Dr Seema Jaitly, Managing Director, Essjay Solutions, recently presented at the popular Back to Basics Pharmacovigilance course run by the Drug Safety Research Unit.

A large number of delegates attended the course and heard the presentations on International Collaboration in Pharmacovigilance. The objectives were to give attendees an understanding of the need for global pharmacovigilance and in particular for standardisation of collection and monitoring of data and the principles of risk:benefit analysis.

Dr Jaitly covered the relevant CIOMS working group outputs and ICH guidelines that have become the backbone of pharmacovigilance activities in today’s world. This included ICSR management, aggregate reports including PSURs/PBRERS/DSURs, core data sheet development, risk management planning, risk minimisation, clinical safety, and signal detection. Dr Jaitly focussed on the key points of the guidelines and how these have been implemented globally, highlighting key differences that are important to understand in the global workplace.

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