Speakers

Speakers from Authorities, Inspectorates amd Associations

Dr Rainer Gnibl, Government of Upper Bavaria, Germany
GMP Inspector for the District Government and the EMA, Advisory Board member of EQPA

Dr Nils Jost, Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Germany
Scientific Expert Antibody Therapeutics

Mag.pharm. Andreas Kraßnigg, Austrian Agency for Health and Food Safety (AGES), Austria
Head Pharmaceutical Inspections and Member of Annex 16 Drafting Group, Chair of the PIC/S Sub-Committee on Expert Circles and Advisory Board member of EQPA

Gillian Renouf, Royal Pharmaceutical Society QP Assessment Panel, U.K.
Chair of the RPS QP Assessment Panel

Dr Franz Schönfeld, Government of Upper Franconia
GMP Inspector for the District Government and the EMA

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 Qualified Person Association (EQPA)
Member of the EQPA Board of Directors. Former Chair of the EMA GMP/GDP IWG

Dr Susanne Ding, Boehringer Ingelheim, Germany
Qualified Person for Investigational Medicinal Products 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

Paulien Groll, Takeda, USA
Head of Compliance Excellence (VP), Global Quality Compliance & Enterprise Systems

Arnoud Herremans, Y47 Consultancy, Netherlands
Lean Kaizen Coach

Katrien Himpens, Janssen, Belgium
Qualified Person IMP, Senior Director QA Clinical Supply Chain

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 and Head of Quality Compliance and Systems Biologics Operating Unit, Member of the IMP Working Group within the EQPA

Kelly Jenner, Pfizer, U.K.
Senior Manager QA Compliance

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

Sandra Moricz, Sanofi, Austria
Deputy Country Quality Head Austria, Qualified Person for Sanofi in Austria

Dr Tilman Rock, Boehringer Ingelheim RCV, Austria
Senior Vice President and Site Head Biopharma Austria

Dr Frank Seibel, Roche Diagnostics, Germany
Quality Site Head

Robert Schwarz, FH Campus Vienna, Austria
University lecturer, freelancing trainer and consultant

Dr Andreas Schwinn, Roche Pharma AG, Germany
Senior Qualified Person

Maria Söderblom, AstraZeneca, Sweden
Director Quality Assurance and Qualified Person

Niina Taylor, Pfizer, U.K. and Ireland
Director Quality Assurance and Qualified Person, Member of the IMP Working Group within the EQPA

Brenda Van Assche, Janssen Pharmaceutica NV, Belgium
Site Quality Head / Qualified Person IMP, Member of the IMP Working Group within the EQPA

Bart Vannieuwenhuyse, Janssen, Belgium
Data Science Lead for Janssen R&D

x