Independent Authority Board (IAB) Members
Since June 2015 the ECA Foundation, the leading European organisation in the pharmaceutical quality assurance and GMP compliance environment, has been managed by an Executive Board and an Extended Board. In addition, the ECA set up an Advisory Committee encompassing authority representatives.
It is one of the ECA Foundation’s major objectives to discuss GMP developments with the stakeholders in industry, academia and authorities. For authority representatives any potential conflict of interest must be avoided. Therefore the ECA invited members of authorities to join the newly set up Independent Authority Board (IAB). This Board is not involved in any of the ECA activities, and its members are not part of the Foundation’s legal structure. This setup therefore now allows individual authority representatives to personally decide to get involved in discussions on a case by case basis. It also enables them to 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.
The newly set up Independent Authority Board comprises the following members:
- Dr Rainer Gnibl, Government of Upper Bavaria, Germany
- Andreas Kraßnigg, AGES (Austrian Agency for Health and Food Safety), Austria
- Dr Claudius Micha Nübling, Paul-Ehrlich-Institute, German Federal Agency for Vaccines and Biomedicines
- Dr Isabelle Bekeredjian-Ding, Paul-Ehrlich-Institute, German Federal Institute for Vaccines and Biomedicines
- Dr Matthias Heuermann, LIGA.NRW, Germany
- Johanna Linnolahti, Fimea Finland
- Karl-Heinz Menges, Regional Council Darmstadt, Germany
- Dr. Ralf Sanzenbacher, Paul-Ehrlich-Institute, German Federal Agency for Vaccines and Biomedicines
- Jan-Oliver Karo, Paul-Ehrlich-Institute, German Federal Agency for Vaccines and Biomedicines
New structure paves way for future activities
Since its beginning in the year 1999 the ECA Foundation has developed like no other European organisation in the field of GMP compliance and pharmaceutical Quality Assurance. In mid 2015 the ECA Foundation therefore established the Executive Team with the Chairman, the Vice-Chairman and the Director Regulatory Affairs, the Extended Board with the various ECA Interest and Working Groups’ Chairmen and the aforementioned Independent Authority Board (IAB) as a new Advisory Committee.
With the Extended Board the Foundation intended to recognise and strengthen the Groups’ increasing importance and allow them to be directly involved in defining and planning ECA activities. Today the seven Interest and Working Groups build the broad basis for these activities:
- The European Qualified Person Association (Interest Group)
- The Pharmaceutical Microbiology Group (Working Group)
- The Analytical Quality Control Group (Working Group)
- The Validation Group (Interest Group)
- The Good Distribution Practices (GDP) Group (Interest Group)
- The Visual Inspection Group (Interest Group)
- The DI & IT Compliance Group (Interest Group)
- The ATMP Group (Interest Group)
These groups’ goal is to actively drive various activities in specific areas – like organising trainings, conducting surveys to provide feedback to guideline drafts, writing Good Practice Guides or white papers.
In addition the ECA Foundation has established Europe’s largest Academy for GMP professionals – with annually more than 70 GMP events organised in 10 EU countries. Also, only in 2015 the Academy organised and conducted more than 50 in-house training courses for companies and European Authorities. And the trend is showing a further increase. Today the advanced training provider counts close to 4.000 members, and the number is still increasing.
Please find the ECA Foundation Executive and Extended Board with the Independent Authority Advisory Board below (if you click on the image you will get a larger version).