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GMP News No. 926: Annual Review 2006
Annual Review 2006
As in the past years, membership in the European Compliance Academy (ECA)developed very positively. The academy strengthened its reputation as theleading European association with regard to GMP and FDA compliance. Today,we have more than 3.000 members from 50 countries across Europe and abroad.
Foundation of Two New Interest Groups
The year 2006 also marked the foundation of two new interest groups: inJune the ECA established the ECA Rapid Microbiological Methods (RMM)Working Group at the German Federal Agency for Sera and Vaccines. Thisnon-political, independent and science-based group is unique in Europe. Itsgoal is to exchange knowledge and opinions between industry and regulatoryauthorities on an expert level,thereby helping both get a better understanding of the requirements forthe introduction of RMMs and supporting the application of advancedmicrobiological methods in Europe. Currently it counts 11 representativesfrom the European Pharmaceutical Industry and the German Federal Agency forSera and Vaccines, the Paul-Ehrlich-Institute (PEI).
During its annual meeting in July, the Advisory Board decided toestablish the European QP Association. With this membershiporganisation the ECA wants to provide QPs in Europe with a platform allowingthem to exchange experience, discuss latest regulatory requirements, toidentify and address difficulties and challenges and to support a harmonisedEuropean approach. The association is lead by the four ECA Advisory BoardMembers Dr Bernd Renger, Qualified Person, Germany, Richard Bonner,Qualified Person, UK, John Taylor, MHRA, UK, and Rudolf Völler, Office ofthe Darmstadt Administrative District, Germany, as well as Dr ChristopherBurgess, Qualified Person, UK. In November 2006, Dr Bernd Renger was namedChairman of the association.
The interest in the group throughout Europe and beyond underlined theimportance of the newly formed association. More than 150 delegates from 26countries attended its first meeting, the QP Forum held in the fall, toshare experience and discuss the critical areas of the QP's daily work aswell as roles and responsibilities of the Qualified Person withrepresentatives from EMEA and national authorities.
Only six months after its foundation, the European QP Association alreadycounts more than 600 members from more than 30 countries. Find out moreabout the European QP Association.
GMP In-house Training – 2006 another Successful Year
With respect to in-house training courses, the past year tied in with theprevious years. Again, the European Compliance Academy conducted numeroustrainings. We offer this service in cooperation with CONCEPT HEIDELBERG andrely on a pool with high-level speakers who are specialised in various areasand who are professionally, methodically and didactically top qualified –guaranteeing high quality trainings.
CD-ROM "GMP Navigator" – New Release 9.0 under New Name
Traditionally, the GMP Navigator CD-ROM is a very unique anduseful tool. The new release 9.0 was issued in February under the new name"GMP Guideline Manager". Like in the years before, this version containsmore than 800 guidelines from
comprising several thousand pages of regulations. It also holds the FDAWarning Letters from the past 3 fiscal years. Through a comfortable searchfunction users can browse the complete CD content by key words and directlyretrieve guidelines and regulations they are specifically interested in.
The free of charge CD-ROM is an exclusive service for ECA event attendeesand members. Company members receive a multi-user licence of the GMPGuideline Manager software.
GMP Certification Programme – Increasing Awareness
The ECA Certification Programme continued to experience an increasingawareness in 2006. Professionals rely on the high-quality programme toadvance their knowledge and to get an additional qualification – making it aconstant for GMP professionals. Today, ECA offers the followingqualification levels:
As in the previous years we'll further develop the programme to offer newcertifications.
ECA Working Programme 2007
The ECA is based on voluntary work of its members and Advisory Boardmembers. This will not change in 2007.
The following activities are planned for 2007:
Advisory Board Members
Unfortunately, just recently we lost a great friend and true partner inthe ECA Advisory Board. Mike Edgington, aged 54 years, passed away on7 January 2007. We still don't really want to realise this loss and the gaphe leaves, personally and professionally. Apart from his enormous knowledgewhich he employed to make great contributions to ECA activities, Mike wasalways straightforward and very helpful. The founding of the first ECAWorking Group on Rapid Microbiological Methods (RMM) is due to a great dealto his commitment and dedication.
The Advisory Board Members are: