Deadline: EOB Thursday, 19 May
The European Medicines Agency (EMA) has published for public consultation a "Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures". This new guidance defines the elements of a pregnancy prevention program and provides for deciding when such program is needed or other risk minimization measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

ISPE's Medications in Pregnancy & Lactation (MiPaL) SIG has prepared comments for submission as ISPE's official response to EMA's public consultation and ISPE members are invited to review and comment on the draft response. The response deadline for member comments is EOB Thursday 19 May.
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The posting for member comments is consistent with Section 1.7.1 Endorsement of documents as ISPE Public Policy (see ISPE Policy Manual); the Public Policy Committee has approved this call for member comments.

At the conclusion of the comments period, feedback will be provided to the authors, who will thereafter prepare an updated paper for ISPE Board review and endorsement. The final paper will be posted to the ISPE website and shared with members.
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