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CMC Strategy Forum Japan 2017
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Thank you to all who participated and helped make CMC Strategy Forum Japan a success! We look forward to seeing you 3-4 December 2018 at the Tokyo Marriott Hotel 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 fifth meeting of the CMC Strategy Forum Japan 2017 that will be held 4-5 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 2017. Our 2016 Forum continued to be a great success and included participation from seven 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, FDA, EMA and Health Canada. Other regulatory agencies that have been invited include ASEAN, China Food and Drug Administration and Ministry of Food and Drug Safety, Korea. The technical sessions will include discussions on: post-approval change control and Japan Approval Form System; challenges in global development of drug device combination products; and use of prior knowledge to support CMC development in conventional and expedited settings.

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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