Pharmacovigilance
WORKSHOP ON DAY 2 (TUESDAY 6 JUNE 2023)
Morning session (4 hours)
Regulatory and Programmatic Pharmacovigilance systems in Africa
Course content
This training session will provide an overview of practical pharmacovigilance methodologies including detection and assessment of safety signals, risk management, and programmatic systems that have been used globally and in African settings to support robust collection, evaluation, and response to safety data on the performance of medicinal products. This interactive workshop will encourage discussion and brainstorming among participants to develop locally responsive approaches to pharmacovigilance.
Pharmacovigilance
WORKSHOP ON DAY 2 (TUESDAY 6 JUNE 2023)
Morning session (4 hours)
Regulatory and Programmatic Pharmacovigilance systems in Africa
Course content
This training session will provide an overview of practical pharmacovigilance methodologies including detection and assessment of safety signals, risk management, and programmatic systems that have been used globally and in African settings to support robust collection, evaluation, and response to safety data on the performance of medicinal products. This interactive workshop will encourage discussion and brainstorming among participants to develop locally responsive approaches to pharmacovigilance.
Ushma Mehta, Pharm.D, DrPH
Affiliation: Centre for Infectious Disease Epidemiology and Research (CIDER)Bio:Ushma Mehta has been practicing pharmacovigilance since 1996. She has been involved in regulatory pharmacovigilance, serving as the manager of the spontaneous reporting system in South Africa and more recently as a member of the SAHPRA Board. She has supported the development of pharmacovigilance systems for HIV, Malaria, Immunization and maternal and child health programmes across the globe. She is co-PI of the UBOMI BUHLE pregnancy exposure registry project which aims to monitor the safety of public health medicines (e.g. antiretrovirals) used in pregnancy. She is also a member of the WHO Advisory Committee on the Safety of Medicinal Products (AcSOMP).
Maribel Salas MD, MSc, DSc, FACP, FISPE
Dr. Salas is an Executive Medical Director, Therapeutic Area Lead of the Specialty Medicine, Clinical Safety and Pharmacovigilance Department at Daiichi Sankyo Inc. located in New Jersey, USA. She is a medical doctor with a specialty in Internal Medicine and epidemiologist with more than 20 years of experience in pharmacovigilance and pharmacoepidemiology. Dr. Salas holds degrees in Medicine, Internal Medicine, Outcomes Research, Epidemiology, Clinical Epidemiology, and Pharmacoepidemiology. She is the current president of the North American Society of Pharmacovigilance (NASoP), an ISoP Chapter, and an Adjunct Scholar at the University of Pennsylvania and at Rutgers University, USA. Dr. Salas worked in the Internal Medicine Department, Hospital of Specialties, and Preventive Medicine Department at the University of Alabama at Birmingham (UAB). She was a full-tenure professor at the School of Public Health (SOPH), UAB. She joined the Patient Safety Departments at AstraZeneca Pharmaceuticals followed by Pfizer Inc, Merck Research Laboratories, and lately, Daiichi Sankyo Inc. Dr. Salas has mentored fellows, MSc, and doctoral degree students of pharmacoepidemiology. Dr. Salas obtained various federal grants, worked with multiple large databases “big data” and “real-world data”, has published more than 100 scientific articles published in peer-reviewed journals, and has more than 1000 citations in the scientific literature.