The responsibilities for all stakeholders involved are set out in GVP Module XVI for Risk Minimisation . It is important to ensure that additional risk minimisation measures, including assessment of their effectiveness, do not introduce undue burden on the healthcare delivery system, the marketing authorisation holders, the regulators, and, most importantly, on the patients. The necessity to have a clearly defined objective in order to minimise risks and/or optimise the risk-benefit balance is becoming increasingly important.
SMi's masterclass hosted by Oxon Epidemiology will provide delegates the opportunity to learn about risk minimisation studies, their implementation and evaluation in Europe from two EMA experts: a regulator from the EMA PRAC committee and a clinical Pharmacoepidemiologist at ENCePP.
Why you should attend:
Discuss your challenges in risk minimisation
Evaluate effectiveness of planned and ongoing risk minimisation
Learn from real-life case studies and exercises
Analyse the principles of risk management
Increase effective alignment of risk studies and regulators
Gain insights into the benefits of using an evidence-based toolkit
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