Learning objectives
Anyone wishing to have knowledge specifically related to US DMF submissions & review procedures can enroll for this course
Eligibility
B. Pharm / M. Pharm / B. Sc/ M. Sc. / anyone willing to understand the US DMF regulatory submissions
Syllabus
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Section 1: Submission to USFDA
135 minutes
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- Types of DMF, Type II API DMF, DMF Modules, DMF review 105 minutes
- USDMF closure, changes to DMF 30 minutes