Speakers and Moderators

These speakers have already confirmed:
Richard Bonner
UK, Formerly Senior Quality Advisor for Eli Lilly and Company, Chairman ECA and EQPA
Dr Christopher Burgess
Chairman of ECA‘s Working Group on Quality Control
Dr Klaus Eichmüller
District Government of Upper Bavaria Munich, GMP Inspectorate, Germany
Dr Matthias Heuermann
European GMP Inspector, Germany
Dr Afshin Hosseiny
Chairman of ECA‘s GDP Interest Group
Dr Jean-Denis Mallet
SNC Lavalin, France, ECA Advisory Board Member
Gert Moelgaard
NNE Pharmaplan and co-Chair of ECA‘s Working Group on Validation
Dr Bernd Renger
Qualified Person, Immediate Past Chairman European QP Association
Dr Renate Schenk-Gröninger
Boehringer Ingelheim Pharma, Germany and co-Chair of ECA‘s Working Group on Validation
Dr Thomas Schneppe
Bayer Pharma, Germany and co-chair of ECA‘s Working Group on Validation

 

Speakers and Moderators of the 4th European GMP Conference

Bernd Bödecker
Trade & Industry Inspection Agency of Lower Saxony, Hannover office, GMP Inspector. Member of national and international official expert circles dealing with QRM.
 

Matt Moran
Pharma Chemical, Ireland
Vice President APIC/CEFIC and ECA Advisory Board Member
Richard Bonner
UK, Formerly Senior Quality Advisor for Eli Lilly and Company, ECA Advisory Board Membe
 

Dr Gabriele Reich
University of Heidelberg
Senior Lecturer at the Institute of Pharmacy and Molecular Biotechnology (IPMB).
Dr Antony Fake
WHO, Switzerland, Technical Officer, Active Pharmaceutical Ingredient Focal Point
Dr Wolfgang Schumacher
F. Hoffmann-La Roche, Switzerland
Member of the IT Quality Unit, ECA Advisory Board Member
Philippe Legoff
Managing Director H&LG Consultants, Switzerland
Dr Janeth Soreth
Deputy Director Europe/US FDA
Silke Mainka
Lawyer, Germany. Attorney in the field of international contracting.
 

Ian Thrussel
MHRA, UK
Expert GMP Inspector of MHRA, Member of ICH Q10 Expert Working Group
Dr Jean-Denis Mallet
SNC Lavalin, France, ECA Advisory Board Member
 

Lionel Viornéry
AFSSAPS, France
Head of the Starting Material Inspection Unit of AFSSAPS
Julie Maréchal-Jamil
Senior Manager Regulatory Affairs at the European Generic Medicines Association (EGA)
 

Rudolf Völler
Regional Council Darmstadt, Germany
Senior GMP Inspector and ECA Advisory Board Member
Grace McNally
Senior Senior Policy Advisor, US FDA
Dr Grace Yi-Ni Ye
SFDA, China
Gert Moelgaard
Vice President NNE Pharmaplan, Denmark
   


Speakers and Moderators of the 3rd European GMP Conference

(picture not available) Mr Thomas J. Arista
Mr. Arista is a member of the Office of Regulatory Affairs (ORA) Field Investigator National Expert Cadre at FDA
Dr Gabriele Reich
University of Heidelberg
Senior Lecturer at the Institute of Pharmacy and Molecular Biotechnology (IPMB).
Hélène Bruguera
European Directorate for the Quality of Medicines (EDQM & Health Care), France
Deputy Head of Division and in charge of the management of revisions of CEPs.
Dr Bernd Renger
Vetter Pharma-Fertigung GmbH & Co. KG, Germany
Director of Quality Control, Chairman European QP Association
Christopher Burgess Dr Christopher Burgess
Burgess Consultancy, Barnard Castle, UK
Qualified Person and a member of the European QP Association Advisory Board
Benoît Rime
United States Pharmacopeia (USP), USA
Senior International account manager, Mainland Western Europe
Eileen Counihan
Merck Sharp & Dohme Ltd, Ireland. Director Commercialization and EMEA Compliance
 
Daniel Scheidegger Daniel Scheidegger
Genzyme, Switzerland
Managing Director Genzyme Switzerland, Chairman ECA
Dr Josef Hofer
Director of exdra GmbH (excellence in drug regulatory affairs.) and assistant lecturer at the University in Bonn for Regulatory Affairs.
Thomas Schneppe Dr Thomas Schneppe
Since 2006 Bayer Schering Pharma; Head of Mgmt. Training at Bayer Health Care - Product Supply - Compliance - Integrated Quality Mgmt.
Dr Jean-Denis Mallet
International Committee Red Cross Pharmaceutics, Switzerland
Stephan Schwarze Dr Stephan Schwarze
Head of Counterfeit Protection Management since 2005 within Bayer Schering Pharma AG. He is a member of WHO IMPACT's Technology Subgroup as well as of EFPIA's Anti-Counterfeiting ad hoc working group.
Heinrich Prinz Dr Heinrich Prinz
Dr Prinz is senior supervisor of Quality Control and Quality Assurance at CellMed AG and works also as a freelance Consultant.
Wolfgang Schumacher Dr Wolfgang Schumacher
F. Hoffmann-La Roche, Switzerland
Member of the IT Quality Unit, ECA Advisory Board Member
Boris Pimentel Dr Boris Pimentel
DNP (DSM-Nutritional Products), Switzerland
Vice President APIC/CEFIC and ECA Advisory Board Member
Michael Ulmschneider Dr Michael Ulmschneider
Member of the PAT and analytical business process group at Hoffmann-La Roche in Basel  
       
Speakers and Moderators of the 2nd European GMP Conference
Frederick W. Blumenschein
FDA, USA
Chief, Case Management and Guidance Branch Division of Manufacturing and Product Quality Office of Compliance
Dr Johanna Eisele
Degussa Pharma Polymers, Germany
Member of IPEC Europe RA & GMP Committee
David Cockburn
EMEA, UK
Principal Scientific Administrator, Inspections Sector
Dr Ludwig Huber
Agilent Technologies, Germany
ECA Advisory Board Member
Dr Jacques Morénas
AFSSAPS, France
Member of ICH Expert Working Group (Q9 and Q10), Chairman PIC/S
Dr Michael Jahnke
Wülfing Pharma GmbH, Germany
Head of Quality Assurance Wülfing Pharma
Dr Susanne Keitel
BfArM, Germany
Head of EU and International Affairs at BfArM and Member of the ICH Q8 Working Group
Kenneth J. Leiper
Benson Associates
Chair of ASTM Pharmaceutical Application of Process Analytical Technology Committee E55.01
John Taylor
MHRA, UK
Quality and Standards Manager Acting and Group Manager, Enforcement and Intelligence
Matt Moran
PharmaChemical, Ireland
President APIC/CEFIC and ECA Advisory Board Member
Dr Sabine Paris
ZLG, Germany
Head of Department Medicinal Products / Central Coordination Unit
Dr Boris Pimentel
DNP (DSM-Nutritional Products), Switzerland
Vice President APIC/CEFIC and ECA Advisory Board Member
Dr Dirk Barends
RIVM
Senior Scientist Working on NIRS/PAT within RIVM
Dr Gabriele Reich
University of Heidelberg
Senior Lecturer at the Institute of Pharmacy and Molecular Biotechnology (IPMB)
Rudolf Völler
Regional Council Darmstadt, Germany
Senior GMP Inspector and ECA Advisory Board Member
Dr Bernd Renger
Vetter Pharma-Fertigung GmbH & Co. KG, Germany
Director of Quality Control, Chairman European QP Association
Dr Jürgen Mählitz
District Government of Upper Bavaria, Germany
GMP Inspector
Daniel Scheidegger Daniel Scheidegger
Genzyme, Switzerland
Managing Director Genzyme Switzerland, Chairman ECA
Dr John Berridge
Member of the ICH Q8 Working Group
Jef Van Schuerbeek
Consultant, Belgium
Formerly in pharmaceutical R&D at Lilly Clinical Operations
Richard Bonner
UK, Formerly Senior Quality Advisor for Eli Lilly and Company, ECA Advisory Board Member
Dr Wolfgang Schumacher
F. Hoffmann-La Roche, Switzerland
Member of the IT Quality Unit, ECA Advisory Board Member
Colin Booth
Oxoid Limited, UK
Vice President Science and Technology at Oxoid, ECA Advisory Board Member