CRED Understanding Clinical Development 2024

09/10/2024

CRED: Understanding the Clinical Development programme

Safety

October 2024

Jan Jepras- Pharmacovigilance Consultant

The Organisation for Professionals in Regulatory Affairs The Organisation for

Professionals i Regulatory Affairs

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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

The Organisation for Professionals in Regulatory Affairs

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