ECA Foundation announces new board structure

On June 10, 2015, the ECA Foundation's Board set the course for the future – with a new Board structure. While the ECA Foundation's Board previously consisted of 10 experts from industry and authorities, it is now led by a new management team with three members: the Chairman, the Vice Chairman, and the Director of Regulatory Affairs. In addition to this team, the ECA now also has an expanded Board, the so-called Extended Board. In this advisory board, the various ECA interest and working groups are represented by their chairs. This new structure takes into account and at the same time strengthens the increasing importance of these groups. It also enables them to actively participate in the definition and planning of ECA activities. With the founding of each new ECA group, its chair automatically becomes a member of the extended advisory board.

In addition to the Executive and Extended Boards, there are also two new advisory committees. To avoid conflicts of interest for their members, however, none of the members of these two committees are part of the legal structure of the ECA Foundation.

The first advisory committee includes members from EU-GMP inspectorates and EU authorities. The second advisory committee consists of members from other stakeholder groups within the industry. This setup allows the ECA Foundation Board, on a case-by-case basis, to involve representatives from other industry organizations or authorities for specific discussions. Furthermore, they can remain independent regarding all ECA publications, comments, or position papers – e.g., when commenting on new regulations or publishing ECA Best Practice Papers.

New structure due to rapid growth

Since its beginnings in 1999, the ECA Foundation has developed like no other organization in the field of GMP compliance and pharmaceutical quality assurance. Today, the organization comprises six interest and working groups that form the broad basis for its activities:

The European Qualified Person Association (Interest Group) – 2,300 members
The Rapid Microbiological Methods (RMM) Group (Interest Group) – 450 members
The Analytical Quality Control Group (Working Group) – 143 members
The Validation Group (Working Group) – 27 members
The Good Distribution Practices (GDP) Group (Interest Group) – 410 members
The Visual Inspection Group (Interest Group) – 535 members

The Computer Validation Group – in formation

The goal of these groups is to engage experts from industry and authorities for various activities in specific areas – such as organizing training sessions, conducting surveys to gather feedback on draft guidelines, or writing Good Practice Guides or Whitepapers.

Furthermore, the ECA Foundation has established Europe's largest academy for GMP professionals and executives – with over 70 open GMP events annually in 10 EU countries. In addition, in 2014, the ECA Academy organized and conducted over 50 in-house training sessions for companies and European authorities.

And the trend for 2015 and 2016 shows further growth. The ECA Academy also enables interested individuals to become members, e.g., to participate in the ECA Certification Program. Today, the training provider has more than 4,000 members – with an increasing trend.

About the ECA Foundation

Founded in 1999 as an independent non-profit organization, the ECA Foundation is now Europe's leading organization in the field of pharmaceutical quality assurance and GMP compliance. The foundation's goal is "the exchange of information between representatives from industry, authorities, and universities in the field of pharmaceutical quality assurance, especially regarding Good Manufacturing Practice (GMP)." To this end, the organization has established various interest and working groups as well as an academy for further education. Individuals can become members of both the ECA groups and the academy. Overall, the ECA organization now has over 7,000 members. The largest group, the European Qualified Person Association, alone has more than 2,300 members. The groups of the ECA Foundation have developed a range of tools – such as some Good Practice Guides or the GMP Guideline Manager CD. For more information about the ECA Foundation, please visit www.eca-foundation.eu.

About the members of the Executive and Extended Board

Executive Board

Richard M Bonner (Chair):
Dick Bonner is a Qualified Person with 31 years of experience in the pharmaceutical industry (including Eli Lilly and Company UK and USA). There, he worked in production, technical services, and various functions in both quality control and quality assurance. Today, he is based as a GMP consultant in the UK. He has been a member of the ECA Foundation Board since 2002 and succeeded Daniel Scheidegger as ECA Chairman in 2012.

Dr. Afshin Hosseiny (Co-Chair):
Afshin Hosseiny, Qualified Person, has 20 years of experience in the pharmaceutical industry – in various positions and responsibilities (including at Glaxo UK), initially in analytics, later in quality assurance. He is currently Managing Director at Tabriz Consulting in the UK. He was appointed to the board in 2012.

Lance Smallshaw (Director Regulatory Affairs):
Lance Smallshaw is Global Director, Analytical Strategy for New Biological Entities (NBEs) at UCB in Belgium. He has over 25 years of experience in analytical development and QC laboratories. He is also a founding member of the "UK Pharmaceutical Analytical Science Group (PASG) Biopharmaceutical Working Group" and currently its honorary Secretary. He was nominated for the ECA Board in 2013.

Extended Board

Richard M Bonner (Chair, European QP Association):
In addition to his appointment as Chairman of the ECA Foundation Advisory Board in 2012 (see above), he also took over the leadership of the European QP Association in the same year.

Dr. Sven Deutschmann (Chair, RMM Interest Group):
Sven Deutschmann has been with Roche Diagnostics since 1995 and is currently Director of the QC Department for Microbiology and Cell Biology in the Pharma division. He is also a member of various national and international pharmacopoeia expert groups. As a member of the RMM Working Group since its founding in June 2006, he was appointed its third Chairman in 2008.

Dr. Christopher Burgess (Chair, Analytical QC Working Group):
Chris Burgess has over 30 years of experience in the pharmaceutical industry, mainly in quality assurance and analytical R&D (including Glaxo UK). He is a Qualified Person and official assessor for ISO 17025, with extensive experience in applying statistical methods for data interpretation and analysis. With the founding of the Analytical QC Working Group in 2010, he became its Chairman.

Dr. Afshin Hosseiny (Chair, GDP Interest Group):
In addition to his appointment as Co-Chairman of the ECA Foundation Executive Board (see above), Afshin Hosseiny has also been leading the Good Distribution Practice (GDP) Interest Group as Chair since its inception in 2013.

Dr. Wolfgang Schumacher (Chair, Computer Validation Working Group):
After various positions at Asta Medica, Wolfgang Schumacher joined F. Hoffmann-La Roche in Switzerland in 2001. He is currently head of the Quality Computer Systems department. He was appointed to the ECA Foundation Board in 2002 and is Chair of the newly established Computer Validation Interest Group since 2015.

Dr. Jean-Denis Mallet (Chair, Validation Working Group):
Jean-Denis Mallet was head of the "Pharmaceutical Inspection Department" at the French regulatory authority Afssaps. He also has extensive experience from various industry positions, including in quality assurance, production management, and engineering. Today, he is a GMP consultant at NNE Pharmaplan in France. He joined the ECA Foundation Advisory Board in 2010 and is Chair of the Validation Working Group.

Dr. Tobias Posset (Chair, Visual Inspection Interest Group):
Tobias Posset heads the Production Support Department at Roche Diagnostics in the Mannheim pharmaceutical site and is responsible for in-process control, the particle laboratory, systems for automatic visual inspection, and training coordination for manual visual inspection. He was appointed Chairman of the Visual Inspection Interest Group in 2014.