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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). 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 (invited)
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

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

David Cockburn, European Qualifi ed Person Association (EQPA)
Member of the EQPA Board of Directors. Former Chair of the EMA GMP/GDP IWG

Dr Darrin Cowley, AstraZeneca, USA (invited)
Head of Developmental Quality, Biologics Quality Lead Covid Vaccine

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

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

Dr Peer Schmidt, AbbVie, Germany (invited)
Director Global Quality Systems

Kristina Smith Hansen, MilCor Consulting, Denmark
Certified quality auditor (GMP/GDP/ISO) and consultant

Niina Taylor, Pfizer, U.K.
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