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Speakers
Speakers from Authorities, Inspectorates and Societies
Tobias Beer, European Medicines Verification Organisation (EMVO), Belgium
Chief Operating Officer
Dr Rainer Gnibl, Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA, Advisory Board member of the Qualifi ed Person Association
Anne Hayes, Health Products Regulatory Authority (HPRA), Ireland
Inspection Manager at HPRA and PIC/S Chairperson
Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES), Austria
Head Pharmaceutical Inspections and Member of Annex 16 Drafting Group
Catherine Neary, Irish Health Products Regulatory Authority (HPRA)
GMP Operations Manager
Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K.
Chair of the RPS QP Assessment Panel
Speakers from the Industry
Richard M. Bonner, U.K.
Former Chairman of the EQPA Board of Directors and former Chair of the ECA Executive Board
David Cockburn, European Qualifi ed Person Association (EQPA)
Member of the EQPA Board of Directors. Former Chair of the EMA GMP/GDP IWG
Sipi Dhaliwal, Merck Sharp & Dohme, U.K.
Associate Director and Qualified Person
Cristina De Simoni Klitgaard, Novo Nordisk, Denmark
Vice President Customer Complaint Center, Global Safety
Dr Fabienne Diekmann, Diekmann Lawyers, Germany
Lawyer with main focus on pharmaceutical industry
Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products, member of the EQPA Board of Directors and Chair of the IMP Working Group within the EQPA
DI Georg Göstl, Takeda, Austria
Qualified Person, Chair of the Austrian QP Association aqpa and member of the EQPA Board of Directors
Tor Gråberg, AstraZeneca, Sweden
Head of External Advocacy, Global Quality, Operations, and member of the EQPA Board of Directors. Former Head of the Drug Inspectorate at the Swedish Medical Products Agency and former PIC/S Chair
Dr Afshin Hosseiny, Tabriz Consulting, U.K.
Managing Director and Qualifi ed Person, Chair of the ECA Executive
Board and Chair of the European GDP Association
Patryk Jegorow, Takeda, Ireland
Qualified Person Biologics, Head of Quality Strategy and Business Operations
Dr Ulrich Kissel, KisselPharma Consulting
Qualified Person and Chairman of the EQPA Board of Directors
Karsten Lollike, Novo Nordisk, Denmark
Corporate Vice President and QPPV
Aidan Madden, FivePharma, Ireland
CEO and Qualified Person
Sue Mann, Sue Mann Consultancy Ltd. U.K.
Qualified Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society
Dr Peer Schmidt, AbbVie, Germany
Director Global Quality Systems
Dr Wolfgang Schumacher, formerly F. Hoff mann-La Roche Ltd., Switzerland
Former Head of the Quality Computer Systems department
Dr Andreas Schwinn, Roche Pharma AG, Germany
Qualified Person, Head PQIP
Niina Taylor, Pfizer, U.K.
Director Quality Assurance and Qualified Person
Brenda Van Assche, Janssen Pharmaceutica NV, Belgium
Director Quality Assurance Clinical Supply Chain and Qualified Person