- Welcome
- Drug Development Overview
- FDA History and Organizational Structure
- The Regulatory Affairs Professional in the Biopharma Industry
- Lecture 5: Section 1 Summary
Online
₹ 2,299
Quick facts
particular | details | |
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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
₹ 2,299
certificate availability
Yes
certificate providing authority
Udemy
The syllabus
Section 1: Welcome & Introduction
Section 2: Pre-Investigational New Drug (Pre-IND) - Preclinical Development
- Introduction to the Course Drug
- Basics of Regulatory Intelligence and Developing a Strategy
- Planning Nonclinical Studies with the Investigational New Drug
- Manufacturing Considerations for the Investigational New Drug
- Preparing the IND for FDA Submission
- Section 2 Summary
Section 3: Investigational New Drug (IND) - Clinical Development
- Is It Safe-to-Proceed?
- Clinical Development Strategy: Regulatory Paths & Programs
- IND Management
- Phase 1 & EOP1: Clinical Pharmacology
- Phase 2 & EOP2: Proof-of-Concept and Pediatrics
- Phase 3: Pivotal and Confirmatory Studies
- Section 3 Summary
Section 4: New Drug Application - Getting A Drug Approved
- Preparing the NDA/BLA for FDA Submission
- The NDA/BLA Review Process and Getting FDA Approved
Section 5: Post-Approval - Marketed Drug
- Post-Marketing Maintenance & Label Expansion
Section 6: Course Wrap-Up
- Course Wrap-Up