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ICH Q8/Q9/Q10 Guidelines
- ICH Training
- Training
ASEAN workshop, 26-28 July 2010, Kuala Lumpur, Malaysia
In July 2010, a 3-day workshop on the ICH Q8/Q9/Q10 Guidelines was organised in Kuala Lumpur, Malaysia. The ICH Quality workshop was open to both regulators and industries.
The Workshop was attended by over hundred participants.
Speakers included a number of ICH experts from EU and EFPIA, and an expert from the European Pharmacopoeia.
Workshop
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Day 1
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Introduction to ICH
Dr. Jean-Louis Robert, Rapporteur, ICH Quality Implementation Working Group (IWG), National Health Laboratory, Luxembourg
Introduction to ICH Q8: Pharmaceutical Development
Dr. Jean-Louis Robert, Rapporteur, ICH Quality IWG, National Health Laboratory, Luxembourg
Implementation of ICH Q9: Quality Risk Management - Regulatory Perspective
Mr. Jacques Morenas, ICH Quality IWG EU expert, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
Introduction to ICH Q10: Pharmaceutical Quality System
Dr. Georges France, ICH Quality IWG EFPIA expert, Pfizer, UK
ICH Q8/Q9/Q10: Impact and Challenges for the Pharmacopoeias
Dr. Susanne Keitel, European Directorate for the Quality of Medicines and Healthcare (EDQM - Council of Europe), European Pharmacopoeia, France
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Day 2
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Workshop A - Design Space
Lead by Dr. Georges France, ICH Quality IWG EFPIA expert, Pfizer, UK
Workshop B - Control Strategy
Lead by Dr. Jean-Louis Robert, Rapporteur, ICH Quality Implementation Working Group (IWG), National Health Laboratory, Luxembourg
Workshop C - Pharmaceutical Quality System
Mr. Jacques Morenas, ICH Quality IWG EU expert, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
Workshop D - Pharmacopoeial Requirements and the New ICH Quality Paradigm - Time for a Change?
Lead by Dr. Susanne Keitel, European Directorate for the Quality of Medicines and Healthcare (EDQM - Council of Europe), European Pharmacopoeia, France
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Day 3