Dear Colleagues,  

The pharmaceutical industry has a strictly regulated environment. The core of the regulations is represented by the GMP rules. These are regularly adapted to the state of the art and knowledge in the EU, in the USA as well as in the rest of the world. The harmonisation efforts via the International Conference on Harmonisation (ICH) begin to bear fruit in the GMP environment.

The ECA intends to support this development with the third biennial European GMP Conference. Apart from regulatory updates on the state of the art and knowledge in the GMP area, five parallel sessions under the motto "Authority meets Industry - Industry meets Authority“ contribute to the concrete discussion and show solution approaches.

With this event, the European Compliance Academy is celebrating its 10th anniversary. To mark this special year, we, the University of Heidelberg and the European Qualified Person Association have invited the major stakeholders.

We wish you a successful and interesting conference.

Yours sincerely,

Daniel Scheidegger
Chairman of the ECA Advisory Board and
Managing Director of Genzyme, Liestal
  

In the US, Asia and Europe, GMP Conferences have established themselves as meeting places for the pharmaceutical industry. Therefore, the University of Heidelberg and ECA organised the first biennial European GMP Conference in June 2005, focusing on harmonisation, ICH Q8 and ICH Q9.

.Speaker at the 1^st European Conference in June 2005 were among others:

• David Horowitz, Office of Compliance, FDA, USA
• Lynne Byers, MHRA, UK
• Christina Graffner, MPA, Sweden
• Hans Smallenbroek, PIC/S, Switzerland

• Dr Fritz Erni, Novartis Pharma, Switzerland
• Dr Susanne Keitel, Federal Institute for Drugs and Medical Devices, Germany
• Dr Stephan Rönninger, Hoffmann-La Roche Ltd, Switzerland
• Dr Jacques Morénas, AFSSAPS, France

Click here to view the brochure of the 1^st European GMP Conference.

About the 2^nd European GMP Conference

The 2^nd European GMP Conference was divided into 2 parts. Part 1 of the conference gave an update on GMP developments and harmonisation efforts. Part 2 was divided into 6 sessions. Industry and authority speakers discussed current GMP topics, like PAT, aseptic processing and validation.

Click here to view the list of speakers and moderators in June 2007.

Click here to view the brochure of the 2^nd European GMP Conference.

About the 3^rd European GMP Conference

The 3^rd European GMP Conference covered important developments in the field of GMP compliance especially with the focus on challenges resulting from the globalisation.