Paul-Ehrlich-Institut
Paul-Ehrlich-Institut
10/30/2023 | News release | Distributed by Public on 10/30/2023 09:38
Annual Exchange between the Paul-Ehrlich-Institut and the Association of Research-Based Pharmaceutical Companies (vfa)
Annual Exchange between the Paul-Ehrlich-Institut and the Association of Research-Based Pharmaceutical Companies (vfa)
The annual meeting between the Paul-Ehrlich-Institut (PEI) and the Association of Research-Based Pharmaceutical Companies (Verband forschender Arzneimittelhersteller, vfa) took place on 30 October 2023. The event provided an opportunity for an in-depth exchange on current developments and challenges in the research and development of medicinal products. This year's agenda focused in particular on issues relating to the European harmonisation of regulatory procedures for medicinal product development and authorisation.
The Vice President of the Paul-Ehrlich-Institut, Professor Stefan Vieths, kicked off the discussions with an overview of the authorisation and advisory procedures for medicinal products for which the Paul-Ehrlich-Institut provides support. He also presented information on progress that has been made in three ongoing artificial intelligence (AI) projects at the Paul-Ehrlich-Institut and on preparations for the anticipated designation of the Paul-Ehrlich-Institut as an EU reference laboratory in accordance with the IVD Regulation (EU) No. 2007/746.
Focus: Exchange on European Harmonisation
The experts exchanged views on the current state of European harmonisation of regulatory procedures for the development, authorisation and pharmacovigilance of vaccines and biomedicines. They discussed topics such as the digital distribution of Dear Doctor letters (Rote-Hand-Briefe), the European regulation on in vitro diagnostic medical devices, and the improvements in the efficiency and transparency of clinical trials in Europe that use of the Clinical Trials Information System (CTIS) is hoped to bring about. The agenda also included the European "Health Technology Assessment", the EUHTA for short, which is generally understood as an assessment of the added value of medical procedures and technologies with regard to their effects on healthcare in the EU.
Annual Meeting Remains an Important Platform for Dialogue
The strong mutual interest in this now firmly established exchange of experience and information shows how important the continuous knowledge transfer between regulatory authorities and the pharmaceutical industry is for the quality, effectiveness, and accessibility of vaccines and biomedicines. Such an exchange helps to ensure that patients have the best possible access to necessary, but also innovative medicines and thus to promote the health of the population.
Updated: 30.10.2023