Date : 7 June 2012 at 13:30

Location : De Montil, Affligem

Fees : for BRAS Members 150€ - For non members 350€

Programme

13h30 The European Directorate for the Quality of Medicines and Healthcare (EDQM)
• Council of Europe, European Union and EDQM
• The EU regulatory framework in pharmaceuticals and its key players
• The European Pharmacopoeia and EDQM
Dr. Pascale Poukens- Renwart, EDQM

14h00 The European Pharmacopeia
• Role of a pharmacopoeia and place of the European Pharmacopoeia in the European regulatory system.
• How to navigate through the European Pharmacopoeia: Interaction between general and specific monographs and chapters.
• Limits and definition of impurities
• International harmonization.
Prof. Jos Hoogmartens, KUL

15h00 Coffee Break

15h30 Certificate of Suitability to the monographs of the European Pharmacopeia (CEP)
• Scope of the procedure
• How to apply for a new CEP
• Revision of CEPs
• Inspection
Dr. Pascale Poukens- Renwart, EDQM

16h00 An update on Quality:
An overview of the most relevant guidelines and a glance at the future
Dr. Katrien Van Landuyt, FAMHP

17h00 End of the session
Ingrid Theeuwes, BRAS Education group
Kristin Meeussen, BRAS Education Group