Risk Management Information Day 2021

On 9 April 2021 the EMA announced a virtual event about risk management information will be held on 15 June 2021.

The focus of this Information Day will be an update of the Agency’s ongoing activities on medicines’ risk management with the opportunity for an interactive platform to exchange experiences between Regulators and Industry.

A dedicated session will focus on the extensive revision of GVP module XVI, with special attention on criteria for selection, development, and implementation of various risk minimisation measures (RMMs) supporting the optimal use of a medicinal product in clinical practice, at any time during its lifecycle.

Principles and methods to evaluate the effectiveness of these measures, as detailed in the newly introduced Addendum II of GVP module XVI, will also be presented, with practical examples of research strategies, challenges, and limitations.

An overview on the development of GVP module product - or population-specific considerations III: pregnant and breastfeeding women – will be provided, together with the key activities of the IMI ConcePTION consortium: ecosystem for evidence on the safety of medicines in pregnancy & breastfeeding.

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