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.
Click here for details: Call for Comments | Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum III - Pregnancy Prevention Programme and other Pregnancy-specific Risk Minimisation Measures
The deadline for comments is May 19.
The 14th ISPE Asian Conference on Pharmacoepidemiology invites expressions of interest for symposia topics and speakers in the area of pharmacoepidemiology and drug safety. A number of symposia will be accepted for inclusion in the program for ACPE14. These symposia will be programmed on either Saturday 22 October or Sunday 23 October 2022. Each symposium will be of strictly ninety minutes duration and can be expected to include multiple speakers whose contributions will be of interest to a substantial proportion of ACPE14 registrants.
Click here for details: Submit an ACPE 2022 Symposium Proposal
Symposia submission deadline: Friday 27 May 2022
Your safety at ICPE 2022 is our #1 priority. To meet this responsibility, we need your input on safety protocols for ICPE 2022 scheduled for Copenhagen in August. Our 5-min survey will gather your opinions on how ISPE should manage safety at the meeting venue.
Click Here for details: Take Our 5-min COVID-19 Safety Survey Today
The deadline to complete the survey is May 31.
ISPE members are invited to comment on the following manuscript "Considerations when Assessing Heterogeneity of Treatment Effect in Real-World Data" submitted for ISPE endorsement by the Real-World Evidence Task Force. 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.
Click here for details: Call for Comments | Considerations when Assessing Heterogeneity of Treatment Effect in Real-World Data
The deadline for comments is June 7.
View ICPE awards video here
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ISOP's 21st Annual meeting is scheduled for 20-23 Sept 2022 in Verona, Italy. More details at www.isop2022verona.org.
