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A medicine is authorized on the basis that its benefits outweigh its risks for the target population. However, not all potential or actual adverse reactions are identified by the time an initial marketing authorization is granted. The aim of risk management is to address uncertainties in the safety profile at different points in the lifecycle and to plan accordingly.
Marketing authorization applicants in the European Union (EU) are required to submit risk management plans, which include information on a medicine’s safety profile and plans for pharmacovigilance activities designed to gain greater knowledge. They also explain how risks will be minimized in patients and how those efforts will be measured.
To understand Risk Management systems in the European Union (EU) and hear about how to plan and write an EU Risk Management Plan.
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. Jan is experienced in all aspects of pharmacovigilance but specialises 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.