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#6: Control Strategy for Drug Substance Based on ICH M7 and Q11

Nov 6 2013 11:00AM - Nov 6 2013 12:45PM | TFT Halls & Rooms TFT Building, 3-6-11 Ariake, Koto-ku, Tokyo 135-8071 Japan

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Session Chair
Haruhiro Okuda, PhD
Deputy Director General, National Institute of Health Sciences

DNA reactive (mutagenic) impurities that have a potential to directly cause DNA damage has been discussed as ICH M7 and released for public comment. Current ICH quality guidelines apply to the marketed products, however, ICH M7 covers both of marketed products and investigational products during clinical development. In addition, ICH Q11 provides further clarification on the principles and concepts described in Q8, Q9 and Q10 as they pertain to the development and manufacture of drug substance. Risk management and scientific knowledge are used more extensively and develop appropriate control strategy applicable over the lifecycle of the drug substance. This session provides overview of ICH M7 for further understanding and control strategy of drug substance based on ICH M7 and Q11.

Overview of ICH M7 (Step 2)
Yukio Aso, PhD
Section Chief, National Institute of Health Sciences

ICH M7/Q11, Expectations and Status; Including MHLW
Sponsored Science Research Study
Kazunori Takagi, PhD
Principal Reviewer,
Pharmaceuticals and Medical Devices Agency (PMDA)

Contact Information 

DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200


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