2024年医药行业日本CMC战略论坛(CMC Strategy Forum Japan)嘉宾演讲PPT合集（共12套打包）

1、Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.Regulatory Updates and a Perspective on Biopharmaceuticals in JapanSAKURAI Akira,Ph.D.Senior Scientist for Biopharmaceutical Q。

2、1Pharmaceuticals and Medical Devices AgencyDisclaimer:The contents of this presentation represent the view of this presenter only,and do not represent the views and/or policies of the PMDA.Quality Co。

3、International Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human UseCell&Gene Therapy Discussion Group(CGT DG):Progress toward Delivering a Strategic RoadmapCASSS CM。

4、1LLwww.fda.govICH Efforts towards Developing a Unified ICH Q6(R1)and Modernizing Global Standards for Specifications Setting Ingrid Markovic,Ph.D.Senior Science Advisor for CMCFDA/CBERRegulatory Chai。

5、2024 CMC Strategy Forum JapanTokyo Marriott Hotel,JapanDecember 9-10,2024Update on the initiatives at the Center for Biologics Evaluation and Research(CBER),U.S.FDAIngrid Markovic,Ph.D.Senior Science。

6、Challenges in the Clinical Implementation of piggyBac Transposon mediated CAR-T cell TherapyShigeki Yagyu A-SEEDS Co.,Ltd.Shinshu University Innovative Research&Liaison OrganizationCMC Strategy F。

7、Copyright Pharmaceuticals and Medical Devices Agency,All Rights Reserved.CMC Strategy Forum Japan 2024,9-10 December,2024,Tokyo Marriot Hotel,Tokyo,JapanKISHIOKA Yasuhiro,Ph.D.Review DirectorOffice o。

8、ICH Q6 Revision towards globally harmonized specificationsTakahiro YamaguchiAsahi Kasei Pharma Corporation10 December 2024CMC strategy forum Japan 2024Disclaimer:The views and opinions expressed here。

9、中国食品药品检定研究院National Institutes for Food and Drug ControlEstablishment of Specifications for Monoclonal AntibodiesChuanfei Yu PhDNational Institutes for Food and Drug ControlDisclaimerDisclaimer:This 。

10、Role of ICH Q2/Q14 and ICH Q6 on establishment of control strategy CMC Strategy Forum Japan 2024Dec 10thHiroko Shibata,PhD.Division of Biological Chemistry and Biologicals,National Institute of Healt。

11、ICMRA efforts to achieve Regulatory Convergence and Reliance A Progress Report on the Collaborative Assessment and Hybrid Inspection PilotsStelios Tsinontides,Ph.D.,FAIChEDirectorOffice of Pharmaceut。

12、ICH GL Update:M4Q(R2)Expectations from an Industry Point of ViewHiroshi Ohtsuka(JPMA,Bayer Yakuhin Ltd.)1The views and opinions expressed in this presentation are those of the presenter and should no。