Retrospect of the Past GMP Conferences


About the 8th European GMP Conference

The ECA´s  8th European GMP Conference’s delegates, speakers from the industry and GMP inspectors from Denmark, Germany and Finland focused once again on “GMP meets Inspectorates” – with four sessions concentrating on current initiatives in the EU and from the FDA. Especially the MRA procedure between the EU and the US was a topic extensively discussed. Further, the new and revised ECA Good Practice Guides introduced and presented during the conference generated great interest, just like the session on Urgent GMP Non-Compliance Issues. The attention in the tutorial workshops was on new developments in GDP, Data Integrity and Validation/Qualification.


About the 7th European GMP Conference

ECA´s 7th European GMP Conference had the slogan GMP meets Inspectorates and was divided into 5 sessions with focus to current initiatives in EU and FDA, Data Integrity of GMP Data, Quality Oversight and statistical /reduced Sampling. In session 5 delegates discussed current and future developments in ECA´s GDP, Validation and Quality Control working groups towards harmonisation. There were speakers from FDA, EMA, from national inspectorates (MHRA, german inspectorates) and high level industry Speakers.


About the 6th European GMP Conference

ECA´s 6th European GMP Conference was divided into 5 sessions regarding current initiatives in EU and FDA, Trending of GMP Data, building a bridge from GMP to GDP and new EU and FDA validation requirements. In session 5 delegates discussed current and future developments in ECA´s working and interest groups towards harmonisation.   


About the 5h European GMP Conference

The ECA has dedicated the fifth biennial European GMP Conference to recognise the 50th anniversary of the first published GMP regulations and further the work towards a harmonized set of GMP regulations for medicinal Products. In Addition, the conference included parallel sessions for interest group meetings that allowed concrete discussions about how we could promote a harmonization set of GMP regulations. High level speakers included:

  • Klaus Eichmüller, District Government of Upper Bavaria Munich, GMP Inspectorate, Germany
  • Dr Matthias Heuermann, Matthias is a European GMP Inspector at the NRW Center for Health (LZG.NRW)
  • Ian Holloway, Medicines & Healthcare Products Regulatory Agency (MHRA), U.K., Chairmen of ECA Working Groups


About the 4th European GMP Conference

The forth biennial European GMP Conference was focussed on GMP harmonisation. Five parallel sessions under the motto „Authority meets Indus­try - Industry meets Authority” contributed to the concrete discussion and showed solu­tion approaches. High level speakers included:

  • Bernd Bödecker, Trade & Industry Inspection Agency of Lower Saxony, Germany
  • Grace McNally, FDA, USA
  • Dr Janice Soreth, FDA, USA
  • Grace Yi-Ni Ye, SFDA, China
  • Ian Thrussel MHRA,
  • Lionel Viornéry, AFSSAPS, France
  • Julie Maréchal-Jamil, EGA, Belgium


About the 3rd European GMP Conference

GMP initiatives to meet globalisation were covered in detail at the 3rd European GMP Conference in 2009. Therefore, sessions with the slogan “authority meets industry” were hold. High level speakers included:

  • Thomas Arista , FDA, USA
  • Hélène Bruguera, EDQM
  • Dr Jean-Denis Mallet, International Committee Red Cross Pharmaceutics
  • Benoîte Rime, USP


About the 2nd European GMP Conference

The international GMP harmonisation was covered in detail at the 2nd European GMP Conference in 2007. High level speakers included:

  • Frederick Blumenschein, FDA, USA
  • David Cockburn, EMEA, UK
  • Dr Susanne Keitel, BfArM, Germany
  • Dr Jacques Morénas, AFSSAPS, France
  • Dr Dirk Barends, RIVM, The Netherlands
  • Dr Jürgen Mählitz, District Government of Upper Bavaria, Germany Dr Sabine Paris, ZLG, Germany
  • John Taylor, MHRA, UK
  • Rudolf Völler, Regional Council Darmstadt, Germany


About the 1st European GMP Conference

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. Speakers were among others:

From authorities:

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


From ICH Q 8 and Q 9 working Groups:

  • 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