This event has ended.
- medicinal product
- Tuesday 9 March 2021, 01:00 - Wednesday 10 March 2021, 01:00 (CET)
Practical information
- When
- Tuesday 9 March 2021, 01:00 - Wednesday 10 March 2021, 01:00 (CET)
- Languages
- English
Report
9-10 March 2021
The Clinical Trials Regulation (EU) 536/2014 is foreseen to become applicable at the end of January 2022. In order to support Member States with its implementation, DG SANTE of the European Commission, the European Medicines Agency and the Clinical Trials Facilitation and Coordination Group of the Heads of Medicines Agency jointly organised a training on 9-10 March, 2021. Assessors, inspectors and ethics committee members from each EU/EEA Member State were invited to attend the training. The aim of the training was to provide an overview of key changes under the Clinical Trials Regulation.
Additional supporting documents can be found on Eudralex-10. Volume 10 of the publication "The rules governing medicinal products in the European Union" contains links to guidance documents applying to clinical trials. These documents, amongst others, include:
- Part II application document templates
- Draft Q&A for the Clinical Trials Regulation (EU) 536/2014
- Q&A on the interplay of the CTR and GDPR
Recordings of the training (for password protected publication):
Written answers to questions from the training:
Presentations
Day 1
- Clinical Trial Regulation 536/2014 - General principles and new concepts
European Commission - DG Health and Food Safety - Submission and assessment of a new clinical trial application when the Regulation (EU) No 536/2014 applies
Medical Products Agency (Sweden) - Low intervention clinical trials
Agencia Española de Medicamentos y Productos Sanitarios (Spain) - Initial application : submission and assessment ( II ) Decision , partial applications (Part I only with later Part II), trial expansion into additional MSCs
Federal Agency for Medicines and Health Products (Belgium) - Study vs trial
Medicines and Medical Devices Agency (Austria) - EU Clinical Trial Regulation (536/2014) - Normal Clinical Practice
National Clinial Trial Office CCMO (The Netherlands) - EU Clinical Trial Regulation (536/2014) - Informed Consent
National Clinial Trial Office CCMO (The Netherlands) - Clinical Trial Regulation 536/2014 - Additional Protection for specific Study Populations
Association of Medical Ethics Committees (Germany) - Part II Templates
CT College (Belgium) - Clinical Trial Regulation 536/2014 - Changes to clinical trials (classification and submission of non-substantial changes)
European Commission - DG Health and Food Safety - Changes to clinical trials
Medicines and Medical Devices Agency (Audtria) - Changes to trials (submission and classification)
Medicines Agency (Denmark) - Union Controls
European Commission - DG Health and Food Safety - Safety Reporting Assessment
Federal Institute for Drugs and Medical Devices (Germany) - Requirements for the reference safety information under the Clinical Trials Regulation
Federal Agency for Medicines and Health Products (Belgium) - Safety reporting and assessment
CTFG - Clinical Trials Facilitation and Coordination Group - Clinical Trial Regulation 536/2014 Coordinated safety assessment under Art 44.2 (COM Implementing Regulation)
European Commission - DG Health and Food Safety
Day 2
- National aspects in the CTR and Member State preparedness
Medicines and Medical Devices Agency (Austria) - CTFG - Clinical Trials Facilitation and Coordination Group
Federal Institute for Drugs and Medical Devices (Germany) - CTR training - Member State preparedness and national aspects
Medicines agency (Finland) - CTR: Member State preparedness and national aspects - Independant Ethics committees in France
Commission Nationale des Recherches Impliquant la Personne Humaine (France) - Manufacturing/importation and labelling (Chapter IX, X, Annex VI)
Medicines Agency (Italy) - CTIS publication rules: How CTIS supports access to clinical trial data
European Medicines Agency - Data protection aspects of clinical trials
European Commission - DG Health and Food Safety - Member States preparedness for the use of CTIS
European Medicines Agency - Member States preparedness for the use of the EU Portal
INFARMED –National Authority of Medicines and Health Products (Portugal) - Clinical Trial Regulation 536/2014 - Arrangements for the transition period
European Commission - DG Health and Food Safety - Transition – Safety reporting
Federal Institute for Drugs and Medical Devices (Germany) - Transition of multi-national clinical trials from the voluntary harmonisation procedure (VHP) to the Clinical Trial-Regulation (CTR 536/2014)
HMA - Heads of Medicines Agency - Clinical Trial Regulation 536/2014 - Cooperation between Member States and the European Commission
European Commission - DG Health and Food Safety - Clinical Trials Facilitation and Coordination Group - Cooperation between Member States and the European Commission
Medical Products Agency and Federal Institute for Drugs and Medical Devices (Sweden)