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About ECA

  

Table of Contents

 

 

 

What Is ECA?

  
     
 

On the 1st of January 1999 the European Compliance Academy was founded. The European Compliance Academy (ECA) is an independent not-for-profit organisation chaired by a Scientific Advisory Board with 11 members of the pharmaceutical industry and regulatory authorities.

With more than 3,000 members, ECA has become the leading European association with regard to pharmaceutical Quality Assurance and GMP compliance. The members from all over Europe and abroad represent 45 countries.  

The ECA does not employ any staff. ECA relies on voluntary work. An image folder about ECA can be found here.

  
     
 

ECA's Mission

  
     
  "The ECA will provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances".

This includes among others:

  • The development of the GMP Guideline Manager Software with annual update of all GMP-relevant regulations issued by the most important medicines authorities and organisations worldwide
  • Providing an Internet platform (www.gmp-compliance.org) for research on and interpretation of the regulations regarding pharmaceutical quality assurance and regulatory compliance
  • The development of GMP tools aiming at the fulfilment of GMP requirements defined by various regulatory authorities (e.g. GMP Matrix)
  • The organisation of education courses and conferences on topical subjects concerning GMP and regulatory compliance.

All of the tasks are taken on by members, partners and the Advisory Board.

NEW – With regard to the ECA’s goal to support the industry and authorities in promoting a harmonisation of GMP and regulations in Europe, the Academy initiated the European Qualified Person Association. QPs from all over Europe already signed up for a membership. You’ll find more information on this new group and its goals in our news from 10 August and on the association’s website at www.qp-association.eu.

 
     
 

ECA's Tools

  
     
 
  • The development of the GMP Guideline Manager Software
  • Providing an Internet platform (www.gmp-compliance.org) for research on and interpretation of the regulations
  • The development of GMP tools (e.g. GMP Matrix)
  • The organisation of education courses and conferences on topical subjects concerning GMP and regulatory compliance.
  
     
 

Chairman of ECA

  
     
 

In order to do justice to the quickly-growing number of members, on 15 July 2001 Dr Peter Reichelt, Managing Director of Reichelt Chemietechnik, was appointed Chairman of the European Compliance Academy. Starting from October 2005, Daniel Scheidegger, Vice President Operations and Managing Director of Genzyme Pharmaceuticals Liestal, has been appointed as the new ECA Chairman. The ECA Chairman is elected by the Advisory Board for a period of 2 years. After this period, a new Chairman can be named, or the same Chairman can be re-elected.

  
     
 

ECA Advisory Board

  
     
  The ECA Advisory Board represents European regulatory authorities as well as the pharmaceutical and biopharmaceutical industry. By their voluntary work, the board members support ECA in fulfilling its mission to impart most relevant knowledge on the interpretation and implementation of GMP and regulatory requirements.  
     
Daniel Scheidegger Daniel Scheidegger
Genzyme Pharmaceuticals, Switzerland
Chairman
Field of expertise: FDA Compliance
Matt Moran Matt Moran
PharmaChemical, Ireland
Active Pharmaceutical Ingredients		 Dr W. Schumacher Dr W. Schumacher
F. Hoffmann-La Roche, Switzerland
Computer Validation (incl. Part 11)
Rudolf Völler Rudolf Völler
Regierungspräsidium Darmstadt, Germany
GMP Supervision		 John Taylor John Taylor
MHRA, UK
GMP Supervision
Dr Ludwig Huber Dr Ludwig Huber
Agilent Technologies, Germany
Analytical Quality Control		 Dr Bernd Renger Dr Bernd Renger
Vetter Pharma-Fertigung GmbH & Co. KG, Germany
Analytical Quality Control
Dr Boris Pimentel Dr Boris Pimentel
DNP (DSM-Nutritional Products), Switzerland
Regulatory Affairs		 Colin Booth Colin Booth
Oxoid Limited, UK
Development Microbiology
Richard BonnerRichard Bonner
Associate Partner CONCEPT HEIDELBERG, UK
Quality Assurance		  
     
The team focuses on the development of new courses and conferences on emerging GMP challenges. The evaluation of all events by the Advisory Board ensures best quality and participant satisfaction.
     
 

ECA Membership Opportunities

  
     
 

So far it was only possible to become an ECA member through attending one of the ECA courses or conferences. From 2007 on this will change.

In addition to automatically becoming a member by participating in one of the European Compliance Academy courses or conferences marked with ECA (exception: Webinars) the Academy will offer two membership opportunities - an individual membership and a company membership.

Both will offer a whole range of benefits without requiring the attendance of a course or conference. To get more information, please read here. To apply for membership, please fill in the application form.

  
     
 

If you have any further questions regarding our organisation, please contact us.
European Compliance Academy
P.O. Box 10 21 68, 69011 Heidelberg, Germany

  

 

Become an ECA Speaker!

 
     
  Many experts from European and US authorities as well as from the industry already joined the team of ECA speakers and give regular lectures during our courses and conferences. To learn more about the benefits and how you qualify, please click here.

 

  
 

History and Annual Review

 
   
 

01/01/1999

 

Foundation of ECA by 7 private persons

Elaboration and finalisation of statutes which require ECA not to pursue financial aims. The following objectives are adopted:

  • Annual update of a CD-ROM which makes it possible to search quickly and easily the pharmaceutical regulations of international relevance, above all those on GMP

  • Organisation of high-quality GMP courses and conferences with reduced registration fees for ECA members and for representatives from European regulatory or supervisory authorities

  • Creation and updates of a web portal on GMP compliance topics. In the beginning, its services are meant to be free of charge also for non-members

02/1999

 

Two specialists are appointed to form the Advisory Board:
Rudolf Völler, Regierungspräsidium Darmstadt, Germany
Dr Wolfgang Schumacher, F. Hoffmann-La Roche, Switzerland

03/1999

 

The free-of-charge web portal www.gmp-compliance.com goes on-line.

21-22/04/1999

 

The first ECA event with the title 'Validation of Analytical Test Procedures' is organised.

07/1999

 

Version 1.0 of the GMP Navigator guideline CD-ROM is released.

31/12/1999

 

The first annual review is published.

The number of members has increased from 7 to 569.

The members come from 26 countries.

During the first year 12 events have been organised.

03/2000

 

Version 2.0 of the GMP Navigator guideline CD-ROM is released.

31/12/2000

 

The second annual review is published.

The number of members has increased from 569 to 1550.

The members come from 31 countries.

During the second year 20 events have been organised.

04/2001

 

Version 3.0 of the GMP Navigator guideline CD-ROM is released.

30/06/2001

 

Extension of the Advisory Board to 11 members.

Development of the Professional Certification Programme (today GMP Certification Programme).

15/07/2001

 

Dr Peter Reichelt, Managing Director of Reichelt Chemietechnik, appointed ECA Chairman.

03/2002

 

Version 4.0 of the GMP Navigator guideline CD-ROM is released.

12/2002

 

The number of members increases to 2,539 people from 39 countries.

02/2003

 

Version 5.0 of the GMP Navigator guideline CD-ROM is released.

05/2003

 

New Web service "Guideline Tree" is available for ECA Members.

02/2004

 

Version 6.0 of the GMP Navigator guideline CD-ROM is released.

23/08/2004

 

Extension of the Advisory Board to 12 members.

02/2005

 

Version 7.0 of the GMP Navigator guideline CD-ROM is released.

08/07/2005

 

ECA holds its first annual Advisory Board Meeting in Heidelberg.

06/10/2005

 

Daniel Scheidegger is appointed as the new ECA Chairman.

Former Chairman Dr Peter Reichelt retires from the ECA Advisory Board.

ECA publishes its new mission.

17/10/2005

ECA publishes first ECA Good Practice Guide.

24/01/2006

Mike Edgington named Director for Regulatory Affairs at ECA.

03/2006

Version 8.0 of the GMP Navigator guideline CD-ROM is released.

06/2006

 

ECA Working Group is founded at the Federal Agency for Sera and Vaccines.

07/2006

 

ECA establishes European Qualified Person Association.

12/2006

 

In addition to individual membership, ECA also offers company membership from 2007 on.
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
 
  

ECA's 1st Annual Review (1999)

ECA's 2nd Annual Review (2000)

ECA's 3rd Annual Review (2001)

ECA's 4th Annual Review (2002)

ECA's 5th Annual Review (2003)

ECA's 6th Annual Review (2004)

ECA's 7th Annual Review (2005)

ECA's 8th Annual Review (2006)

ECA's 9th Annual Review (2007)