.
Speakers
Speakers from Authorities, Inspectorates and Associations
Dr Rainer Gallitzendörfer, Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA and accredited as a technical assessor for testing laboratories (DIN EN ISO/IEC 17025) in the sector committee “Consumer Health Protection”
Dr Rainer Gnibl, Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA, Advisory Board member of the Qualified Person Association
Dr Thomas Hecker, EDQM, Council of Europe
Scientific Officer
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 Industry
Alexandra Bauloye, GlaxoSmithKline, Belgium
Risk Management and Governance Lead, GSK Corporate
Cheryl Chia, Lotus Phoenix Consulting, Netherlands
Consultant for GMP and GDP compliance in the pharmaceutical supply chain
Fabio Cirillo, Avanti Europe AG, Switzerland
Managing Director and Senior Consultant for Medical Devices and Drug Device Combinations
David Cockburn, European Qualifi ed Person Association (EQPA)
Member of the EQPA Board of Directors. Former Chair of the EMA GMP/GDP IWG
Tara Cox, Takeda, Ireland
Head of Device Quality and Regulatory Compliance
Martinus de Jonge, AstraZeneca, Netherlands
Qualified Person, Associate Director, Development Quality, Biologics
Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products and member of the EQPA Board of Directors
Dr Andreas Flückiger, form. Roche, Switzerland
Former Chief Occupational Health Officer for the Roche Group (retired)
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
Energy Kristina Hansen, MilCor Consulting, Denmark
Certified quality auditor (GMP/GDP/ISO) and consultant
Dr Afshin Hosseiny, Tabriz Consulting, U.K.
Managing Director and Qualified 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 Businees Operations
Dr Ulrich Kissel, KisselPharma Consulting, Germany
Qualified Person and Chairman of the EQPA Board of Directors
Aidan Madden, FivePharma, Ireland
CEO
Sue Mann, Sue Mann Consultancy Ltd. U.K.
Qualified Person and QP Assessor working on behalf of the MHRA, representing the Royal Pharmaceutical Society
Gábor Mihályi, MihaPharm Consultancy B.V., Netherlands
Qualified Person, Auditor and Consultant
Rafael Santis, Takeda, Switzerland
Cell Therapy Quality Head
Dr Peer Schmidt, AbbVie, Germany
Director Global Quality Systems
Dr Andreas Schwinn, Roche Pharma AG, Germany
Qualified Person, Head PQIP
Edel Shortt, Takeda, Ireland
Head of Product Quality Small Molecule and Oncology
Niina Taylor, Pfizer, U.K. & Ireland
Director Quality Assurance and Qualified Person
Brenda Van Assche, Janssen Pharmaceutica NV, Belgium
Senior Director Quality Assurance Clinical Supply Chain and Qualified Person
Other speakers invited