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ABOUT THE EUROPEAN COMPLIANCE ACADEMY

With close to 4,000 members the European Compliance Academy (ECA) has become the leading European association with regard to GMP and regulatory compliance. It was established to facilitate the move towards a harmonised set of GMP and regulatory guidelines by supporting the Pharmaceutical Industry and Regulators through providing information on and interpretation of new or updated guidances.
 
To accomplish its goals, ECA developed a set of tools. In order to learn more about the ECA, please click here.

API CONFERENCE

12th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients. 18-20 November 2009,
Venice, Italy
 
Find more information at www.api-conference.org

LATEST GMP NEWS

01/07/2009
Further CEPs from Chinese and Indian Manufacturers suspended or withdrawn
In addition to the previously announced suspension of five CEPs the EDQM announced further actions. Click here to read more.

01/07/2009
EMEA Draft Transparency Policy published for Consultation
The European Medicines Agency (EMEA) has released a draft transparency policy for public consultation. It sets out how the Agency intends to provide for greater clarity and openness in all areas of its operations. Read more.

01/07/2009
QPs implemented in new Canadian GMP Regulations?
The 2009 Edition of the Canadian GMP Guidelines (GUI-0001) introduces new aspects into the Canadian GMP regulations. When reading some of the new parts one might think that these GMPs are influenced by European GMPs. Read more.

23/06/2009
GMP for Excipients - New Decision of the EU Commission may lead to Misinterpretation
Following the publication of the report on an impact assessment study by an external contractor DG Enterprise and Industry has taken the decision not to continue with the preparation of a Commission Directive on GMP for certain excipients. But this may lead to a wrong interpretation. Here you will find more.

23/06/2009
Series of QP related Q&As published
The European QP Association has published a series of frequently asked questions and the respective answers on their website. Read more.

17/06/2009
New Guidance for Coordination of GCP Inspections published
A Guidance for coordination of GCP inspections and co-operation between GCP inspectors has been published in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures. Read more.

17/06/2009
Quo vadis GMP?
The USA have already made suggestions for updating the US-American GMP rules through their initiative "cGMP for the 21st Century". But what about Europe?

ECA ACTIVITIES

13/10/2008
As the European Compliance Academy (ECA) announced accepted Dr Sven Deutschmann his appointment as new Chairman of its Working Group for Rapid Microbiological Methods (RMM). Read more here.

22/10/2007
In the development of new pharmaceutical products, it is a challenge to design and initiate sound and appropriate clinical studies. A new education course initiated by the ECA now covers all aspects to consider and is supported by the two industry organisations. Find out more here.

14/06/2007
ECA supports a new publication series intended to facilitate the implementation of current GMP guidelines in pharmaceutical operations. The first issue of the "GMP REPORT" covers "FDA Requirements for cGMP Compliance". Twelve Authors from the pharmaceutical industry illustrate the efficient implementation of FDA's cGMP requirements in routine operations. To get more information on the reports and the content of the first issue please see here.

02/04/2007
The Active Pharmaceutical Ingredients Committee (APIC) and the European Compliance Academy (ECA) recently signed a cooperation agreement with the goal to bundle the strengths of the two organisations’ respective areas and to maximise the benefit for the potential target audience in the industry with their activities and conferences. Find out more here.

08/03/2007
Concept Heidelberg has been analysing the FDA Warning Letters on behalf of the European Compliance Academy (ECA) since the fiscal year 2003. Now the new report on the fiscal year 2006 is available as handbook and CD. Get more information here.

19/02/2007
In addition to automatically becoming a member by participating in one of the ECA courses or conferences marked with ECA (exception: Webinars), the Academy now also offers two new membership opportunities - individual membership and company membership.

15/12/2006
The European QP Association, initiated by the ECA in July, announced that it extended its Advisory Board and nominated Dr Christopher Burgess. To find out more, please read here.

15/12/2006
ECA's Working Group on Rapid Microbiological Methods (RMM) experiences tremendous interest. Now the group offers memberships to anyone involved in RMMs. Get the details here.

30/11/2006
ECA's Rapid Microbiology Methods (RMM) Working Group, founded in 2006, currently works on a Best Practice Guide for RMMs. Now the Academy appointed an editorial review board for its guide. Get more information here.