Fagg/Internationale vertegenwoordiging versie: 01.06.2016 1

Internationale vertegenwoordiging

EMA Management Board (EMA MB) Xavier De Cuyper, Administrateur-generaal Greet Musch (DG PRE vergunning)

EMA Committees CAT Claire Beuneu (DG PRE vergunning)

Belaïd Sekkali (DG PRE vergunning) CHMP Daniel Brasseur

Christophe Focke (DG PRE vergunning) Valérie Lescrainier (DG PRE vergunning)

CVMP Frédéric Klein (DG PRE vergunning) Bruno Urbain (DG PRE vergunning)

Committee for Orphan Medicinal Products – COMP

André Lhoir (DAG)

Committee on Herbal Medicinal Products – HMPC

Gert Laekeman Heidi Neef (DG PRE vergunning)

Paediatric Committee – PDCO Jacqueline Carleer (DG PRE vergunning) Koen Norga

Pharmacovigilance Risk Assessment Committee - PRAC

Jean-Michel Dogné Veerle Verlinden (DG POST vergunning)

CHMP/CVMP Working Parties Joint CHMP/CVMP Quality Working Party – QWP (Standing Working Party)

Katrien Van Landuyt (DG PRE vergunning) René Hanselaer (DG PRE vergunning)

Joint CVMP/CHMP ad-hoc Working Group on the Application of the 3Rs (Replacement, Reduction and Refinement) in the Development of Medicinal Products (Temporary Working Party)

Sonja Beken (DG PRE vergunning)

CHMP Working Parties BWP (Standing Working Party) Alan Fauconnier (DG PRE vergunning) Safety Working Party – SWP (Standing Working Party)

Sonja Beken (DG PRE vergunning) Karen De Smet (DG PRE vergunning)

Scientific Advice Working Party – SAWP (Standing Working Party)

Minne Casteels Dieter Deforce Walter Janssens (DG PRE vergunning) Marleen Laloup (DG PRE vergunning)

Similar Biological (Biosimilar) Medicinal Products Working Party – BMWP (Temporary Working Party)

Karen De Smet (DG PRE vergunning)

Vaccine Working Party – VWP (Temporary Working Party)

Daniel Brasseur Karen De Smet (DG PRE vergunning)

CVMP Working parties Efficacy Working Party – EWP-V (Standing Working Party)

Sandy Vermout (DG PRE vergunning)

Pharmacovigilance Working Party – PhVWP-V (Standing Working Party)

Els Dewaele (DG POST vergunning)

Safety Working Party – SWP-V (Standing Working Party)

Philippe Delahaut

Scientific Advice Working Party – SAWP-V (Standing Working Party)

Frédéric Klein (DG PRE vergunning) Bruno Urbain (DG PRE vergunning)

Working Group on Quality Review of documents – (human + veterinary) (Associated groups) (Standing Working Party)

Valérie Van Merris (DG PRE vergunning)

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EMA and its Working Groups EudraCT Kristof Bonnarens (DG PRE vergunning)

Pieter Vankeerberghen (Od) EudraGMP Pieter Vankeerberghen (Od) EudraLink Nicolas Leroy (Od) Eudranet Nicolas Leroy (Od) EudraPharm Godefroid Wokala Libambu (Od) EudraVigilance Human Nicolas Leroy (Od)

Olivier Bouffioux (DG POST vergunning) Dieter Cenens (DG POST vergunning)

EudraVigilance Veterinary Els Dewaele (DG POST vergunning) Nicolas Leroy (Od)

Eurs Pieter Vankeerberghen (Od) GCP Inspectors Working Group Dominique Delforge (DG INSPECTIE)

Sarah T’Kindt (DG INSPECTIE) GMP/GDP Inspectors Working Group Karin Froidbise (DG INSPECTIE)

Catherine Planchon (DG INSPECTIE) Wim Van Linden (DG INSPECTIE)

(Invented) Name Review Group – NRG (Associated groups) (Standing Working Party)

Vanessa Binamé (DG POST vergunning) Valérie Lescrainier (DG PRE vergunning) Valérie Willox (DG PRE vergunning)

Pharmacovigilance Inspectors Working Group – PhV IWG

Christophe Debruyne (DG INSPECTIE) Nele Matthijs (DG INSPECTIE)

Process Analytical Technology Team – PAT Team

Catherine Planchon (DG INSPECTIE) Wim Van Linden (DG INSPECTIE)

Virtual Advertising Network Alain Denis (DG INSPECTIE) EU Telematics Controlled Terms – EUTCT Pieter Vankeerberghen (Od) TIGes-veterinary subgroup Pieter Vankeerberghen (Od)

HMPC Working Party Quality Drafting Group – DG Q (Temporary Working Party)

Heidi Neef (DG PRE vergunning)

HMPC Working Party on Community Monographs and Community Lists (MLWP) (Standing Working Party)

Gert Laekeman Arnold Vlietinck

PDCO Working Party Non-Clinical Working Group Jacqueline Carleer (DG PRE vergunning) Paediatric Formulation Working Group Isabelle Delneuville (DG PRE vergunning)

HMA and its Working Groups Working Group implementation of the AMR Revised Action Plan

Greet Musch (DG PRE vergunning)

HMA Management Group – HMA-MG Xavier De Cuyper, Administrateur-generaal Clinical Trials Facilitation Group – CTFG Kristof Bonnarens (DG PRE vergunning)

Greet Musch (DG PRE vergunning) CMDh Sophie Colyn (DG PRE vergunning)

Katelijne Van Keymeulen (DG PRE vergunning) Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary – CMDv

Valérie Van Merris (DG PRE vergunning)

EMACOLEX Steven Hippe (DAG) Task Force on Improvement of Veterinary Medicines Legislation

Greet Musch (DG PRE vergunning)

Heads of Medicines Agencies – HMA Xavier De Cuyper, Administrateur-generaal Els Geeraerts (DAG)

Homeopathic Medicinal Products Working Group – HMPWG

Marie-Anne Mouyart (DG PRE vergunning) Patricia Bodart (DG PRE vergunning)

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Telematics Support Group Magali Durieux (Od) Pieter Vankeerberghen (Od)

Working Group of Communication Professionals – WGCP

Ann Eeckhout (DAG)

WGEO Roy Vancauwenberghe (DG INSPECTIE) Working Group of Quality Managers (WGQM) Christelle Beeckmans (DAG)

Véronique De Troyer (DAG) Veterinary experts working Group Dries Minne (DG PRE vergunning)

Council of Europe Committee of Experts on the Classification of Medicines as Regards their Supply – CD-P-PH/PHO

Eline Vanderbiest (DG POST vergunning)

European Committee on Blood Transfusion – CD-P-TS

Ludo Muylle (DG POST vergunning)

European Committee on Organ Transplantation – CD-P-TO

Leen Coene Ludo Muylle (DG POST vergunning)

European Committee on Pharmaceuticals and Pharmaceutical Care – CD-P-PH

Josiane Van der Elst (DG INSPECTIE)

Committee of Experts on minimising the public health risks posed by counterfeiting of medical products and related crimes – CD-P-PH/CMED

Roy Vancauwenberghe (DG INSPECTIE)

Committee of Experts on quality and safety standards in pharmaceutical practices and Pharmaceutical Care – CD-P-PH/PC

Alain Bya (DG INSPECTIE)

European Pharmacopoeia Commission Katrien Van Landuyt (DG PRE vergunning) Pompidou Group Charles Denonne

ad-hocexperten Council of European Ministers

Working Party on Pharmaceuticals and Medical Devices

Els Geeraerts (DAG) ad-hocexperten

European Commission Ad-hoc Group on Clinical Trials Greet Musch (DG PRE vergunning)

Kristof Bonnarens (DG PRE vergunning) Central Management Committee – CMC Vanessa Binamé (DG POST vergunning)

Anne Van Nerom Competent Authorities for Medical Devices (CAMD)

Vanessa Binamé (DG POST vergunning) Anne Van Nerom

Electronic Labelling Working Group Frédérique Meulders (DG POST vergunning) Eudamed Working Group Damien Lambot (DG POST vergunning)

Frédérique Meulders (DG POST vergunning) Philippe Scohy (Od) Anne Van Nerom

Medical Devices Expert Group on Borderline and Classification

Frédérique Meulders (DG POST vergunning) Anne Van Nerom

Meeting of the Competent Authorities for blood and blood components

Ludo Muylle (DG POST vergunning)

Competent Authorities for TISSUES AND CELLS Ludo Muylle (DG POST vergunning) Medical Devices EXPERT Group – MDEG Frédérique Meulders (DG POST vergunning)

Anne Van Nerom Notice to Applicants – NTA Sophie Colyn (DG PRE vergunning) - humaan

Valérie Van Merris (DG PRE vergunning) – veterinair Anne Wespes (DAG)

Pharmaceutical Committee – human Els Geeraerts (DAG)

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Wim Penninckx (DG PRE vergunning) Pharmaceutical Committee – veterinary Els Geeraerts (DAG)

Greet Musch (DG PRE vergunning) Process on Corporate Responsibility in the field of Pharmaceuticals

Els Geeraerts (DAG)

Regulatory Committee on quality and safety of blood

Ludo Muylle (DG POST vergunning)

Regulatory Committee on Tissues and Cells Ludo Muylle (DG POST vergunning) Regulatory Committee on Medical Devices Vanessa Binamé (DG POST vergunning)

Anne Van Nerom Standing Committee – human Els Geeraerts (DAG)

Greet Musch (DG PRE vergunning) Standing Committee – veterinary Els Geeraerts (DAG)

Greet Musch (DG PRE vergunning) Valérie Van Merris (DG PRE vergunning)

Transparency Committee Els Geeraerts (DAG) TSE/BSE Working Group Frédérique Meulders (DG POST vergunning) Vigilance Working Group (Materiovigilance) Damien Lambot (DG POST vergunning)

Sébastien Vanackere (DG POST vergunning) Anne Van Nerom

Working Group on CIE Steve Eglem (DG POST vergunning) Greet Musch (DG PRE vergunning)

IVD Technical Group Greet Musch (DG PRE vergunning) Anne Van Nerom

New & Emerging Technologies Working Group (NET) Anne Van Nerom

Compliance and Enforcement Group (COEN) Anne Van Nerom

Notified Body Operations Group (NBOG) Katrien Martens (DG INSPECTIE) Anne Van Nerom

Working Group on coding of tissues and cells Ludo Muylle (DG POST vergunning) PIC/s

PIC/s Committee Karin Froidbise (DG INSPECTIE) Josiane Van der Elst (DG INSPECTIE)

UNO Commission on Narcotic Drugs – CND Greet Declerck (DG INSPECTIE)

ad-hocexperten International Narcotics Control Board – INCB Greet Declerck (DG INSPECTIE)

ad-hocexperten WHO

International Medical Products Anti-Counterfeiting Taskforce (IMPACT)

Daniel Reynders Roy Vancauwenberghe (DG INSPECTIE)