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From GlobalCompliancePanel
Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences - Part I and Part II - Webinar By GlobalCompli
...ation and Licensing Review
o Drug Master File (DMF) Use in Japan
o Labeling Requirements
o Package Insert Requirements
* Variations: Changes to Marketed Products
o Types of Variations
o Variation Filings and Typical Review Times
* License Renewals
o Japan's Process; What has recently changed
o License Terms
more...
