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This year's annual meeting of the ECA Advisory Board took place in
Heidelberg on 7th July. All eleven members of the panel
representing the pharmaceutical industry and regulatory authorities
attended. The task of the board is to encourage the activities of ECA, the
leading European association in the field of GMP and pharmaceutical
Quality Assurance with more than 3.000 members. Therefore, the yearly
event is used to evaluate ECA's current status and to define future
projects.
The photo shows from left to right:
Mike Edgington, Director for Regulatory Affairs (ECA), Edgington
Associates, The Netherlands; Dr Ludwig Huber, Agilent Technologies,
Germany ; Dr Bernd Renger, Vetter Pharma-Fertigung, Germany; Dr Boris
Pimentel, DSM-Nutritional Products, Switzerland; Matt Moran,
PharmaChemical Ireland, Ireland; Dr Wolfgang Schumacher, F. Hoffmann-La
Roche, Switzerland; Richard Bonner, Associate Partner Concept Heidelberg,
United Kingdom; John Taylor, MHRA, United Kingdom; Daniel Scheidegger,
Chairman of the ECA Advisory Board, Genzyme Pharmaceuticals, Switzerland;
Colin Booth, Oxoid, United Kingdom; Rudolf Völler,
Regierungspräsidium Darmstadt, Germany
Daniel Scheidegger, Chairman of the Advisory Board, assessed the
release of ECA's first Good Practice Guide "FDA cGMP, EU GMP and ISO
9000 Matrix for a Pharmaceutical Quality System" as a milestone in
the effort to create additional benefit for ECA members, "The
feedback that we have received on our GMP Matrix clearly proves that there
is a strong desire in the industry to move towards a harmonised set of GMP
and regulatory guidelines. I am proud that the ECA Advisory Board
anticipated this development at an early stage and that we have defined
our mission accordingly." Just a few days before the Advisory Board
Meeting took place the second revision of the Good Practice Guide was
announced (see GMP News on 30 June
2006).
In addition, the extension of the ECA Certification Programmes and the
founding of the first ECA Working Group on Rapid Microbiological Methods
were further projects that were started during the last year. "The
RMM Working Group is unique in Europe. Our aim is to exchange knowledge
and opinions between industry and regulatory authorities on an expert
level. We have established this team as a non-political, independent,
science based platform to support the application of advanced
microbiological methods in Europe.", said Mike Edgington, Director
for Regulatory Affairs, ECA (see GMP News on 28
July 2006).
The Board was also very pleased with the reception of the newly
introduced webinars. Daniel Scheidegger commented, "The new technique
will help us to organise lectures for a smaller target group on very short
notice. Thus, we can offer information on latest GMP developments even
faster."
At the annual meeting the ECA Advisory Board decided to found the
European QP Association with the objective to represent the Qualified
Persons in Europe. "Being the key person in the quality function of a
pharmaceutical company, the QP has to consider lots of issues to fulfil
his responsibilities and to comply with European legislation," said
Dr Bernd Renger, Director Quality Control at Vetter Pharma-Fertigung GmbH,
Germany, and ECA Advisory Board Member. "Due to the increase and
scope of these responsibilities we saw a need for a Europe wide exchange
forum," he continued. More about this new association can be found at
www.qp-association.eu
Since ECA's foundation in 1999 membership in the association was always
bound to the participation in ECA events. Daniel Scheidegger: "Over
the last years we had to turn down many requests on becoming an ECA member
without taking part in one of our courses and conferences. It seems that
the additional benefits of ECA, especially the GMP
Navigator CD-ROM, convince many people to apply for an ECA
membership. Therefore, the ECA Advisory Board has decided to extent its
membership programme to companies and individuals who have not attended
any ECA event.
At the end of the meeting all Advisory Board Members agreed that the
defined projects will help to promote ECA's objectives to help its members
in complying with current and future GMP requirements.
"I am thankful for the voluntary support ECA has been receiving
from all members of the Advisory Board. During our annual meetings one can
see that we all enjoy working together in this group and that we share the
common interest to provide our colleagues in the industry and at
regulatory authorities with applicable guidance", were the closing
remarks of Daniel Scheidegger.
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