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CMC Strategy Forum Japan 2019
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 Thank you to all that participated and helped make CMC Japan 2019 a success! We look forward to seeing you next year:
7-8 December 2020 in Tokyo, Japan!

On behalf of the CASSS Board of Directors and the CMC Strategy Forum Global Steering Committee, I would like to extend to you a warm welcome to the eighth meeting of the CMC Strategy Forum Japan 2019 that will be held 11-12 December in Tokyo, Japan.  

We are very pleased that with the strong support from the Pharmaceuticals and Medical Devices Agency (PMDA, Japan), as well as the Japan Pharmaceutical Manufacturers Association (JPMA), and with the continued organization by CASSS and the support from the United States Food and Drug Administration, that we are continuing with the CMC Strategy Forum Japan 2019. Our 2018 Forum continued to be a great success and included participation from nine regulatory agencies, twelve countries and 48 companies and academic institutions, enabling an in-depth discussion of global CMC issues with special emphasis on Japan and Asia-Pacific. The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Japan and Asia and will feature an opening regulatory session that will include presentations from PMDA, US FDA, EMA and Health Canada. In addition, there will be an ASEAN regulatory updates session; the following regulatory agencies have been invited to participate: ASEAN; National Agency of Drug and Food Control, Indonesia; Ministry of Food and Drug Safety (MFDS), Republic of Korea; National Pharmaceutical Regulatory Agency (NPRA), Malaysia; Ministry of Public Health, FDA Thailand; and Drug Administration of Vietnam. The technical sessions will include discussions on advanced-type antibody products (bispecific, drug conjugate) and technologies related to viral validation and an update about the ICH Q5A revision. 

With this exciting program, I would like to extend to you an invitation to attend and participate actively in making this Forum a great success.

Wassim Nashabeh
On behalf of the CMC Strategy Forum Global Steering Committee 


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CMC Strategy Forum Japan is supported by the Pharmaceuticals and Medical Devices Agency, Japan
and the Japan Pharmaceutical Manufacturers Association


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