardship national coordinator and participated in the development of the National Action Plan for Antimicrobial Resistance.
Brève présentation : Pharmacien, marié et père de trois enfants. J’ai treize (15) ans d’expérience professionnelle dont dix (10) ans dans le domaine de la réglementation et de la régulation pharmaceutique. Je suis dans l’amélioration continue du travail et j’ai une bonne capacité d’adaptation. Mes objectifs professionnels : Acquerir une excellente compétence dans la régulation pharmaceutique et Partager ces connaissances acquises en tant qu’expert.
She is a pharmacist by training. She has specialized in Pharmacoepidemiology and Pharmacovigilance, currently enrolled for PHD studies in Clinical Pharmacology and Pharmacovigilance at Karolinska Institutet in Sweden focusing on strengthening safety monitoring in public health programs with a focus on mass drug administration.
She is the Head of Pharmacovigilance at the Pharmacy and Poisons Board, Kenya, and the Vice President of International Society of Pharmacovigilance, Africa Chapter. She has 15 years working experience in Pharmacovigilance related work and is responsible for leading the PV team in Kenya to develop regulatory systems to strength Pharmacovigilance within the health sector and pharmaceutical industry.
She is a member of the Pharmacovigilance and PMS technical working groups in Kenya, within the East African Community and The Intergovernmental Authority on Development Regional Economic Blocks and has contributed to development of various tools and guidelines for strengthening of PV in the region. Recently appointed as a member of the AMRH Technical Committee on Regulatory Capacity Development in Africa (ToR RCD)
She is passionate about patient safety and keen on strengthening pharmacovigilance systems and patients’ contribution to safety monitoring of medical products and health technologies, she is also keen in contributing to a pool of trained PV specialists in Kenya and gives honorary lecturers to both undergraduate and masters students at University of Nairobi.
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.
