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Ib Alstrup
GxP IT Medicines Inspector with the Danish Medicines Agency (DMA)
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 GLP, GCP, GMP, GDP and GVP areas. He is a co-writer of the new PIC/S guide on Data Integrity and holds a B.Sc. in Electronic Engineering.
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Dr Christopher Burgess
Qualified Person, Chaiman ECA Quality Control Interest Group, UK
Chris has been working in the pharmaceutical industry for many years and is currently among others Chairman of ECA`s Quality Control Interest Group, member of ECA´s Extended Board and member of ECA´s Task Force on Data Integrity.
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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. Before that, he was working for the Bavarian Ministry of Environment and Health. Rainer Gnibl also holds a lectureship at the University Erlangen-Nürnberg.
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Dr Afshin Hosseiny
Qualified Person, Chairman ECA Foundation, Chairman GDP Association, 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.
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Dr Ulrich Kissel
Director Regulatory Affairs, ECA Foundation and Chairman, European QP Association
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.
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Gert Moelgaard
Chairman ECA Validation Group, Denmark
Gert Moelgaard has more than 25 years experience in the pharmaceutical and biotech industry, including several years of experience in process control, automation, computer systems validation and process validation as well as process engineering and consulting. Gert is Chairman of the ECA´s Working Group on Validation and member of ECA´s Extended Board.
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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).
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Mervi Saukkosaari
Senior Pharmaceutical Inspector, Head of Section, Finnish Medicines Agency (Fimea)
Mervi Saukkosaari, pharmacist by profession, is currently Senior Pharmaceutical Inspector at FIMEA. She has more than 20 years experience in the pharmaceutical industry (e.g. Scientist, Group and Project Manager in R &D and Consulting).
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Dr Wolfgang Schumacher
Chairman ECA´s IT Compliance Group, Switzerland
He was Head of the department of Quality Computer Systems at F. Hoffmann-La Roche until July 2017. He is currently Head of ECA´s IT Compliance Group, member of ECA´s Extended Board and member of ECA´s Task Force on Data Integrity.
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Matthew Scherer
FDA Office of International Programs - Europe Office
Assistant Health Attache and International Program and Policy Analyst.
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Lance Smallshaw
UCB Biopharma sprl, Belgium
Lance Smallshaw is Global Director of Analytical Strategy for NBEs at UCB in Belgium and member of ECA´s Executive Board.
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