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. Afshin Hosseiny is also Chairman of the European GDP Association.

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:
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

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.

Gert Mølgaard (Chair, Validation Group)
Gert Mølgaard has more than 25 years experience in the pharmaceutical and biotech industry, including several years in process control, automation, computer systems validation and process validation as well as process engineering and consulting. He has previously worked in Novo Nordisk, Novo Nordisk Engineering and NNE Pharmaplan. From 2009-2012 he was involved in training FDA’s investigators at FDA’s internal training on the 2011 Guidance on Process. Today he runs his own consultancy in Denmark and is Head of the Validation Interest Group.

Dr Tobias Posset (Chair, Visual Inspection Group):
Tobias Posset is heading the Production Support unit in the Pharma Production at Roche Diagnostics, Germany – responsible for in-process control, particle laboratory, automated visual inspection machines and the coordination of the manual inspection training. He was appointed Chairman of the Visual Inspection Interest Group in 2014.

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

Prabjeet Dulai   Prabjeet Dulai
GDP & Quality Matters, UK (Director of Regulatory Affairs and Communication)
Dr Martin Egger   Dr Martin Egger
Pharmaserv, Germany
           
Dr Christian Grothe-Westrick   Dr Christian Grothe-Westrick
B. Braun Avitum
Sue Mann   Sue Mann
Sue Mann Consultancy, UK
           
Dr Laura Ribeiro   Dr Laura Ribeiro
OCP Portugal, Portugal
Saddam Huq   Saddam Huq
GSK, UK
           
Emil Schwan   Emil Schwan
RegSmart Life Science, Sweden
  Alfred Hunt
Hunt Pharma Solutions, Ireland (Deputy Chair of the GDP Association)

 

European QP Association

Dr Susanne DIng   Dr Susanne Ding
Boehringer Ingelheim Pharma, Germany
Qualified Person
Tor Graberg   Tor Gråberg
AstraZeneca, Sweden
           
David Cockburn   David Cockburn
Formerly of EMA, U.K.
Georg Göstl   Georg Göstl
Baxter AG, Austria (part of Takeda) and
Chair of the Austrian QP Association aqpa

 

Pharmaceutical Microbiology Group

Dr David Roesti   Dr David Roesti
Novartis Pharma AG, Switzerland
Arnaud Paris   Arnaud Paris
bioMérieux SA
           
Dr Marcel Goverde   Dr Marcel Goverde
Idorsia Pharmaceuticals Ltd.
Marja Claasen   Marja Claassen
MSD, The Netherlands
           
Olivier Guenex   Olivier Guenec
Sartorius, France
Barbara Gerten   Barbara Gerten
Merck KGaA
           
Dr Ulrich Herber   Dr Ulrich Herber
Charles River
Dr Thomas Meindl   Dr Thomas Meindl
Labor LS SE & Co. KG
           
Dr Johannes Reich   Dr Johannes Reich
MicroCoat Biotechnologie GmbH
     

 

Analytical Quality Control Group

Silviya Dimitrova  

Silviya Dimitrova
Actavis, a Teva Company, Bulgaria

Dr Gerd Jilge   Dr. Gerd Jilge
Boehringer Ingelheim Pharma GmbH & Co. KG Ingelheim, Germany
           
Margarita Sabater   Margarita Sabater
Dako Denmark A/S, an Agilent Technologies Company, Denmark
     

 

Data Integrity and IT Compliance Group

Frank Behnisch  

Frank Behnisch
CSL Behring GmbH, Marburg

Dr Bob McDowall   Dr Bob McDowall
R.D., McDowall Ltd
           
Yves Samson   Yves Samson
Kereon AG, Basel
Michael Wegmann   Michael Wegmann
F. Hoffmann-La-Roche Ltd, Basel

 

Validation Group

Jean-Denis Mallet   Dr Jean-Denis Mallet
NNE Pharmaplan
Dick Bonner   Mr Richard M. Bonner
Qualified Person, Immediate Past Chair of the ECA Foundation
           
Dr Thomas Schneppe   Dr Thomas Schneppe
Bayer Pharma AG
     

 

Visual Inspetion Group

Dr Martin Dearden   Dr Martin Dearden
(formerly PaxVax Berna)
Dr Helmut Gaus   Dr Helmut Gaus
(WinSol; formerly Boehringer Ingelheim)
           
Dr Martin Becker   Dr Martin Becker
(hameln pharmaceuticals gmbh)
Al Goodwin   Al Goodwin
(Amgen SA)
           
Felix Krumbeim   Felix Krumbein
(Roche Diagnostics)
     

 

ATMP Group

Dr Anrea Hauser   Dr. Andrea Hauser
University Hospital Regensburg
Dr Martin Hildebrandt   Prof. Martin Hildebrandt
TU Munich, Germany
           
Niina Taylor   Niina Taylor
Pfizer, Great Britain
Koen Huygens   Koen Huygens
Koen Huygens BVBA, Belgium
           
Dr Hiltrud Horn   Dr. Hiltrud Horn
Horn Pharmaceutical Consulting, Germany
 Tricia Harbinson   Tricia Harbinson
Pfizer, Great Britain
           
Dr Georg Belke-Louis   Dr. Georg Belke-Louis
Apceth, Germany
Dr Hans Henskens   Dr. Hans Henskens
Lonza Netherlands BV