October
3
Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency*
Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future - A joint conference of the European Commission and the European Medicines Agency
3 October 2007EMEA, Canary Wharf, London, UK
Please note that the size of some of the documents listed here exceed 50 pages. You are therefore advised to be selective about which sections or pages you wish to print.
Main report
Conference Report (main report, conference programme and list of attendees)
Presentations
Download either all presentations combined [PDF 6.73MB] or individual presentations:
Thomas Lönngren
Alan Morrison (session 2)
Monique Podoor
Hartmut Krafft
Michael Fuchs
Fernand Sauer
Gaby Danan
Stefan Bielack
Brian Davis
Pierre Henri Bertoye
Dominique Sprumont
Rory Collins
Silvio Garattini
Jacques Demotes-Mainard (session 4)
John Poland
Dagmar Chase
Nikos Dedes
Alan Morrison (session 4)
Mats Ericson
Ritva Halila
Chantal Bélorgey
Stefan Bielack (session 5)
Jacques Demotes-Mainard (session 5)
François Chapuis
Octavi Quintana Trias
Written submissions
Download either all submissions combined [PDF 1.24MB] or individual submissions:
ACRO - Association of Clinical Research Organizations
AFSSAPS - French Health Products Safety Agency
Association of the European Self-Medication Industry
Cancer Research UK
CPP - France
CTFG - Clinical Trials Facilitation Group (Belorgey)
CTFG - Clinical Trials Facilitation Group (Davis)
CTFG - Clinical Trials Facilitation Group (Krafft)
Czech Republic, State Institute for Drug Control
ECRIN, EORTC, ESF, CPI, INSERM, VISEAR, ECISM
EBMT - European Group for Blood and Marrow Transplantation
EC - Directorate General for Research and Technology Development
EFGCP - European Forum for Good Clinical Practice
EFPIA - European Federation of Pharmaceutical Industries and Associations
EGAN - European Genetic Allliance’s Network
ESDP - European Society for Developmental, Perinatal and Paediatric Pharmacology
Ethics Committee Medica University of Vienna
EUCROF - European CRO Federation
EULAR - European League Against Rheumatism
EUREC - European Network of Research Ethics Committees
EuropaBio
European Association of Nuclear Medicine
European Hematology Association
Finland - Ethics Committee
Finland NCA
GCP IWG - GCP inspections working group
Good Clinical Practice Alliance Europe
HCP WP - EMEA/CHMP Working Group with Healthcare Professionals’ Organisations (Youle)
International Society for Pharmaceutical Engineering
Irish Platform for Patients' Organisations
Italian Medicines Agency
Mario Negri Institute
MCRN - Medicines for Children Research Network
PAED-net - Paediatric-Network Germany
EMEA Human Scientific Committees Working Party with Patients’ and Consumers’ Organisation (PCWP)
Poland - Ministry of Health
PPTA - Plasma Protein Therapeutics Association
SIOP Europe - Société Internationale d’Oncologie Pédiatrique
Spain - Agencia Española de Medicamentos y Productos Sanitarios
Task Force in Europe for Drug Development for the Young
Spontaneous submissions
CNCP Conference National of committees of protection of persons (REC)
Directive and Research Governance in Europe
European Cancer Patient Coalition (ECPC)
GCP - Records Managers Association
HCP WP - EMEA/CHMP Working Group with Healthcare Professionals’ Organisations (HCP WG) (Sampaio)
Novartis
Biographies
Biographies of chairs, speakers and panellists
Questions/comments received after the conference
Questions/comments received after the conference
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