The European Compliance Academy (ECA) is delighted to announce that Piotr Krauze has kindly agreed to represent the European Medicines Agency (EMEA) at the ECA 2nd Good Development Practice Conference being held in Berlin, Germany, from 22-24 April 2008.

Part 1 of the Conference (22-23 April) will focus on Pharmaceutical Development & IMP Manufacturing. During the sessions, representatives from authorities as well as specialists from the pharmaceutical industry will share their expert knowledge about important GMP aspects, new approaches like PAT and Quality by Design and technical processes from early development up to scale-up and transfer to routine production.

Krauze will join other global regulatory representatives in talking about current issues and future aspects in pharmaceutical development:

• Bernd Bödecker, GMP Inspectorate Hannover
• Prof Gert Ragnarsson, Swedish Medical Products Agency

Part 2 (Analytical Development and IMP release, 23-24 April) is designed to give you an overview of important analytical aspects in development as well as quality control and quality assurance related points to be considered before release of Investigational Medicinal Products (IMPs). The duties of the Qualified Person and OOS handling in early development phases will be other highlights. Also special analytical aspects in the development of biopharmaceuticals will also be addressed.