Generic and BioSimilar Medicines South Africa present a Workshop: 20 February 2020.

PHARMACOVIGILANCE IN A CHANGING WORLD

Presenters and Facilitators:

Dr Ushma Mehta and Associate Prof Karen Cohen

Date: Thursday 20 February 2020

Venue: Altron Bytes Conference Block C, 241 3rd Rd, Halfway Gardens, Midrand

Time: 09:00 - 16:00

DOWNLOAD REGISTRATION FORM HERE

Workshop Objectives

  1. To develop an understanding of the current local and global trends in pharmacovigilance and the evolving roles and responsibilities of the pharmaceutical industry in product and patient safety.

  2. To understand the scope of pharmacoepidemiological methods that can be used in post-marketing surveillance.

  3. To become aware of the pharmacovigilance research conducted in South Africa focusing on key findings relating to the burden and nature of drug-related morbidity and mortality in South Africa.

  4. To have an understanding of the current regulatory requirements for pharmacovigilance in South Africa

  5. To develop a practical appreciation for the factors that need to be considered when communicating the risk of harm associated with a medicine using real examples.

Who Should Attend?

  • Persons responsible for managing Pharmacovigilance typically Responsible Pharmacists and Medical Directors / Advisors

  • Members of the “Senior Management” who take overall responsibility

  • Regulatory Affairs Pharmacists

Expected Outcomes

  • Delegates will be given an insight into the Pharmacovigilance challenges and opportunities in the 21st century – reflecting on the evolving role of pharmaceutical manufacturers.

  • Delegates will be given an overview of the current regulatory requirements for Pharmacovigilance in South Africa.

  • Delegates will develop an understanding of the variety of pharmacoepidemiological approaches that have been used in pharmacovigilance research

  • Delegates will gain an understanding of recent pharmacovigilance research which provides valuable insights into the nature and burden of drug-related morbidity and mortality in South Africa.

  • Delegates will have the opportunity to engage with case studies of product safety issues focusing on factors that need to be considered when communicating the risk of harm associated with products to health professionals and consumers.

Topics covered

  • Pharmacovigilance opportunities and challenges in the 21st century

  • Beyond spontaneous reporting – a brief overview of pharmacoepidemiological approaches employed in pharmacovigilance

  • A review of pharmacovigilance research that sheds light on the nature and burden of drug-related morbidity and mortality in South Africa.

  • An overview of current regulatory requirements for pharmacovigilance in South Africa

  • Communicating risk – beyond package insert amendments –a workshop using case studies

About the Presenters

Dr Ushma Mehta: Ushma Mehta has been involved in pharmacovigilance and medicines regulation since 1996 initially in her role as manager of the Medicines Control Council’s National Adverse Drug Event Monitoring Centre. She has WHO in developing and auditing regulatory and programmatic pharmacovigilance systems in several countries. She co-ordinated the WHO Global Training Centre for Vaccine Safety from 1998-2007, supporting countries across the globe in strengthening their vaccine safety surveillance programmes. She currently serves as a Board member of the South African Health Product Regulatory Agency (SAHPRA) and previously served as chair of the MCC’s Pharmacovigilance Committee. She is a senior researcher at the Centre for Infectious Disease Epidemiology and Research at the University of Cape Town’s School of Public Health and Family Medicine involved in the pregnancy exposure registry project in the Western Cape.

Associate Professor Karen Cohen: Karen Cohen is a clinical pharmacologist and family physician in the Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, South Africa. She leads a drug safety research group. Her research interests include safety of antiretroviral and antitubercular medicines, programmatic pharmacovigilance strategies to inform policy, metabolic complications of antiretroviral drugs, drug induced liver injury and antiretroviral drug interactions. She is co-lead for the Southern African region of the African chapter of the International Society for Pharmacoepidemiology (ISPE).

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