In order to do justice to the quickly-growing number of members, on 15 July 2001 Dr Peter Reichelt, Managing Director of Reichelt Chemietechnik, was appointed Chairman of the European Compliance Academy. From 2005 through 2011, Daniel Scheidegger, Vice President Operations and Managing Director of Genzyme Pharmaceuticals Liestal, chaired the ECA Advisory Board. In April 2012, Richard Bonner, independent consultant in the UK followed as Chairman due to the untimely death of Daniel Scheidegger in September 2011. The ECA Chairman is elected by the Advisory Board for a period of 2 years. After this period, a new Chairman can be named, or the same Chairman can be re-elected.
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 are two Advisory Committees. Neither of these Committees is part of the ECA Foundation legal structure in order to avoid a conflict of interest.
The first Advisory Committee comprises members from EU GMP Inspectorates and from EU Authorities. The second Advisory Committee consists of members from other industry interest groups.
This setup allows the ECA Foundation Board to involve colleagues from other industry groups and authority representatives for certain discussions on a case by case basis. As their members are not part of the legal structure they can remain independent with regard to any ECA publication, comment or position paper – e.g. when the ECA is commenting on new regulations or when the ECA is publishing Best Practice Papers.
Please find the new Board structure as well as information on the members below:
Richard M Bonner (Chair):
Dick Bonner is a Qualified Person and has 31 years of experience within the pharmaceutical industry, working in production, technical services and both Quality Control and Quality Assurance functions. Today he runs his own consultancy in the UK. He has been member of the ECA Foundation Advisory Board since 2002 and succeeded Daniel Scheidegger as Chairman in 2012.
Dr Afshin Hosseiny (Co-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 (Director Regulatory Affairs):
Lance Smallshaw is Global Director of Analytical Strategy for NBEs at UCB in Belgium. He has more than 25 years experience in Analytical Development and QC Laboratories. He is one of the original conception members of the UK Pharmaceutical Analytical Science Group (Pasg) Biopharmaceutical Working Group and currently is their honorary secretary. He was nominated for the Advisory Board in 2013.
Richard M Bonner (Chair, European QP Association):
In addition to becoming the ECA Foundation Advisory Board Chairman in 2012 (see above) he also took over the chairmanship of the
QP Interest Group in the same year.
Dr Sven Deutschmann (Chair, RMM Interest 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
RMM Working Group since its foundation 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, Computer Validation Working Group):
Following various positions at Asta Medica, Wolfgang Schumacher joined F. Hoffmann-La Roche in Switzerland in 2001. There he is now Head of the Department of Quality Computer Systems. He was appointed to the ECA Foundation’s Board in 2002 and now leads the Computer Validation Interest Group which was established in 2015.
Dr Jean-Denis Mallet (Chair, Validation Working Group):
Jean-Denis Mallet was Head of the Pharmaceutical Inspection Department at the French Authority (Afssaps). He also has extensive industry experience in various positions, including Quality Assurance, Production Management and Engineering. Today he is a GMP Consultant at NNE Pharmaplan in France. He joined the Advisory Board in 2010 and is now Head of the
Validation Working 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.