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Pharmacology / Health / Clinical research / Quality / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use / Regulatory requirement / Quality by Design / Food and Drug Administration / Good manufacturing practice / Pharmaceutical sciences / Pharmaceuticals policy / Pharmaceutical industry


Recommended Speakers on ICH Q8, Q9, and Q19 for JCCT QbD Workshop
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Document Date: 2012-06-22 04:03:18


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City

Beijing / Other Risk / /

Company

Hospira / ICH Guidelines / Matsuda / PIC/S / Pfizer / GlaxoSmithKline / Merck / Health Canada / Agency for the Safety / ICH Global Cooperation Group / Bristol-Myers Squibb / /

Continent

America / /

Country

France / Japan / United States / Canada / United Kingdom / China / /

Facility

National Institute of Health Sciences / /

IndustryTerm

pharmaceutical development / manufacturing activities / non-prescription products / pharmaceutical industry / drug product / quality risk management / pharmaceutical / manufacturing process / pharmaceutical quality system / pharmaceuticals / pharmaceutical quality assessment / health products / product lifecycle management / biologic products / pharmaceutical and manufacturing sciences / manufacturing / pharmaceutical formulations / drug products / pharmaceutical quality / pharmaceutical development studies / /

Organization

International Pharmaceutical Excipients Council / National Institute of Health / Food and Drug Administration / office of Compliance / Bureau of Pharmaceutical Sciences / Department of Drug Registration / US Department of Commerce / office of International Programs / FDA’s office of Generic Drugs / Institute of Health Sciences / European Directorate for the Quality of Medicines and Healthcare / International Programs Division / Department of International Cooperation / International Affairs Department / Agency for the Safety of Health Products / Third Section Division of Drugs / office of New Drug Quality Assessment / China Office / Center for Drug Evaluation and Research / office of Generic Drugs / Medicines and Healthcare products regulatory Agency / Council of Europe / Center for Drug Evaluation / US-China Joint Council on Commerce / Ministry of Health / Asia-Pacific Economic Cooperation / /

Person

Vance Novak / Christopher Hickey / Mike Ward / Jacques Morénas / Yoshihiro Matsuda / Brian Withers / Joe Famulare / Zhang Peipei / Mark Paxton / Robert Baum / Justina Molzon / Krishnan Tirunellai / Ling Ye / Ian Thrussel / Lunch Moderator / Brian Johnson / David Schoneker / Susanne Keitel / Chen Xingyu / Lawrence Yu / Jin Shao Hong / Yukio Hiyama / Tobias Massa / Graham Cook / Zhang Wei / /

Position

Director / International Affairs / Manager / speaker / Director General / Senior Medicines Inspector / Deputy Director General / Chairman / Professor / Deputy Director / Director / Senior Scientific Advisor / Manager International Programs Division / Chief / /

Product

Q8 / Q8/Q9 / /

Technology

Quality of Service / drug development / /

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