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ICH Q8/Q9/Q10 and Other Quality Guidelines
- ICH Training
- Training
APEC LSIF / JCCT workshop, December 3-5, 2008, Beijing, China
In December 2008, a 3-day workshop on the Implementation of ICH Q8/Q9/Q10 and Other Quality Guidelines was organised in Beijing, China. The ICH Quality by Design workshop was held under the auspices of the US Department of Commerce, Chinese State Food and Drug Administration (SFDA), Joint Committee for Commerce and Trade (JCCT), International Conference on Harmonisation (ICH), APEC Life Sciences Innovation Forum (LSIF) and supported by the China Center for Pharmaceutical International Exchange (CCPIE).
The Workshop was attended by over two hundred participants, representatives from the Chinese SFDA, Center for Drug Evaluation (CDE), the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) in China, representatives of local pharmaceutical companies, representatives of multinational companies, and representatives from US FDA offices established in China.
Speakers included a number of ICH experts from EU, EFPIA, MHLW, PMDA, FDA, PhRMA and Health Canada.
Workshop
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Day 1
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Evolution of ICH: Shift from Input to Output - The Influence of the CTD
Dr. Justina Molzon, Food and Drug Administration (FDA), USA
The Quality Guidelines - An Overview
Dr. Susanne Keitel, European Directorate for the Quality of Medicines and Healthcare (EDQM - Council of Europe)
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A Regulatory Perspective - Japan
Dr. Yoshihiro Matsuda, Ministry of Health, Labour & Welfare (MHLW), Japan
A Regulatory Perspective - Canada
Dr. Krishnan Tirunellai, Health Canada
An Industry Perspective
Dr. Ling Ye, Hospira, USA
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Why Q8/9/10? How they are different from Q1-Q7?
Dr. Robert Baum, Pfizer, USA
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A Regulatory Perspective
Dr. Moheb Nasr, Food and Drug Administration (FDA), USA
An Industry Perspective
Dr. Brian Withers, Abbott, UK
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Overview
Dr. Brian Withers, Abbott, UK
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Day 2
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A Regulatory Perspective
Mr. Joseph Famulare, Food and Drug Administration (FDA), USA
An Industry Perspective
Dr. Graham Cook, Wyeth Pharmaceuticals, UK
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A GMP Inspector's Perspective
Dr. Ian Thrussel, Medicines and Healthcare Products Regulatory Agency (MHRA), UK
An Industry Perspective
Dr. Tobias Massa, Bristol-Myers Squibb, USA
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Control Strategy Case Studies
Dr. Vance Novack, GlaxoSmithKline, UK and Dr. Brian Johnson, Merck, USA
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ICH Q8/9/10 Implementation Working Group
Mr. Jacques Morénas, Agence française de sécurité sanitaire des produits de santé (AFSSAPS), France
Challenges and Opportunities in Implementing Q8, Q9 and Q10
Mr. Jacques Morénas, Agence française de sécurité sanitaire des produits de santé (AFSSAPS), France
Implementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan
Dr. Yukio Hiyama, Ministry of Health, Labour and Walfare (MHLW), Japan
An Opportunity to Build Quality Into Product
Dr. Krishnan Tirunellai, Health Canada
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Day 3
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Progressive Licensing and the Modernization of the Canadian Regulatory Framework
Mr. Mike Ward, Health Canada
US FDA's Question-based Review for Generic Drugs
Dr. Lawrence Yu, Food and Drug Administration (FDA), USA
The Impact of Excipient Variability on QbD; IPEC America's Perspectiive
Mr. David Schoneker, International Pharmaceutical Excipients Council
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