ECA's 8th Annual Review (2006)
18 April 2007
Annual Review 2006
Membership – Positive Development and New Opportunities
As in the past years, membership in the European Compliance Academy (ECA) developed very positively. The academy strengthened its reputation as the leading European association with regard to GMP and FDA compliance. Today, we have more than 3.000 members from 50 countries across Europe and abroad.
So far, it was possible to become ECA member through attending a regular ECA course or conference (exception: participation in ECA webinars). Starting in January 2007 this changed – in addition to automatically becoming member by participating in an event, the Academy now also offers two new membership opportunities: individual membership and company membership, including all sites in a country. This started very positive and we already received applications for individual membership and also for company memberships, including applications from internationally operating companies in the first two months of 2007. This big interest also supports the notion of ECA’s impressive reputation. In 2007, we will further promote and advance these opportunities. For instance, global players in the pharmaceutical industry will be able to sign up for worldwide membership, granting all employees around the globe the membership benefits. Due to the company Membership we expect an increase of Members of up to 30% in 2007. Find more information about the new membership opportunitites.
Foundation of Two New Interest Groups
The year 2006 also marked the foundation of two new interest groups: in June the ECA established the ECA Rapid Microbiological Methods (RMM) Working Group at the German Federal Agency for Sera and Vaccines. This non-political, independent and science-based group is unique in Europe. Its goal is to exchange knowledge and opinions between industry and regulatory authorities on an expert level, thereby helping both get a better understanding of the requirements for the introduction of RMMs and supporting the application of advanced microbiological methods in Europe. Currently it counts 11 representatives from the European Pharmaceutical Industry and the German Federal Agency for Sera and Vaccines, the Paul-Ehrlich-Institute (PEI). Find more information about the Rapid Microbiological Methods (RMM) Working Group.
During its annual meeting in July, the Advisory Board decided to establish the European QP Association. With this membership organisation the ECA wants to provide QPs in Europe with a platform allowing them to exchange experience, discuss latest regulatory requirements, to identify and address difficulties and challenges and to support a harmonised European approach. The association is lead by the four ECA Advisory Board Members Dr Bernd Renger, Qualified Person, Germany, Richard Bonner, Qualified Person, UK, John Taylor, MHRA, UK, and Rudolf Völler, Office of the Darmstadt Administrative District, Germany, as well as Dr Christopher Burgess, Qualified Person, UK. In November 2006, Dr Bernd Renger was named Chairman of the association.
The interest in the group throughout Europe and beyond underlined the importance of the newly formed association. More than 150 delegates from 26 countries attended its first meeting, the QP Forum held in the fall, to share experience and discuss the critical areas of the QP's daily work as well as roles and responsibilities of the Qualified Person with representatives from EMEA and national authorities.
Only six months after its foundation, the European QP Association already counts more than 600 members from more than 30 countries. Find out more about the European QP Association.
GMP In-house Training – 2006 another Successful Year
comprising several thousand pages of regulations. It also holds the FDA Warning Letters from the past 3 fiscal years. Through a comfortable search function users can browse the complete CD content by key words and directly retrieve guidelines and regulations they are specifically interested in.
As in the previous years we'll further develop the programme to offer new certifications.
Advisory Board Members
Chairman, European Compliance Academy (ECA)