TEDDY involvement in the ENCePP activities focused on the EU PAS Register review

TEDDY involvement in the ENCePP activities focused on the EU PAS Register review

The European Union electronic Register of Post-Authorisation Studies (EU PAS Register) is a collection of non-interventional post-authorisation studies (PAS) and was launched in 2010 by ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance) to provide a free resource in Europe in the areas of pharmacoepidemiology and pharmacovigilance.

Currently, 1500 studies were registered in the EU PAS Register. The registration of studies is useful to reduce publication bias and promote information exchange as well as prevent unnecessary duplication of research.

The register is key to supporting transparency in post-authorisation research: by April 2019, 46% of the registered studies were requested by regulators, 10% were imposed as a condition of marketing authorisations (i.e. EU RMP category 1 and 2 studies) and 84% of those eligible had their protocol and abstract of results posted in the EU PAS Register.

The TEDDY WG- Information Technology and Data Science collaborates with ENCePP ad hoc WG (WG 3) to methodically review the studies posted in the register, that is increasingly used for academic research.  In particular, one out the objectives of ENCePP WG3 is to organise and implement a review of all studies registered in the EU PAS register including a description of the studies recorded therein with a special emphasis on the multiple database studies and the evaluation of their contribution to regulatory actions. TEDDY has been committed to reviewing 210 assigned EU PAS registered studies in which the paediatric population is concerned.

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July 26th, 2019|