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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. Read more.

Quality Risk Management / Pharmaceutical Quality System

ICH Q9 Training Course and ICH Q10 and FDA Quality System Training Course.

Budapest, Hungary
21-23 April 2010
 
Find more information here.

EudraGMP DATABASE
Quick link to access the Community database containing information on manufacturers, Manufacturing and Importation Authorisation and GMP Certificates. The read-only access to EudraGMP can be found here (external link).

LATEST GMP NEWS

08/03/2010
Current FDA Procedures for Counterfeit Medicines
The FDA is taking part in an international campaign week in opposition to counterfeit medicines on the Internet. This campaign week has been coordinated by an international working group from WHO to combat counterfeit medicines (IMPACT). You can read more here.

08/03/2010
Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete?
In a recent questions-and-answers paper, the question if, according to cGMP, the manufacture of 3 validation batches is required before a new active pharmaceutical ingredient or medicinal product can be marketed is answered by the FDA in the negative. The reasons for the no can be found here.

08/03/2010
EMA's Inspectors Working Group Publishes Work Plan 2010
An ambitious work plan for EMA's Inspectors Working Group points towards massive changes in the GMP-regulated environment. Here you can read which areas might be concerned.

08/03/2010
FDA Director of Pediatric International Program to speak at ECA Development Conference
Dr Jean Temeck, Director at the FDA Office of Pediatric Therapeutics has confirmed to speak at the 4th ECA Good Development Practice Conference on 18 - 20 May 2010 in Vienna. Read more.

03/03/2010
FDA to speak at ECA Development Conference on Quality by Design
Dr Keith Webber, Deputy Director of the Office of Pharmaceutical Science, CDER, FDA has confirmed to present the FDA Point of View on Quality by Design - at the 4th ECA Good Development Practice Conference taking place from 18-20 May 2010. Read more.

03/03/2010
FDA announces new Programme for a more efficient Inspection of Imports
During a speech on February 4, 2010, Dr. Margaret Hamburg, commissioner of the FDA, introduced a new programme with which the FDA will be able to inspect products for import more effectively and efficiently. From Dr. Hamburg's point of view, measures for the safeguarding of the supply chain ("global supply chain safety") have top priority. You can read more of this speech here.

03/03/2010
EMA publishes "Draft Guideline on Validation of bioanalytical Methods"
To define key elements and provide recommendations for the validation of bioanalytical methods, the EMA published a draft guideline, open to comment until end of May 2010. More details can be found here.

ECA ACTIVITIES

29/07/2009
As of now you can integrate the ECA website into the Google home page (gadget) and in addition use the news as RSS feed. Find out more here.

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.