Are you a company seeking to commission or collaborate in the conduct of a post-authorisation study (PAS)?

Do you wish to register a study in the EU PAS Register?

Are you considering applying for an ENCePP study seal?

Are you interested in the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals?

Review the list of signals discussed

ENCePP Plenary webinar registration is open to ENCePP Partners

The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP) will hold its virtual annual plenary meeting on 18 November 2021.

Registration is open to ENCePP Partners (centres and networks) until 26 October 2021.

Objectives of the meeting:

• To learn about key results from observational studies on Covid-19, methodological challenges that remain to be addressed, and how ENCePP could further promote best practice for Covid-19 research;

• To present the recently finalised CHMP Guideline on registry-based studies;

• To update on the work programme of the HMA-EMA Big Data Task Force and discuss the interface with ENCePP activities. Topics for discussion include the creation of curricula in Data Science, Pharmacoepidemiology and Biostatistics, the upgrading of the EU PAS Register and ENCePP Resources Database, an update on the Real-World Interrogation Network in the European Union (DARWIN EU) and the pilots for data analytics with EMA committees;

• To discuss the result of the surveys and agree on the amendments needed for the metadata and functionalities of the EU PAS Register and ENCePP Resources Database;

• To exchange views on the activities of the ENCePP Steering Group and Working Groups (WGs), the renewal of the WGs, and the proposed new ENCePP activities (e.g. new SIGs).

The event is for ENCePP Partners only, registration from other individuals will not be accepted.

The WebEx joining instructions will be sent to those ENCePP members who have registered via the below linked form.

Related information: Draft Agenda | Registration form

9^th Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology published

The 9^th annual Revision of the ENCePP Guide on Methodological Standards in Pharmacoepidemiology has been published. The Guide is maintained by the ENCePP Research Standards and Guidance working group under EMA’s coordination. The 9^th Revision has been extensively amended and re-organised with an improved structure. The foreword from the co-chairs of the ENCePP Steering Group highlights the importance of the Guide in the context of the COVID-19 pandemic and vaccination campaigns. Nearly all chapters contain relevant guidance on methodological standards to be used in COVID-19 studies, with references to selected publications illustrating relevant methodological aspects. This version will continue supporting sound pharmacoepidemiological research, including into COVID-19, and will provide a useful resource for clinicians, marketing authorisation holders and applicants, and regulators.