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PV Hot Topics

Draft GVP Module XVI on RMMs

The EMA has launched a public consultation on the third revision of Module XVI on “Risk Minimisation Measures -Selection of tools and effectiveness indicators” and its new Addendum II on “Methods for effectiveness evaluation”.

EMA CTIS Training

In preparation for the implementation of the new EU Clinical Trial Regulation at the end of 2021, the EMA has initiated a range of training activities on the EU Clinical Trials Information System (CTIS).

Post-Brexit Guidance

Following the end of the Brexit transition period on 31-Dec-2020, the MHRA has published additional information on the new requirements for UK MAHs, including updated guidance and video recordings of associated webinars.

Canada ADR Reporting guidance

Health Canada has announced a new consultation on a draft revision to the Guidance on “Reporting adverse reactions to marketed health products”, which is intended to clarify existing reporting requirements.

Hot topics are taken from Safety Observer Lite Feb 2021