The Parenteral Drug Association (PDA) has announced that the third Joint European Medicines Agency (EMEA) and PDA Conference will be held on 13-14 October 2009 in Berlin, Germany.
The inspection/good manufacturing practice (GMP) event is said to provide an opportunity for those that need updates on current thinking and guidance in these areas.
With 33 key speakers from EMEA and a variety of authorities across Europe, each presentation will cover legislation, guidance and GMP initiatives under the conference's theme of 'Ensuring Patient Safety through Supply Chain Control and GMP'.
There will be three parallel tracks of the conference, which will address different areas.
'Supply Chain Quality' will cover the proposed European Commission Pharmaceutical Package; how inspections of importers are handled by a major inspectorate; and the most common inspection findings and areas for improvement.
'Implementation of ICH Q8-9-10' will address the characteristics of recent successful filing or variation; industry and regulator perspectives and examples of an experimental design to support quality by design; and how inspectors are trained.
'High-Interest Issues in Manufacturing and GMP' will focus on the latest guidance and interpretation of GMP requirements for investigative medicinal products (IMP); common inspection observations and issues; industry perspectives on current issues surrounding IMP production; and the impact of the US Food and Drug Administration's draft guideline on process validation in Europe.
During the event, there will also be extra time for discussions of key issues, focus on 'real-life' and practical experiences, and networking with speakers and like-minded colleagues.
