TOPRA Symposium 2020 - The evolving world of Regulatory Affairs: innovate regulation or regulate innovation?

date: 29/09/2020

How can health authorities such as the Federal Agency for Medicines and Health Products (FAMHP) and the European Medicines Agency (EMA), in collaboration with all stakeholders, regulate innovative medicines and health products and innovate regulations? Find out all about it at the 17th TOPRA symposium, where innovation is central and which will take place from 5 to 8 October 2020. This symposium is organized in collaboration with the FAMHP.

For whom?
Regulatory affairs managers of companies and SMEs active in the healthcare sector, sponsors of clinical trials of medicines and health products, patients and patient associations, academic researchers, healthcare professionals, representatives of health authorities, etc.

The main themes

  • The future and innovation of the regulatory system in healthcare and the European network strategy
  • Regulation and innovation at the border between medicines, medical devices and in vitro diagnostics (IVDs)
  • Patient-oriented clinical research and regulatory system
  • Implementation of the new European Veterinary Medicines Regulation (NVR)
  • Implementation of the new European Regulation for medical devices (MDR) and in vitro diagnostics (IVDR)
  • Support on regulatory aspects and innovation for SMEs and academic research centres
  • Scientific-technical and regulatory advice (STA)
  • Advanced therapy medicinal products (ATMPs)

Practical information
September 29, 2020, in the afternoon: pre-event and opening presentation
5 to 8 October 2020: online symposium

More information and the final programme

Registration is possible until October 1, 2020

The live presentations will be recorded and will be available through the online platform for three months after the event. Registered participants already have access to the online platform.

Last updated on 29/09/2020