EMA Risk Management Information Day

This in-person information day will provide an overview of key developments in EU pharmacovigilance guidance related to the safe use of medicines during pregnancy and breastfeeding as well as updates in GVP Module V Risk Management Plans and GVP Module VIII Post authorisation safety studies (PASS).

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What’s New: PASS and Risk Management Plan Updates

Speaker(s)

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands

GVP Module V – Updates to Risk Management Plans: Forward-Looking Regulatory Developments

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EMA Risk Management Information Day

What’s New: PASS and Risk Management Plan Updates

Speaker(s)

Emil Andrei Cochino, MD, MHS

Be informed and stay engaged.