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Januar 2023

35th Workshop of the EURORDIS Round Table of Companies (ERTC)

Bringing Clinical Trials into the Future

Wednesday, 22nd February 2023 – Doubletree by Hilton Brussels City in Brussels and online


Programme and Concept Note

Workshop description

EURORDIS-Rare Diseases Europe, along with the broader community of patient organisations, have been on a journey to shape the European policy landscape to bring more and better treatments for rare disease patients. From advocating for the EU Regulation on orphan medicinal products (1997) to the EU Directive on Patients’ Right to Cross-Border Healthcare (2011), the rare disease community has continued to lead collective efforts towards the adoption of legislations impacting lives.

Another case in point is the evolution of the Clinical Trials Regulation, which will profoundly change the way trials are conducted in Europe and improve further healthcare delivery pathways for rare disease patients. This workshop is set to evaluate the potential and ambition of this legislation and its implementation, one year after it came into effect in Europe, and to appreciate the benefits and challenges of this new approach to clinical practice for developers, patients and regulators.


This workshop will provide participants with valuable information on the following points:

  • Get insights into the European legislative environment that is shaping clinical trials. Bringing Clinical Trials into the Future;
  • Explore the strategy for Accelerating Clinical Trials in the EU (ACT-EU) and better appreciate which political actions are taken towards reaching this goal;
  • Learn about key public initiatives and public-private partnerships that are contributing to the ACT-EU objectives in developing and implementing innovative approaches to clinical trials;
  • Understand which guidelines and recommendations are being developed to inform clinical trial practice as it evolves (e.g. recommendations for decentralized trials, ICH guidelines for clinical trials, etc);
  • Discuss how rare disease patients will benefit from advancements in clinical trials;
  • Contribute to building collective knowledge by sharing your experiences and challenges throughout the day alongside peers.


Please send any questions concerning registration to Martina Bergna