The goal of the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is to facilitate independent and transparent post-authorization monitoring of medicinal products in Europe.
Before ENCePP, post-authorization studies requested by European regulators were often conducted in the US. ENCePP filled a need by creating a network to facilitate large observational studies and provide pharmacoepidemiologic best practices guidance in Europe.
A lot has happened in the ten years since the inception of ENCePP. Here’s what this European Medicines Agency-supported network has achieved so far:
- A strong scientific network supporting evaluation of medicines
- Better knowledge and accessibility of data sources
- Increased transparency for studies
- Better methods for studies
- Better governance for studies including management of interests.
Although the network’s member organizations are quite diverse, they have found a way of working together that has remained strong for ten years. That success has been credited to several things: a recognized need for guidance; a strong commitment to scientific transparency, independence, and quality; acknowledgment of the diversity of network contributors; strong governance; and face-to-face meetings.
RTI Health Solutions has been a member of ENCePP since its inception in 2007. Susana Perez-Gutthann, MD, PhD, Vice President, Global Head of Epidemiology at RTI-HS, served on its steering committee from 2012 to 2016. Alejandro Arana Navarro, MD, Senior Research Epidemiologist, is currently serving as chair of the Research Standards and Guidance working group.
Looking toward the future, ENCePP will need to be innovative in addressing current challenges such as data protection concerns, administrative issues, and a lack of resources. Given its success so far, we eagerly look forward to future collaboration made possible by this network.
Read the full article:
The ENCePP Steering Group. Strengthening standards, transparency, and collaboration to support medicine evaluation: ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) - Commentary. Pharmacoepidemiol Drug Saf. 2018 Jan 11;2018:1-8.