Center for Professional Innovation & Education, Inc., King of Prussia, PA
Oct. 3 & 4, 2013
This course focuses on the regulatory and procedural requirements required for Pharmaceuticals, Medical Devices, Biologics and Combination products in Japan. The two-day program will cover topics relating to CMC, pre-clinical and clinical requirements, as well as, addressing the structure of regulatory agencies in Japan. Also included will be detailed descriptions of the methods by which regulators within various agencies process filings and registrations and what is expected in the authorization and dossier maintenance of all licensed products. The course will also discuss strategies to bridge development work done in other regions into the Japanese market. These bridging strategies are also valuable in helping to increase the value of products prior to licensing with Japanese Pharmaceutical and Biotechnology companies.
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