The VirtualPharm
Duración total:
6 h 36 min
Ten CMC Questions for Emerging Biotechs in 2025
The VirtualPharm
23:05
CMC Regulatory for Early Drug Development Success
The VirtualPharm
21:15
Setting Drug Specifications in Data-Limited Scenarios
The VirtualPharm
20:44
Mastering CMC Quality Module 3 & QOS for NDA Submissions
The VirtualPharm
20:03
Playing Monopoly in Real Life – The Game of Regulatory CMC in Drug Development
The VirtualPharm
15:25
The Role of API Process Development in CMC Drug Development
The VirtualPharm
15:37
Enhancing CMC Efficiency with Augmented Intelligence for Biotechs
The VirtualPharm
14:23
Mastering Stability Studies: The Blueprint for Drug Substance & Product Success
The VirtualPharm
27:50
A Comprehensive CMC Strategy Document – Quick Guide
The VirtualPharm
18:20
Rules for Writing the Common Technical Document Quality Module 3
The VirtualPharm
17:53
2024 ICH Guideline Reveals: Essential CMC and Drug Development Insights
The VirtualPharm
26:31
Integrating Knowledge into Risk-Based Decision-Making with ICH Q9(R1)
The VirtualPharm
29:55
Mastering the Art of Authoring a CMC Quality Module 3 and QOS for an NDA: A Simple Guide
The VirtualPharm
11:53
6 Haunting Regulatory CMC Challenges on Halloween (and How to Survive Them!)
The VirtualPharm
18:17
Robust Stability Protocol for CMC Submissions
The VirtualPharm
02:30
Strategic Timing for Defining Regulatory Starting Materials (RSMs)
The VirtualPharm
03:33
What Does CMC Regulatory Affairs Do?
The VirtualPharm
18:23
Strategic Outsourcing: A New Era in Drug Development
The VirtualPharm
07:57
Developing a Regulatory CMC Strategy for Global Markets, with an Emphasis on ICH Guidance
The VirtualPharm
20:35
Mastering Process Design: Your Roadmap to Success in Drug Development
The VirtualPharm
11:14
Critical Components of a Robust CMC Due Diligence Framework (with a Focus on Drug Substance)
The VirtualPharm
14:28
Building a Robust NDA/BLA Strategy: Ethan and Desi Discuss 5 Strategic Steps in Regulatory CMC for Approval
The VirtualPharm
16:15
A Strategic Guide to Timely Drug Approval Focused on the Quality Modules: Ethan and Desi Discuss Drug Approval
The VirtualPharm
10:18
Bringing Regulatory CMC to Life
The VirtualPharm
10:22
