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 9 October 2009 to 8 January 2010.
Contributions to and results of the consultation
A summary of the responses is available here.
The following submitting parties requested their submission not to be published: Ian Beaumont, Roche (partly), Shire, University of Bristol, United Kingdom Paediatric Oncology Pharmacy Group, ActoGeniX, Hammersmith (partly).
Below are the public responses to the abovementioned consultation paper:
- abpi - Association of the British Pharmaceutical Industry
- ACRO - Association of Clinical Research Organizations
- AESGP - Association of the European Self-Medication Industry
- afssaps - Agence française de sécurité sanitaire des produits de santé
- Arbeitskreis Medizinischer Ethik Kommissionen in der Bundersrepublik Deutschland
- amrc - The UK Association of Medical Research Charities
- Astellas Pharma Europe B.V.
- Barts and The London
- Baxter World Trade SA
- BAPU - Belgian Association of Phase I Units
- Raymond Bell
- Bristol Royal Infirmary - British Nuclear Medicine Society
- British Heart Foundation
- BPI - Bundesverband der Pharmazeutischen Industrie
- Bundesärztekammer
- Cancer Research UK
- CCMO - Centrale Commissie Mensgebonden Onderzoek
- CEIC - Portuguese Ethical Committee for Clinical Research
- Celgene
- CliniGene-NoE
- CNCP - Conférence Nationale française des Comitésde Protection des Personnes dans la recherche biomédicale
- Cochrane
- CTSU - Clinical Trial Service Unit - Oxford University
- Danish Ministry of Health and prevention
- DCRIN - Danish National Clinical Research Infrastructure of ECRIN
- DGPharMed - Deutsche Gesellschaft fuer Pharmazeutische Medizin
- EANM - European Association of Nuclear Medecine
- EBE - European Biopharmaceutical Enterprises
- EBMT - European Group for Blood and Marrow Transplantation
- ECCO - European CanCer Organisation
- ECPC - European Cancer Patient Coalition
- ECRIN TWG - European Clinical Research Infrastructures Network - Transnational Working Groups : [1] - [2]
- efpia - European Federation of Pharmaceutical Industries and Associations : [1] - [2] - [3]
- EIPG - European Industrial Pharmacists Group
- ELN - European LeukemiaNet : [1] - [2]
- EMA - European Medicines Agency
- EMA - European Medicines Agency - EudraVigilance Expert Working Group
- EMRC - European Medical Research Councils (ESF)
- EORTC - European Organisation for Research and Treatment of Cancert : [1] - [2] - [3] - [4]
- EPF - European Patients' Forum
- EUCOPE - European Confederation of Pharmaceutical Entrepeneurs
- ESF - European Science Fondation : [1] - [2] - [3]
- EUCROF - European CRO Federation
- EuropaBio - European Association for Bioindustries
- European Consulting and Contracting in Oncology
- European Hematology Association
- European Society of Gene and Cell Therapy
- ESR - European Society of Radiology
- Estonian Hospitals Association
- FEAM - Federation of the European Academies of Medicine
- FPM - Faculty of Pharmaceutical Medicine of The Royal Colleges of Physicians of The United Kingdom
- German Federal Competent Authorities and the Federal Ministry of Health
- GILEAD - Advancing Therapeutics Improving Lives
- Peter J Goadsby
- GMDS e.V. - German Association for Medical Informatics, Biometry and Epidemiology
- GOSH - Great Ormond Street Hospital for Children NHS Trust
- GPOH - Society of Pediatric Oncology and Hematology
- Gregory Fryer Associates
- Ritva Halila, M.D., Ph.D., Adjunct Professor
- Hammersmith
- HMA - CTFG - Heads of Medicines Agencies - Clinical Trials Facilitation Group : [1] - [2]
- Hoffmann-La-Roche Ltd., Basel Switzerland
- HOPE - European Hospital and Healthcare Federation
- Hungarian Health Administration : [1] - [2]
- ICR - The Institute of Clinical Research
- KKS Netzwerk
- Kymenlaakson sairaanhoitopiiri / Eettinen toimikunta
- Leem - Les entreprises du médicaments
- Lithuanian Bioethics Committee
- Dr Alex McMahon, Reader in Epidemiology, Glasgow University Dental School : [1] - [2]
- Medical Products Agency, Sweden
- MHRA - Medicines and Healthcare Products Regulatory Agency
- Ministerio de Sanidad y Politica Social
- MKVT - Hungarian Clinical Trial Management Society : [1] - [2]
- mnda - motor neurone disease association
- MRC - Medical Research Council : [1] - [2] - [3]
- MSD - Merck Sharp & Dohme (Europe) Inc.
- NCRI PET Research Network
- NHS - National Health Service UK
- NIHR CRN - National Institute for Health Research Clinical Research Network
- NIHR Medicines for Children Research Network
- John P Osborne, Professor of Paediatrics and Child Health
This paper was published in Archives of Disease in Childhood, 2009, 94, page 729 to 733 - Pfizer
- Duncan Porter, Senior Lecturer, University of Glasgow
- Regulatory Authority in the Czech Republic : [1] - [2] - [3]
- REVISE - French academic clinical trials safety working group
- Christopher Roy-Toole
- Royal College of Physicians
- Royal College of Radiologists
- Sanofi aventis : [1] - [2]
- SIOPE - European Society for Paediatric Oncology
- SOMO and Wemos
- TRANSBIG
- TRREE-for Africa - Training and Resources in Research Ethics Evaluation
- UCL - University College London
- UK Academy of Medical Sciences
- UK Radiopharmacy Group
- University of Oxford and Oxford Radcliffe Hospitals Trust
- UoB - University of Birmingham - Human Disease, Diagnosis and Treatment (HDDT) Collaborative Research Network
- UZ/KULeuven
- Wellcome Trust
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.
Additional information:
Respond to the consultation
The response period for this consultation has ended. Thank you for your input.