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- Course Overview
- Course Contents
- Career Opportunities in Regulatory Affairs
- Introduction and Objective of Course
- Common Websites and Usage
- ICH Guidelines
- Literature Survey
- General Quiz
Quick Facts
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Medium of instructions
English
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Mode of learning
Self study
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Mode of Delivery
Video and Text Based
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Course and certificate fees
Fees information
₹ 449 ₹2,799
certificate availability
Yes
certificate providing authority
Udemy
The syllabus
Course Introduction and overview
Drug Master File
- Drug Master File
- Difference between DMFs and Applications
- Submission of DMF
- Drug Master File Quiz
Common Technical Documents
- Module - 1 Administrative (Region Specific)
- Module - 2 (Summary & Overview)
- Module -3 (Quality) Drug Substance
- Module -3 (Quality) Drug product
- Module -3 (Quality) Drug product
- Module -3 (Quality) Drug product
- Stability Study
- Module 4 (Non-Clinical Study)
- Module 5 Clinical Safety reports Part - I
- Module 5 Clinical Safety reports Part - II
- eCTD Structure
- Basic Demonstration of eCTD Software & eValidator
- Quiz for eCTD & CTD Modules
New Drug Approval (NDA) & Abreviated new drug application (ANDA)
- New Drug Application (NDA)
- (New Drug Approval) NDA Part - II
- Abreviated New Drug Application (ANDA)
Congratulations & Thank you
- Congratulations & Thank you
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