Review of Drug Development in Clinical Trials
- Training Archive
- Training
APEC LSIF / Thai FDA workshop, March 17-21, 2008, Bangkok, Thailand
In March 2008, a 5-day preliminary workshop on the Review of Drug Development in Clinical Trials was held in Bangkok, Thailand. This preliminaryworkshop which was hosted by the Thai FDA, and supported by the APEC Life Sciences Innovation Forum was attended by over twenty Drug Regulators from eight countries both from Asia and beyond. Speakers included a number of ICH experts from PMDA, PhRMA and Health Canada.
The workshop is part of a series of two training events. The first series includes two 5-day workshops (preliminary & advanced) on the Review of Drug Development in Clinical Trials, and the second series includes two 3-4 days workshops (preliminary & advanced) on GCP Inspection. The advanced workshop on the Review of Drug Development in Clinical Trials was held in February 2009.
Workshop
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Day 1
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Overview of ICH and the Global Cooperation GroupDr. Odette Morin, ICH Secretariat, Switzerland
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Overview of Regulation of Clinical Trials in Canada
Dr. Celia Lourenco, Health Canada
PMDA and Applications ProceduresDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Clinical Trial Environment: United States (FDA) and European Union (EMA)Ms. Susan D'Amico, Novartis, USA
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Origin of Clinical Trial Regulations: Canadian Perspective
Dr. Celia Lourenco, Health Canada
Roles and Responsibilities in Conduct and Assessment of Clinical TrialsDr. Celia Lourenco, Health Canada
Good Regulatory Practices: Canadian experienceDr. Celia Lourenco, Health Canada
Good Regulatory Practices: Japanese experienceDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Regulations and Guidelines: CMC and Non-ClinicalDr. Celia Lourenco, Health Canada
Regulations and Guidelines: Clinical and PostmarketingDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Inspection (GCP, GMP)Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Clinical Development Plans, Phases, Postmarket Assessment: An Industry Perspective
Dr. Namrata Bahadur, Novartis Pharma AG, Switzerland
Clinical Development Plans, Phases, Postmarket Assessment: A Regulatory PerspectiveDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Clinical Development Plans, Phases, Postmarket Assessment: A Regulator Perspective)Dr. Celia Lourenco, Health Canada
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Objectives of Clinical Trial Assessment
Dr. Celia Lourenco, Health Canada
Concept of Benefit/Risk and How this Changes over Progressive PhasesDr. Celia Lourenco, Health Canada
Qualification Expertise in CanadaDr. Celia Lourenco, Health Canada
Qualification Expertise in JapanDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Day 2
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Manufacture and Import/GMP Requirements/Quality Assessment/Exercises
Dr. Celia Lourenco, Health Canada
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A Regulators Perspective
Dr. Celia Lourenco, Health Canada
An Industry PerspectiveDr. Namrata Bahadur, Novartis Pharma AG, Switzerland
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Day 3
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A Regulator Perspective
Dr. Celia Lourenco, Health Canada
A Regulator PerspectiveDr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Overview with Exercices
Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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Day 4
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ICH E6 Protocol
Ms. Susan D'Amico, Novartis Pharmaceuticals Corporation, USA
Patient Protection, Informed ConsentMs. Susan D'Amico, Novartis Pharmaceuticals Corporation, USA
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Day 5
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Concept of Product Life-Cycle, DSURs and Safety Monitoring Boards
Dr. Junko Sato, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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An Industry Perspective
Ms. Susan D'Amico, Novartis Pharmaceuticals Corporation, USA
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Regulations
Dr. Celia Lourenco, Health Canada
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Canadian Experience
Dr. Celia Lourenco, Health Canada
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