By Shrinivas (Cheenu) Murti

Published in: CFPA Course

Published on: October 9, 2019

Course Description: This advanced, highly interactive course will take CMC submission training to the next level. This one-day workshop will allow participants to simulate steps involved in the creation of the CMC section (CTD Modules 2.3 and 3) of global marketing applications in a hands-on setting through guided role-playing and analysis of outcomes. The simulation will cover technical data collation, application of relevant regulatory guidelines, creation of a cohesive submission, and strategies during agency review. Case studies pertinent to NDAs/ANDAs/BLAs, MAAs and JNDAs will be used and include drug substance and oral and parenteral dosage forms. The simulation will conclude with an interactive discussion of the case studies in terms of best practices for critical thinking and informed decision-making to increase the chances of regulatory success.

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