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Workshop on Review of Drug Development in Clinical Trials
- ICH Training
- Training
APEC LSIF/ Thai FDA workshop, 2-6 February 2009, Bangkok, Thailand
In February 2009, a 5-day advanced workshop on the Review of Drug Development in Clinical Trials was held in Bangkok, Thailand. The workshop which was hosted by the Thai FDA, and supported by the APEC Life Sciences Innovation Forum, was attended by over twenty Drug Regulators from ten countries both from Asia and beyond. Speakers included experts from PMDA, Health Canada and Novartis.
This advanced workshop was in continuation of the preliminary workshop that was held in March 2008. A second series of training events held in Thailand includes two 3-4 days workshops (preliminary & advanced) on GCP Inspection.
Workshop
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Day 1
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Opening and Welcome Speech
Mrs. Werawan Tangkeo, Thai Food and Drug Administration (FDA), Thailand
Information Sharing Session - Follow-up from the Preliminary Workshop
Dr. Norman Viner, Health Canada
Update in PMDA
Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
'Refresher' of preliminary course topics
Dr. Norman Viner and Dr. Will Stevens, Health Canada
What is required for setting up the business of a review operation?
Dr. Norman Viner and Dr. Will Stevens, Health Canada
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Day 2
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Session on Chemistry and Manufacturing (Quality) review let by Dr. Will Stevens, Health Canada.
This session covers and contrasts requirement for chemical entity drugs and biologics, including traditional biologics such as blood and components, hormones extracted from urine, and recombinant products.
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Day 3
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Review Principles of Dose Selection
Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Approach to the Critique of High Risk Trials - Practical Interpretations and Application of Guidances, a Regulatory Perspective
Dr. Norman Viner, Health Canada
Development to 1st in Man
An Industry Perspective, Dr. Sudhichai Chokekijchai, Novartis, Thailand
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Day 4
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Adaptive Seamless Design
Dr. Sudhichai Chokekijchai, Novartis, Thailand
Ethics in Clinical Trials
Dr. Norman Viner, Health Canada
Science Based Approach: Review of Drug Development Article and Recent Example
Dr. Norman Viner, Health Canada
Pharmacovigilance: a Regulatory Perspective
Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Risk Management Plans: an Industry Perspective
Dr. Sudhichai Chokekijchai, Novartis, Thailand
Pharmacovigilance Challenges
Dr. Norman Viner, Health Canada
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Day 5
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Clinical Trial Review Practicum (small group exercises)
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