32nd EURORDIS Round Table of Companies Workshop

The impact of the EU regulatory network strategy 2020-2025 on the development of orphan medicines

ONLINE

20-21 October 2021

14.00-18.00 CET

 

Workshop Description

The European Medicines Agencies Network Strategy to 2025 and  Regulatory Science Strategy to 2025 are forming a comprehensive approach to plan and prepare for the future. This includes preparing the EU regulatory network for the next generation of regulatory activities. In order to do this, four EMA Task Forces have been created on: Digital Business Transformation, Data Analytics and Methods, Regulatory Science & Innovation and Clinical Studies and Manufacturing.

The 32nd EURORDIS Round Table of Companies Workshop will place a strong emphasis on exploring and discussing elements of these task forces, and their impact and importance for developers of rare disease treatments.

This is your opportunity to join us to discuss and gain insights into new methods to analyse data, new sources of data and changes in the way new Clinical Trials are conducted.

Objectives

This workshop will provide valuable information to its participants with the following objectives:

  • Get insights into the future of the regulatory strategy for data acquisition and analysis
  • Learn about the new EMA task forces established to prepare the regulatory network for modern methods
  • Understand how you can prepare and plan for the future and benefit from the changes
  • Learn how clinical trials will be conducted in the next 20 years with the revision of the ICHE6
  • Understand how patients will benefit from shorter and more innovative clinical trials, more robust HTA assessments, new digital solutions to measure efficacy and how more real world evidence data will help to reduce risk and make decisions more certain

Programme

You can download the draft programme here.

Registration

Registration for the 32nd ERTC Workshop will open at the beginning of September 2021.

ERTC members will receive an email with the link to register

For any other registration category please contact Martina Bergna.

The event is recommended for the following target audience:

  • Pharmaceutical and biotech representatives with expertise in:
    • Regulatory Affairs
    • Research and Development
    • Health Technology Assessment (HTA) and Market Access
    • Medical Affairs and Clinical Trials
  • Clinical Research Organisations (CROs)
  • Academic/Medical institutions and patient groups involved in designing Clinical Trials
  • EURORDIS Summer School Alumni
  • European Medicines Agency and European Commission
  • Health Technology Assessment Agencies
  • European Reference Networks (ERNs)

Questions

Please send any questions concerning registration to Martina Bergna

We look forward to welcoming you to the EURORDIS Round Table of Companies.

 
 
The voice of rare disease patients in EuropeEURORDIS The international voice of people living with rare diseasesRare Disease International Bringing together patients, families and experts to share experiences in a moderated multi-language forum. RareConnect The Rare Barometer Programme is a EURORDIS initiative that carries out surveys to transform rare disease patients' experiences into figures and facts that can be shared with decision-makers.Rare Barometer An international awareness raising campaign taking place on the last day of February each year, Rare Disease Day is a EURORDIS initiativeRare Disease Day Join the largest gathering of rare disease stakeholders across Europe, at the biennial European Conference on Rare Diseases and Orphan Products. ECRD is a EURORDIS initiativeEuropean Conference on Rare Diseases