An Introduction to Pharmacovigilance
Jan Jepras is a pharmacovigilance consultant with over 20 years experience of drug safety across all phases of drug development. Jan was a Pharmacovigilance Manager at GSK between 1999 and 2010 and has been an independent consultant since then working with a variety of clients both big and small including Takeda, Public Health England, The Department of Health, Pharmora, AstraZeneca, Centus Biotherapeutics, Immune System Key and Amgen. Jan is experienced in all aspects of pharmacovigilance but specializes in pharmacovigilance writing such as global drug registration submissions, risk management plans, periodic reporting, signal detection, and evaluation and training. Jan is a Fellow of The Pharmaceutical Information and Pharmacovigilance Association and lectures on Pharmacovigilance on the MSc course in Pharmaceutical Medicine at the University of Surrey.
Also known as drug safety, pharmacovigilance has evolved extensively since the story of thalidomide in the 1950s when there was very little regulation around the safety of medicines, and as a science, it is still evolving today.
There is now comprehensive regulation around the safety of medicines globally and marketing authorization holders have extensive responsibilities in this area for drugs both in clinical trials and post-marketing.
The presentation will provide an introduction to pharmacovigilance, covering both the historical aspects of pharmacovigilance and some of the latest developments. Terminology and key concepts will be covered with examples of how pharmacovigilance fits into the life cycle of a drug.
The regulatory requirements of marketing authorization holders will be covered both for clinical trials and post-marketing with an introduction to the processes and activities conducted to ensure the safety of patients.
- The history of Pharmacovigilance
- Definitions and terminology
- An introduction to the Regulations around pharmacovigilance
- An introduction to pharmacovigilance in clinical trials and post-marketing
Course Level - Basic
Who Should Attend
- Those new to pharmacovigilance or thinking of moving into the area of pharmacovigilance
- Pharmacovigilance administrators
- Those working in clinical or regulatory who require some pharmacovigilance knowledge
Why Should Attend
Over recent years there has been an increasing public awareness of safety issues relating to medicinal products. The recognition of the importance of pharmacovigilance has also grown over the last few years as both regulatory authorities and pharmaceutical companies seek to ensure that emerging safety information is reported, and appropriate action is taken to safeguard public health.
No effective medicine is without risk. Pharmacovigilance is about identifying that risk and managing it in an appropriate way to ensure the safety of patients.
There is now comprehensive regulation around the safety of medicines globally and marketing authorization holders have extensive responsibilities in this area for the medicines they are developing and selling. The presentation will cover these key responsibilities and show what companies need to do to remain compliant in this area and to ensure the safety of patients taking their medicines.
Pharmacovigilance is the science and activities relating to the collection, detection, evaluation, and prevention of adverse effects or other drug-related problems.