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CMC Strategy Forum Japan 2016Welcome and Introductory Comments

Takao YamoriExecutive Director / Director of Center for Product Evaluation

Pharmaceuticals and Medical Devices Agency (PMDA)

CMC Strategy Forum Japan 2016, December 5‐6, 2016, Tokyo Marriot Hotel, Tokyo, Japan

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PMDA Updates

Please visit our website!

PMDA Updates

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PMDA Chief Executive Dr. Kondo’s New Year message for 2016

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APEC LSIF RHSC (January 28 to 31)

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The 3rd PMDA Medical Devices Training Seminar (February 15 to 19)

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Launch of "Asian Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs" (April 1)

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DIA 28th Annual Euro Meeting (April 6 to 8)

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Opening ceremony of PMDA Hokuriku Branch (June 9)

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ICH Meeting in Lisbon (June 10 to 16)

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PIC/S Committee Meeting (July 4 to 5)

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Asia‐Pacific Economic Cooperation, Life Science Innovation Forum, Regulatory Harmonization Steering Committee (APEC‐LSIF‐RHSC) Meeting (August 16 to 17)

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The 7th International Meeting of World Pharmacopoeias (September 13 to 14)

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3rd Brazil‐Japan Seminar on Regulations on Pharmaceuticals and Medical Devices (October 4)

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CMC Strategy Forum Japan 2016

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Scientific Program

December 5(09:30‐12:30, 13:45‐15:00)1.  Recent Trends in the Regulation of Biopharmaceutical Products

(15:30 – 18:15)2. Specifications / Potency: Test Procedures and Acceptance Criteria 

for Cell‐based Products

December 6(09:00 – 12:30)3. ICH Q12 Update: Established Conditions in the Manufacturing Process of Biopharmaceuticals

(13:45 – 16:45)4. ICH Q12 Update: Established Conditions in the Specification and Analytical Procedure

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http://www.pmda.go.jp/

Enjoy !