Teamit Institute has formed a strategic partnership with Utrecht University to streamline the European Pharmacoepidemiology & Pharmacovigilance (EU PE&PV) Network management and enhance coordination, particularly for upcoming EMA tenders. This collaboration is set to boost efficiency and foster stronger cooperation in pharmaceutical research across Europe.
The EU PE&PV Research Network is committed to advancing the understanding of the real-world effectiveness and safety of medicines and assessing the impact of regulatory interventions. Spanning over 50 research centers in 21 European countries, the network offers a solid foundation for international research initiatives.
Coordinated by the Division of Pharmacoepidemiology & Clinical Pharmacology at the Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, the network operates as a public academic partnership. It benefits from the guidance of eight prominent research centers across Europe, ensuring high standards of scientific excellence.
Since its inception in 2015, the EU PE&PV Research Network has completed 12 projects across various therapeutic areas, demonstrating its extensive expertise and dedication to advancing public health. Each research project is managed by a dedicated consortium of centers across Europe, with all projects registered in the HMA-EMA Catalogues of real-world data sources and studies, ensuring transparency and accessibility.
Teamit’s Role: Driving Effective Project Management
Teamit Institute plays a critical role in supporting the EU PE&PV Network through key responsibilities, including:
- Communications: Managing both internal and external communication, from newsletters and EMA queries to updating the HMA-EMA Real World Data (RWD) Catalogue.
- Network Management: Maintaining contact lists, addressing member queries, and sharing updates to promote collaboration within the network.
- Tender Support: Assisting with tender scope evaluation, proposal development, and leading communications with the EMA to ensure successful submissions.
- Procurement Support: Facilitating activities related to a new Framework contract with the European Medicines Agency (EMA).
Support for EMA-Funded Projects
In the event of successful EMA project bids, Teamit will provide comprehensive support, including:
- Efficient Coordination: Ensuring smooth communication between the EMA and consortium members.
- Budget Oversight: Monitoring budgets and liaising with contractors.
- Administrative Services: Overseeing deliverables, ensuring compliance, and tracking study registration in the EMA-HMA catalogue.
A Strategic Step Forward in Research
This partnership highlights a commitment to improving research coordination, paving the way for the successful execution of future EMA-funded projects. By combining their expertise, the EU PE&PV Network and Teamit Institute aim to support methodological advancements in pharmacoepidemiology and pharmacovigilance and best RWE generation for regulatory decision-making.