Speakers from Authorities and Public Health Organisations:
Dr Stefan Almeling, EDQM, France
Head of Analytical Chemistry Division; European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe.
Riekert Bruinink, Dutch Health Care Inspectorate, Netherlands
Group Chairman of the PIC/S GDP Working Group, Member of the European Medicines Agency (EMA) GDP Drafting Group.
Ian Holloway, MHRA, U.K.
GMP/GDP-Inspector at Medicines & Healthcare Products Regulatory Agency.
Dr Herbert Schmidt, WHO, Switzerland
Technical Officer at the World Health Organization, Quality Assurance and Safety: Medicines.
Dr Janice M. Soreth (invited), EU/US FDA
Deputy Director Europe, Office of International Programs, U.S. FDA (based at EMA, London, U.K.).
Edit Szöcs, Hungarian Drug Inspectorate
Inspector at the Hungarian Drug Inspectorate, National Institute of Pharmacy (NIP)
Speakers from the Industry:
Richard M. Bonner, formerly with Eli Lilly, U.K
Qualified Person, Advisory Board member of the Qualified Person Association
Dr Christopher Burgess, formerly with Glaxo, U.K.
Qualified Person, Advisory Board member of the Qualified Person Association. Visiting Professor at the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS).
Dr Alexander J.J. Debets, MSD Werthenstein BioPharma, Switzerland
Véronique Davoust, Pfizer France
PGS Global Quality Operations, Quality Strategy.
Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products.
Dr Afshin Hosseiny, Tabriz Consulting, U,K.
Qualified Person and Managing Director.
Dr Ulrich Kissel, Roche Pharma AG, Germany
Qualified Person and Advisory Board member of the Qualified Person Association.
Dr Jean-Denis Mallet, SNC Lavalin, France
Director Pharma Europe, formerly Head of the French Pharmaceutical Inspection Department (AFSSAPS). Member of the Advisory Board of the ECA Foundation.
Sue Mann, Sue Mann Consultancy Ltd. UK
Qualified Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society.
Ann McGee, McGee Pharma International, Ireland
Managing Director and Principal Consultant. Former Senior Inspector of the Irish Medicines Board and Deputy Chair of PIC/S.
Frank Raisch, GlaxoSmithKline, Germany
Attorney-at-Law and Legal Counsel.
Dr Bernd Renger, EQPA
Immediate Past Chairman of the Qualified Person Association.
Gillian Renouf, Eli Lilly, U.K.
Qualified Person and Regulatory and Quality Consultant EMACM.
Dr Björn Seidel, Team Connex, Germany
Certified Trainer and Systemic Coach. Formerly with Fraunhofer Institute for Molecular Biology.
Lance Smallshaw, UCB Pharma, Belgium
Global Director Analytical Strategy.
Niina Taylor, Pfizer, U.K.
Qualified Person and Director Quality Assurance.
Martine Tratsaert, Johnson & Johnson, Belgium
Senior Director Market Quality EMEA.
Philippe Van de Hofstadt, B&C Group, Belgium
CEO of B&C, a Clinical Research Packaging & Logistics Organisation.
Dr Dirk Theodoor Witte, Abbott Logistics, Netherlands
Head of the Quality Unit.