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ABOUT THE ECA FOUNDATION

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.

DATABASES ON GMP INSPECTIONS

NEW: FDA Warning Letter Tree

EudraGMP database (EMA)

WHO inspections (WHOPIR)
In a “Concept Paper” from 2010 the European Medicines Agency (EMA) announced that they would revise their Note for Guidance on Process Validation from 2001. This revision’s goal is to implement modern aspects (“enhanced approach”) to move towards a “continuous process verification.

To find out what the industry thinks about this approach, the European Compliance Academy (ECA) conducted a survey in September 2011. More than 500 professionals provided their input to the survey. The results were mailed to the EU Commission and the EMA. Here you will find this letter summarising the survey results.

NEW
Two videos will allow you to get an impression about the ECA Foundation and its comprehensive services as well as about the social events as part of every course and conference - providing the ideal platform for exchanging experience and for networking. Please go here the watch the videos.

LATEST GMP NEWS

16/05/2012
EMA - Regulatory procedural Advice on similar biological medicines
In April, the European Medicines Agency published a new document on regulatory procedural advice on similar biological medicines. This guidance should provide help for the applicants to submit applications, which are in conformity with the legal and regulatory requirements. More details can be found here.

16/05/2012
EMA strengthens Oversight on Clinical Trials outside EU
The European Medicines Agency (EMA) has published the final reflection paper concerning ethical and good clinical practice (GCP) aspects of clinical trials conducted outside of the European Union (EU)/European Economic Area (EEA). Read more.

16/05/2012
Interesting USP Validation Documents - Available Online free of Charge!
The USP has put new standards online and for free in the Medicines Compendium. In doing so, the USP wants to contribute to improve the quality of starting materials and medicinal products worldwide. This includes monographs for APIs and medicinal products, General Chapters and even data on the validation of the analytical methods used. Read more in this News.

16/05/2012
Foundation of a new French Health Regulation Authority
The existing French health authority has been re-organised. The AFSSAPS has been replaced by the ANSM (Agence nationale de sécurité du médicament et des produits de santé). Read on.

16/05/2012
Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier?
Bulk products used in the manufacturing of medicinal products are subject to the same GMP regulations as APIs and finished products regarding storage and transport. The respective guidelines only provide unclear information about the data required for the application dossiers. The EMA has now closed this loophole with the publication of a Questions and Answers document. Read more.

16/05/2012
New USP Chapter on Method Transfer effective
The method transfer is a documented process which establishes the evidence that a laboratory is qualified to use an analytical method which has been elaborated in another laboratory. Hereby the evidence must be brought that the laboratory has the knowledge and the ability to perform the analytical method as intended. The USP 35 now includes a new General Chapter <1224>. Read more here in the News.

16/05/2012
Development and Manufacturing of APIs: Final ICH Q11 Document Published!
One year after the publication of the Draft Consensus Guideline ICH Q11 "Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)", the finalised document has been released. Read more here about the new guideline.

ECA ACTIVITIES

14/06/2010
The ECA and the European QP Association are currently evaluating the possibility of running training courses on European GMP requirements and the role of the QP outside Europe, amongst others in the U.S.A. Please read more here.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the ECA Foundation (see also News from 14 April 2010) - comprising a non-profit educational organisation, the ECA Academy, and two non-profit interest groups. To get an update on the latest developments with regard to the ECA, please see the video address of Daniel Scheidegger, ECA Foundation Chairman - here.

04/05/2010
To allow students to attend ECA Conferences and Education Courses, the ECA Foundation now offers a Student Programme with special fees. Read more here.

21/04/2010
European Compliance Academy (ECA) nominates Dr Jean-Denis Mallet as new Advisory Board Member. Please see here for more information.

14/05/2010
With the beginning of 2010 the European Compliance Academy (ECA) was transferred to the "ECA Foundation". Get the details here.

30/03/2010
For 2010 the ECA Working Group on Rapid Microbiological Methods (RMM) has planned various activities. To find out more about the planned programme, please read here.

24/03/2010
In April 2008 the European QP Association started its shared audits initiative. Now the Association released its new database "QPSHARE", enabling QPs to find potential partners for sharing audits more easily. Read more here.

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.