Course Outline

Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1

Opening & Framing

• Why technically strong dossiers still fail
• Difference between compliance thinking and regulatory confidence building
• Interactive opening discussion and participant expectations

The Regulatory Mindset

• What happens after submission: internal assessment workflow
• How assessors review Module 2 and Module 3
• Risk-based review approaches in EMA/FDA/WHO
• The Regulatory Confidence Equation
• Why biologics and vaccines are fundamentally different

Red Flags & Pattern Recognition (60 min)

• Top CMC red flags regulators immediately identify
• Case Study 1: Process Change Before Clinical Phase
• Case Study 2: Vaccine Lot Consistency Drift
• Case Study 3: Stability Overconfidence
• Interactive interpretation of regulatory concerns and likely questions

Session 2

Decision-Making Under Uncertainty

• Benefit-risk assessment under incomplete data
• Organisational maturity signals regulators evaluate
• Cross-functional inconsistencies and regulatory perception
• Emergency and accelerated pathways for vaccines and biologics
• Lessons learned from COVID-era regulatory reviews

Interactive Regulatory Decision Simulation

• Participants act as assessors and regulatory leads
• Review of mini biologics/vaccine dossier scenarios
• Decision simulation: approval, major objection, or request for information
• Group discussion and feedback

Final Wrap-Up & Q&A

• Key lessons and practical takeaways
• How successful regulatory teams build confidence proactively
• Open discussion and audience Q&A

Workshop Positioning
This executive workshop is designed to provide strategic insight into how regulators interpret scientific data, assess risk, and build confidence in biologics and vaccine development programs. The course combines assessor perspective, practical CMC examples, and interactive case discussions.

Dr. Manvi Porwal is a Regulatory Affairs CMC expert specialising in biologics development, pharmaceutical quality, and global regulatory strategy. She has held senior regulatory roles across government, industry, and international organisations, providing a unique perspective on the development and assessment of biological medicines.

Dr. Porwal previously served as a Scientific Assessor at the Paul-Ehrlich-Institut (PEI), where she evaluated Marketing Authorisation Applications (MAAs), Clinical Trial Applications (CTAs), and CTD Module 2 and Module 3 quality dossiers for biological products within the EMA framework. She later joined **BioNTech SE** as a Global Regulatory Affairs CMC Manager, supporting global CMC strategy and lifecycle management for vaccines and other biologics.

She has also collaborated with the World Health Organization (WHO) on regulatory capacity-building initiatives and is now Founder and Principal Consultant at MP BioReg Consulting, advising pharmaceutical and biotechnology companies on CMC development, CTD dossier preparation, and global regulatory strategy across EMA, FDA, and WHO pathways.