The ECA Foundation Team
The ECA Foundation Team consists of experts from the pharmaceutical and biopharmaceutical industry. These experts serve as Advisory Board Members in the different Interest and Working Groups of the ECA Foundation. The leadership of the ECA Foundation and its Interest and Working Groups is represented by the Executive Board (also called Foundation Board). By their voluntary work, the board members support the ECA Foundation in fulfilling its mission to impart most relevant knowledge on the interpretation and implementation of GMP and regulatory requirements.
In addition to Advisory Board there is an Independent Authority Advisory Committee. Its members from EU GMP Inspectorates and from EU Authorities are not part of the ECA Foundation legal structure in order to avoid a conflict of interest.
The ECA Executive Board (Foundation Board)
Dr Afshin Hosseiny (Chair):
Afshin Hosseiny, formerly Director of Quality Assurance for the Global Supply Network of GSK, is an independent consultant supporting companies within the pharmaceutical and biotechnology supply chain. Afshin is a QP via permanent provision looks back at over 36 years of experience in the pharmaceutical industry in a wide variety of roles in increasing responsibilities – he conducts audits of manufacturing sites across Europe and USA, as well as preparation for and fronting of EU and FDA regulatory inspections. Afshin is an acknowledged expert in quality management system for pharmaceutical supply chain, he is a regular speaker at pharmaceutical industry conferences.
Lance Smallshaw (Co-Chair):
Lance Smallshaw has 37 years’ experience in Pharma and Biopharma, Worldwide Analytical and Strategies Expert at UCB Biopharma, based in Belgium, working in the Corporate Analytical Sciences Team. Working in Regulatory Intelligence and developing company worldwide policy for new regulatory requirements. Developed company strategy and oversaw the worldwide implementation of ICH Q3D. He was nominated for the Advisory Board in 2013. Lance Smallshaw further chairs the Cannabis Working Group.
Dr Ulrich Kissel (Director Regulatory Affairs):
Ulrich Kissel is Qualified Person and Member of the Board of Directors of the European Qualified Person Association (EQPA). He works as a GMP consultant and contract QP to the Pharmaceutical Industry. Previous to his current role he held leadership positions in Quality and Supply Chain and served for many years as QP for Roche. He also heads the European QP Association as Chairman.
David Cockburn has extensive experience in the Pharma Industry, having worked for five years at GD Searle and Glaxo Operations in regulatory affairs and manufacturing roles respectively. He joined UK’s MHRA as a Principal Medicines Inspector conducting inspections in UK and globally for 14 years. He then joined the European Medicines Agency (EMA), with a number of GMP-related roles becoming Head of Manufacturing and Quality Compliance and consequently Chair of the GMP/GDP Inspectors Working Group. He is also member of the Advisory Board of the European QP Association.
The Chairs of the ECA Interest Groups
Alfred Hunt (Chair, GDP Association):
Alfred Hunt has extensive experience in various roles in both medicinal products and medical devices. He is a consultant working in the GDP and GMP area for more than six years. 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 Medicines Agency (EMA) drafting group, which developed the revised EU GDP Guidelines (2013/C 343/01). Prior to being employed with the HPRA he held various positions within the medicinal product and medical devices industries in Ireland. He is a Chemical Engineer by training. Alfred Hunt was appointed as Chairman of the GDP Association in June 2022.
Dr Sven Deutschmann (Chair, Pharmaceutical Microbiology Group):
Sven Deutschmann has been with Roche Diagnostics since 1995 and is now Director of the Micro- and Cellbiology QC Department in the Pharma Division. He is also member of several national and international Pharmacopoeial Expert Groups. As member of the Pharmaceutical Microbiology Group since its foundation as originally Rapid Microbiological Methods (RMM) Group in June 2006 he was appointed as the group’s third Chairman in 2008.
Dr Christopher Burgess (Chair, Analytical QC Group):
Chris Burgess has more than 30 years of experience in the pharmaceutical industry, mostly in quality assurance and analytical R&D. He is a Qualified Person and official assessor for ISO 17025 and has extensive experience in the application of statistical methods for data interpretation and analysis. He was appointed Chairman of the Analytical QC Working Group with its inception in 2010.
Dr Wolfgang Schumacher (Chair, DI & IT Compliance Group):
Following various positions at Asta Medica, Wolfgang Schumacher joined F. Hoffmann-La Roche in Switzerland in 2001. There he has been Head of the Department of Quality Computer Systems until August 2016. He was appointed to the ECA Foundation’s Board in 2002 and now leads the Data Integrity & IT Compliance Interest Group which was established in 2015.
Ralf Gengenbach (Chair, Validation Group)
Ralf is founder and managing director of gempex, a full services provider for implementing, optimising and maintaining quality assurance systems around the world, headquartered in Germany. He is member of several organisations (e.g., ISPE, PDA, SAQ, BAH), president of the supplier association VIP3000 and also was actively engaged in the past in the DIN UA2 (Board for standards 'biotechnology'), and the DECHEMA validation group. He continues to be active as a 3rd party auditor worldwide. In November 2021 he became head of the Validation Interest Group.
Felix Krumbein (Chair, Visual Inspection Group):
Felix Krumbein studied optotechnics and image processing and initially worked on the development of GMP-compliant image processing systems. He was head of Inspections-Systems-Support at Roche Mannheim, where he was responsible for the qualification of visual inspection systems. Since 2022 he is Head of Visual Inspection at INSPECTIFAI / Körber AG, where he is responsible for the development and implementation of AI-based solutions for fully automated inspection machines. He became Chairman of the Visual Inspection Interest Group in 2022.
Dr Sabine Hauck (Chair, ATMP Group):
Sabine Hauck has nearly 20 years of experience in drug product development and held various positions in the field of development, quality assurance and regulatory affairs in small to midsize biotech and pharma companies, respectively. Prior to her industry career in drug product development, she was a scientist in biosensor development at Fraunhofer. Currently Sabine Hauck is Vice President Research & Development at Munich-based biotech company Leukocare. Within LEUKOCARE she is responsible for the research & development activities of the company. Sabine Hauck is Chairman of the ATMP Interest Group.
The Advisory Board Members of the ECA Interest Groups
European GDP Association
|Dr Martin Egger
|Dr Christian Grothe-Westrick
B. Braun Avitum
Sue Mann Consultancy, UK
|Dr Laura Ribeiro
OCP Portugal, Portugal
European QP Association
|Dr Susanne Ding
Boehringer Ingelheim Pharma, Germany
Formerly of EMA, U.K.
Baxter AG, Austria (part of Takeda) and
Chair of the Austrian QP Association aqpa
Pharmaceutical Microbiology Group
|Dr David Roesti
Novartis Pharma AG, Switzerland
|Dr Marcel Goverde
Idorsia Pharmaceuticals Ltd.
MSD, The Netherlands
|Dr Ulrich Herber
|Dr Thomas Meindl
Labor LS SE & Co. KG
|Dr Johannes Reich
MicroCoat Biotechnologie GmbH
Analytical Quality Control Group
|Dr. Gerd Jilge
Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim, Germany
Dako Denmark A/S, an Agilent Technologies Company, Denmark
Data Integrity and IT Compliance Group
|Dr Bob McDowall
R.D., McDowall Ltd
Kereon AG, Basel
F. Hoffmann-La-Roche Ltd, Basel
|Dr Jean-Denis Mallet
|Mr Gert Moelgaard
|Dr Thomas Schneppe
Bayer Pharma AG
Visual Inspetion Group
|Dr Martin Dearden
(formerly PaxVax Berna)
|Dr Helmut Gaus
(WinSol; formerly Boehringer Ingelheim)
|Dr Martin Becker
(hameln pharmaceuticals gmbh)
|Dr Tobias Posset
|Dr. Andrea Hauser
University Hospital Regensburg
|Prof. Martin Hildebrandt
TU Munich, Germany
Pfizer, Great Britain
Koen Huygens BVBA, Belgium
|Dr. Hiltrud Horn
Horn Pharmaceutical Consulting, Germany
Pfizer, Great Britain
|Dr. Georg Belke-Louis
|Dr. Hans Henskens
Lonza Netherlands BV