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
09:30-17:00 CET
Agenda
Pre-reading materials
- RECOMMENDATION PAPER ON DECENTRALISED ELEMENTS IN CLINICAL TRIALS
- Accelerating Clinical Trials in the EU (ACT EU)
- Report: 32nd Workshop of the EURORDIS Round Table of Companies (ERTC)
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.
Objectives
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.
Registration
ERTC members have received an email from Céline Schwob on 16th January with a link to register for the onsite or online event and access allocated passes.
To see the full list of ERTC members, please click here.
If you are not an ERTC member and wish to attend the workshop as an industry representative, please contact Céline Schwob celine.schwob@eurordis.org or Jo Marshall jo.marshall@eurordis.org.
For other attendees such as patient representatives, policy makers or healthcare professionals, please contact Martina Bergna martina.bergna@eurordis.org.
Venue
DoubleTree by Hilton Brussels City
Rue Gineste, 3
1210 Bruxelles
Belgium
Accommodation
Please make your own hotel reservations and travel arrangements.
Questions
Please send any questions concerning registration to Martina Bergna at: martina.bergna@eurordis.org
We look forward to welcoming you to the 35th EURORDIS Round Table of Companies.