ICH Quality Guidelines
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APEC LSIF workshop, September 12-14, 2007, Seoul, Korea
In September 2007, a workshop on ICH Quality Guidelines was held in Seoul, Korea, under the theme of "Opportunities and Challenges Related to Implementation." This APEC Life Sciences Innovation Forum-supported workshop was held in response to requests from regulators in APEC economies on how to achieve the economic production of quality pharmaceuticals and thus contribute to the safety, efficacy and affordability of therapeutic products.
The two-day workshop was attended by regulators, policy makers, academia and industry from interested APEC economies and involved participation from a number of ICH experts.
The programme objectives included a practical explanation of ICH guidelines and an interactive discussion of the anticipated challenges and opportunities associated with the implementation of Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System) in APEC regions.
Workshop
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Day 1
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Role of ICH Quality Guidance Documents In Advancing Life Sciences in the APEC RegionMr. Mike Ward, Health Canada
Current KGMP and PerspectiveDr. Dong Sup Kim, Korea Food and Drug Administration (KFDA)
Linking ICH Quality Guidelines to GMPProf. Anthony Webber, Queensland Clinical Trials network, Australia
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A Regulatory Perspective
Dr. Suzanne Keitel, Federal Institute for Drugs and Medical Devices, Germany
An Industry PerspectiveDr. Paul Stott, AstraZeneca, USA
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A Regulatory Perspective
Mr. Jacques Morénas, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
An Industry PerspectiveDr. Thomas Schultz, Johnson & Johnson, USA
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Day 2
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A Regulatory Perspective
Dr. Yukio Hiyama, Ministry of Health, Labour and Welfare (MHLW), Japan
A Regulatory PerspectiveDr. Ian Thrussel, Medicine Control Agency, UK
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A Regulatory Perspective
Dr. Blair Fraser, Food and Drug Administration (FDA), USA
An Industry PerspectiveDr. Elaine Esber, Merck, USA
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Opportunities and Challenges related to Implementation
Mr. Mike Ward, Health Canada
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The ICH Secretariat fully acknowledges the Korea Health Industry Development Institute for providing these slides, presented at the APEC ICH Quality Guidelines workshop on "Opportunities and Challenges Related to Implementation", in September 2007, in Seoul, Korea.