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.