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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