The Parenteral Drug Association (PDA) invites delegates to the 3rd Joint European Medicines Agency (EMEA) and PDA Conference. This is the only inspection/good manufacturing practice (GMP) event in Europe with direct support from EMEA and provides a valuable opportunity for those who need to update themselves with current thinking and guidance in these areas. With 33 key speakers from EMEA and a variety of competent 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. Three parallel tracks of the conference will address:
Supply Chain Quality: This session will cover the proposed EC "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: addressing the characteristics of recent successful filing or variation; industry and regulator perspectives and examples of an experimental design to support QbD (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 U.S. FDA's draft guideline on process validation in Europe.
http://www.pda.org/emea2009 About PDA - Connecting People, Science and Regulation®
The Parenteral Drug Association (PDA) is a nonprofit international organization and a leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.