Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 1 June 2016 to 31 August 2016.
Contributions to and results of the consultation
A summary of the responses is available here.
Below are the public responses to the above-mentioned public consultation:
- The Academy of Medical Sciences (UK)
- ACRO - Association of Clinical Research Organizations
- ACRP - Association of Clinical Research Professionals
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- BEUC - The European Consumer Organisation
- Cancer Research UK / British Heart Foundation
- CCMO - Central Committee on Research Involving Human Subjects
- CISCRP - The Center for Information and Study on Clinical Research Participation / Synchrogenix Information Strategies, Inc.
- Danish Medicines Agency
- EAHP - European Association of Hospital Pharmacists
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- EORTC - European Organisation for Research and Treatment of Cancer
- EUCROF - European CRO Federation
- EUFEMED - European Federation for Exploratory Medicines Development
- EuropaBio - European Association for Bioindustries
- Gilead Sciences International Ltd.
- GHP - Guild of Healthcare Pharmacists (UK)
- HRA - Health Research Authority (UK)
- Dr. Ingo Rath of CliPS - Clinical Project Services (Germany)
- IPFA - International Plasma Fractionation Association
- Jeremy Dearling
- KKS-Network - Network of Coordinating Centers for Clinical Trials (Germany)
- MPA - Medical Products Agency (Sweden)
- Nuffield Department of Population Health, University of Oxford
- Nextrasearch di Gasparetto Adolfo & C.
- NIHR - National Institute for Health Research (UK)
- NvFG - Nederlandse Vereniging van Farmaceutisch Geneeskundigen
- Prescrire
- Regeneron Pharmaceuticals, Inc.
- RQA - Research Quality Association
- Teva Pharmaceutical Industries Ltd.
- Willian Cragg
- Zeincro Hellas SA
Targeted stakeholders
All citizens and organisations are welcome to contribute to this consultation.
Objective of the consultation
With this public consultation the Directorate General for Health and Food Safety, DG SANTE, intends to seek the views of stakeholders – and other interested parties - on the document regarding "Risk proportionate approaches in clinical trials" which has been developed in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
The main objective of these recommendations is to provide further information on how a risk proportionate approach can be implemented in clinical trials and also highlights the areas identified in the clinical trials Regulation which support and facilitate such adaptations.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.
Specific privacy statement
Please consult the Privacy Statement to be downloaded here.