ECA Advisory Board (Foundation Board)
The ECA Advisory Board represents European regulatory authorities as well as the pharmaceutical and biopharmaceutical industry. 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.
The team focuses on the development of new ECA Academy courses and conferences on emerging GMP challenges. The evaluation of all events by the Advisory Board ensures best quality and participant satisfaction.
On 10 July 2015 the ECA Foundation Board decided to establish a new structure of the Board. The new Board is headed by an Executive Team of three members: the Chairman, the Vice-Chairman and the Director Regulatory Affairs. In addition to this team the ECA now has an extended Board where all ECA Groups are represented by their Chairperson – recognising and strengthening their importance. With the further ECA Groups planned each Chair will automatically become member of the extended ECA Foundation Board.
In addition to Executive Board and Extended Board there is a new 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.
Dr Afshin Hosseiny (Chair):
Afshin Hosseiny, who is a Qualified Person via permanent provisions (CPD 2003), looks back at more than 20 years of experience in the pharmaceutical industry in a wide variety of roles with increasing responsibilities – initially in Analytical Services, later in Quality Assurance. He is now Managing Director at Tabriz Consulting in the UK. He was asked to join the Board in 2012.
Lance Smallshaw (Co-Chair):
Lance Smallshaw has 37 years’ experience in Pharma and Biopharm, 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.
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.
Ulrich Kissel (Director Regulatory Affairs, European QP Association):
In addition to becoming the ECA Foundation’s Director Regulatory Affairs in 2017 (see above), he also became Advisory Board Chairman of the European QP Association.
Dr Sven Deutschmann (Chair, Pharmaceutical Microbiology Working 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 Working 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 Afshin Hosseiny (Chair, GDP Interest Group):
Besides his Co-Chairmanship in the ECA Foundation’s Executive Board (please see above) Afshin Hosseiny has been Chair of the GDP Interest Group since its start in 2013.
Dr Wolfgang Schumacher (Chair, DI & IT Compliance Interest 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 DI & IT Compliance Interest Group which was established in 2015.
Gert Mølgaard (Chair, Validation Interest 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 Interest 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 Andrea Hauser (Chair, ATMP Interest Group):
Andrea Hauser is Head of Operations, Head of Production and Head of Quality Assurance at the Jose-Carreras-Centre for Somatic Cell Therapy, a department of the University Hospital Regensburg. She studied Pharmacy at the University of Regensburg. After that she was working as a GMP inspector at the Government of Upper Bavaria in Munich, where she conducted numerous GMP and GCP inspections mainly in the field of blood, tissue and (stem) cell therapy. Dr Hauser holds the qualification to act as Qualified Person. She was appointed Chairman of the ATMP Interest Group in 2017.
Richard M. Bonner
Immediate Past Chair of the ECA Foundation