Speakers and Moderators
David Abraham
Head of ECA´s European GMP Auditor Association, UK
David works as an independent quality consultant with Quality Resource Solutions Associates in UK and has extensive experience in both business and Quality Management system development.
Ib Alstrup
Danish Medicines Agency, DMA, Denmark
Ib Alstrup is a GxP IT Medicines Inspector with the Danish Medicines Agency.
David Cockburn
European Qualified Person Association (EQPA)
David Cockburn is a member of the EQPA Board of Directors and former Chair of the EMA GMP/GDP IWG.
Ralf Gengenbach
ECA Validation Group, Germany
Ralf Gengenbach is founder and managing director of gempex Co. Ltd., Germany. He is currently the Head of ECA´s Validation Group.
Dr Afshin Hosseiny
ECA Advisory Board, U.K.
Dr Hosseiny looks back to many years with Glaxo Smith Kline in the UK and is member of ECA´s Executive Board.
Dr Ulrich Kissel
European QP Association, Germany
Ulrich Kissel is Qualified Person and Chairman of the Board of Directors of the European Qualified Person Association (EQPA).
Dr Peer Schmidt
AbbVie, Germany
Peer Schmidt is Director Global Quality Systemy at AbbVie and acts as EU Authorized Representative for AbbVie´s Medical Devices.
Dr Franz Schönfeld
GMP Inspector, Germany
Dr Franz Schönfeld is a GMP and GDP inspector at the local inspectorate for medicinal products and active substances of the District Government of Upper Franconia.
Dr Wolfgang Schumacher
ECA IT Compliance Group, Switzerland
Dr Schumacher was Head of the department of Quality Computer Systems at F. Hoffmann-La Roche and is currently Head of ECA´s Data Integrity & IT Compliance Group.
Lance Smallshaw
UCB Biopharma S.A., Belgium
Lance Smallshaw is Global Analytical and Quality Expert – Head of Compendial Affairs at UCB in Belgium and Member of ECA´s Executive Board.
Dr Jörg Stüben
Boehringer Ingelheim International, Germany
Head of Regulatory Information Management and Senior Expert. He is responsible for a RIM group.
Oleksandra Bakhurynska
Farmasoft LLC., Ukraine
She has 15 years of experience in the pharmaceutical industry, including implementing pharmaceutical quality systems, quality control, ISO 9001:2015, obtaining wholesale distribution licenses, and passing inspections to acquire GDP and ISO 9001:2015 certifications.
Martin Egger
Pharmserv, Germany
CEO and experienced manager in the biotech and pharmaceutical industry.
Michael Fleischer
Roche Pharma, Germany
GDP Expert at Roche Pharma AG and certified Senior Lead Auditor in various industries.
Tina Geyer
Pfizer Pharma, Germany
Associate Director Quality & Responsible Person and Lean Six Sigma Black Belt at Pfizer Oncology
Alfred Hunt
Hunt Pharma Solutions, Ireland and European GDP Association Chairman
Consultant. He was an Inspector with the Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board (IMB).
Saddam Huq
GlaxoSmithKline, U.K.
Saddam Huq is Director, Cold Chain and Logistics at GSK
Robert Kayum
DD, U.K.
Head of Quality Assurance with over 15 years’ experience as an RP and a wealth of knowledge and experience in various aspects of Good Distribution Practice.
Dr Zvonimir Majic
IATA Senior Consultant for Healthcare, Croatia
Dr Zvonimir Majic is former Global Director for supply chain quality assurance and GDP in Teva Pharmaceutical Industries Ltd.
Sue Mann
Sue Mann Consultancy, U.K.
Sue Mann has spent over 35 years in the industry in various roles including technical support, clinical trial supplies and quality assurance/management.
Dr Daniel Müller
GMP/GDP Inspectorate, Local Government, Germany
Daniel Müller is head of the GMP Inspectorate at the local competent authority in Tuebingen, Germany.
Dr Torsten Schmidt-Bader
moveproTEC compliance advisory, Germany
Managing Director at moveproTEC and a GMP/GDP lead auditor and compliance advisor.
Emil Schwan
Swedish Medical Products Agency, Sweden
Pharmaceutical Inspector at MPA and former Senior Consultant for RegSmart Life Science AB.
Mateusz Zawadzki
IATA, Croatia
Product Manager with years of experience in Special Cargo Supply Chain Management.