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Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences

Controlled Correspondence on Clinical Pharmacology Topics in Generic Drug Development

Course Feedback 

Course Resources: Download Agenda (Modeling and AI in Generic Drug Development 2025)

Cross-Comparison to Other Drug Master Files and Lessons Learned  

Customer Perspective: Initial Evaluation of an Outsourcing Facility (FDA Compounding Conference 2025)

Customer Perspective: Ongoing Evaluation of an Outsourcing Facility

Day 1, Session 1 Q&A (Clinical Investigator Training Course 2024)

Day 1, Session 1 Q&A (Generic Drugs Forum 2025)

Day 1, Session 2 Q&A

Day 1, Session 2 Q&A (Clinical Investigator Training Course 2024)

Day 1, Session 2 Q&A (Generic Drugs Forum 2025)

Day 1, Session 3 Q&A (Generic Drugs Forum 2025)

Day 1, Session 4 Q&A (Generic Drugs Forum 2025)

Day 2, Session 1 Q&A (Clinical Investigator Training Course 2024)

Day 2, Session 1 Q&A (Generic Drugs Forum 2025)

Day 2, Session 2 Q&A (Clinical Investigator Training Course 2024)

Day 2, Session 2 Q&A (Generic Drugs Forum 2025)

Day 2, Session 3 Q&A (Clinical Investigator Training Course 2024)

Day 2, Session 3 Q&A (Generic Drugs Forum 2025)

Day 2, Session 4 Q&A (Generic Drugs Forum 2025)

Day 3, Session 1 Q&A (Clinical Investigator Training Course 2024)

Day 3, Session 2 Q&A & Closing Remarks (Clinical Investigator Training Course 2024)

Day One Closing Remarks (Advancing Generic Drug Development 2024)

Day One Q&A Session with Panel (Particle Size Analysis)

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