CRED Understanding Clinical Development 2024

09/10/2024

Post-marketing pharmacovigilance

• USA • Federal regulations with some guidance documents • Japan • PMDA has its own guidances including good post-marketing surveillance practice

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes: Recap

⚫ What is pharmacovigilance and some of the definitions associated with it

⚫ Data collected to determine the safety profile of drugs during drug development

⚫ The monitoring of the safety of drugs including safety data reporting to regulators during drug development and on the market

⚫ Understand some of the important regulations governing development pharmacovigilance and differences in different geographies

⚫ Guidance on how the safety profile of a drug is presented in product information (SmPC)

⚫ Introduction to a risk management plan and PASS

⚫ How to obtain information on EU post-marketing pharmacovigilance regulations

The Organisation for Professionals in Regulatory Affairs

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