CRED Clinical Development - Day 2

Learning Outcomes

 Understand the nature of safety (pharmacovigilance) and definitions associated with it  How the safety profile of drugs is determined during drug development  The monitoring of the safety of drugs during drug development and on the market  Understand some of the important regulations governing pharmacovigilance  How the safety of a drug is presented in product information (SmPC)

 What is a risk management plan

 Post-marketing pharmacovigilance regulations

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