Speakers and Moderators
GxP IT Medicines Inspector with the Danish Medicines Agency, DMA, Denmark
Ib Alstrup is a GxP IT Medicines Inspector with the Danish Medicines Agency. With a background as a software designer and tester, he has specific focus and large experience in inspection of validation and operation of computerised systems throughout the GxP areas. He is a co-writer of the new PIC/S guide on Data Integrity and holds a B.Sc. in Electronic Engineering.
CSL Behring AG, Switzerland
Peter Flury has more than 35 years experience in the transportation logistics industry in numerous functions with manufacturers and logistics service providers. He is in the pharmaceutical industry since 2008 at CSL Behring and presently in the position as Senior Manager and Head Transportation Management EMEA.
Chairman ECA's Validation Group, Germany
Ralf Gengenbach is founder and managing director of gempex Co. Ltd., Germany. He is member of different organisations, among others DIN UA2 (Board for standards ‘biotechnology’), of DECHEMA and ISPE. He is approved Quality Auditor according to DIN ISO 9000ff. Ralf is currently the Head of ECA´s Validation Group.
Dr Rainer Gnibl
GMP Inspector, District Government of Upper Bavaria, Germany
Dr Rainer Gnibl is pharmacist and GMP Inspector for the District Government and the EMA and performs GMP inspections worldwide. Rainer Gnibl also holds a lectureship at the University Erlangen-Nürnberg.
Thomas Højsholm Schmidt
CSL Behring, Switzerland
Thomas Højsholm Schmidt is Associated Director and Lead Auditor at CSL Behring AG in Switzerland. Before that, he was a GMP Lead Auditor at LEO Pharma A/S in Denmark for over 12 years. Thomas is member of ECA ́s Inspection Group.
Dr Afshin Hosseiny
Qualified Person, Chairman ECA Foundation, UK
Afshin looks back to many years with Glaxo Smith Kline in the UK and is Chairman of ECA´s GDP Interest Group and member of ECA´s Executive Board.
European GDP Association Chairman, UK
Alfred Hunt is a consultant. From 2008 until 2015 he was an Inspector with the Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board (IMB). He was also key member of the European Medici- nes Agency (EMA) drafting group which developed the revised EU GDP Guidelines (2013/C 343/01).
Saddam Huq is Director, Cold Chain and Logistics at GSK.
Dr Rainer Kahlich
Local Government of Baden-Württemberg, Germany
Dr Rainer Kahlich is pharmacist and GMP/GDP Inspector for the Local Government and the EMA and performs GMP/GDP-inspections worldwide.
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). Previous to his current role he held leadership positions in Quality and Supply Chain and served for many years as QP for Roche.
Dr Bernd Renger
Qualified Person, Immediate Past Chairman of the European QP Association, Germany
Bernd worked for many years in the pharmaceutical industry and is Immediate Past Chairman of the European QP Association (EQPA)
Dr Uwe Rettig
Vice President Supply Chain at IDT Biologika GmbH, Germany
Uwe Rettig has joined IDT 2011. With his current position as Head of Supply Chain Management Uwe Rettig is responsible for customer service, planning, and logistics and is in charge of the Sales- and Operations Plannig Process (S&OP).
Dr Peer Schmidt
AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany
Peer Schmidt brings more than 20 years of experience in the development, manufacturing, registration and supervision of Medicinal Products, Medical Devices and Combination Products. As Director Global Quality Systems, he oversees the AbbVie Quality System Centers of Excellence. He also acts as EU Authorized Representative for AbbVie´s Medical Devices. Dr Schmidt holds a Ph.D. in Molecular Biology and was previously the Head of Quality Assurance at Abbott Biotechnology Germany. He is a member of the ICH Q9 Revision 1 Expert Working Group.
Dr Torsten Schmidt-Bader
moveproTEC compliance advisory, Germany
Dr Torsten Schmidt-Bader is Managing Director at moveproTEC and a GMP/GDP lead auditor and compliance advisor. Since 2010 he has been supporting the life science industries and pharma logistic providers with GDP implementation. For SGS ICS, he certified several providers against WHO and EU GDP standards.
Dr Thomas Schneppe
Bayer Bitterfeld GmbH, Germany
Thomas has more than 30 years GMP experience in Pharmaceutical Industry: Qualified Person, Mgmt. Training, GMP Projects, Operational Excellence in different functions at Klöckner Pentapack, Schering AG, Asche AG, Bayer AG and actually Bayer Bitterfeld GmbH.
Dr Wolfgang Schumacher
Chairman ECA´s IT Compliance Group, Switzerland
He was til July 2017 Head of the department of Quality Computer Systems at F. Hoffmann-La Roche. He is currently Head of ECA´s Data Integrity & IT Compliance Group, member of ECA´s Extended Board and member of ECA´s Task Force on Data Integrity
Dr Frank Seibel
Roche Diagnostics GmbH, Germany
Dr Frank Seibel is Quality Site Head at Roche Diagnostics in Mannheim. Before that he was, amongst others, Senior Vice President Corporate Quality & HSE at Aenova Holding and Director Global Manufacturing Quality Strategy at AbbVie.
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.
European Medicines Agency, Netherlands
Andrei Spinei is the team lead for manufacturing in the Inspections Office of the European Medicines Agency. He has joined EMA in 2014 and has since taken up different roles within the manufacturing area, being involved in GMP inspections, market surveillance, international collaboration and policy making. He is also deputy chair for the EU GMP Inspectors Working Group. Andrei holds an MSc. in Pharmacy and before joining the European Medicines Agency he has worked in the Pharmaceutical Industry.
Dr Ingrid Walther
Pharma Consulting Walther, Former Head of the Business Unit iv Drugs, Fresenius
Dr Walther was employed in various positions and has long years of experience in the fields of research and development, QA/QC, and the management of strategic projects and as head of a Business Unit Validation and GMP Compliance Since July 2009 she runs her own business as consultant. She was Head of ECA´s adhoc task force commenting the Annex 1 revision.