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:
- ACRO - Association of Clinical Research Organizations
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Anonymous contributor
- Association of German Research Ethics Committees (Germany)
- bluebird bio, Inc.
- Cancer Research UK / British Heart Foundation
- EAHP - European Association of Hospital Pharmacists
- EFPIA - European Federation of Pharmaceutical Industries and Associations
- Enpr-EMA
- EuropaBio - European Association for Bioindustries
- GMA - German Medical Association
- HRA - Health Research Authority (UK)
- IPFA - International Plasma Fractionation Association
- Jeremy Dearling
- Joachim Boos
- KKS-Network - Network of Coordinating Centers for Clinical Trials (Germany)
- MPA - Medical Products Agency (Sweden)
- Nextrasearch di Gasparetto Adolfo & C.
- NIHR - National Institute for Health Research (UK)
- Nuffield Council on Bioethics
- RCPCH - Royal College of Paediatrics and Child Health
- Relief Center for Evangelical Pastors (Germany)
- Regeneron Pharmaceuticals, Inc.
- RITIP - Translational Research Network in Pediatric Infectious Diseases
- RQA - Research Quality Association
- SIOP Europe
- Teva Pharmaceutical Industries Ltd.
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 revision of the document "Ethical Considerations for Clinical Trials on Medicinal products conducted with Minors" in preparation for the implementation for the Clinical Trials Regulation (EU) No 536/2014.
The main objective of this revision is to align the document with the Clinical Trials Regulation (EU) No 536/2014 and with the latest (scientific) insights on research with children.
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.