Course Overview

Regulatory success in biologics and vaccine development depends on far more than compiling a technically compliant dossier. Health authorities evaluate submissions through a complex scientific and risk-based lens, assessing not only the data itself but also the confidence it creates in the product, process, and organisation behind it.

This executive-level training course provides a practical and strategic insight into how regulatory assessors think when reviewing biologics and vaccine submissions. Participants will explore how authorities interpret CMC data, identify potential red flags, assess uncertainty, and make benefit-risk decisions during the review process.

Designed for professionals involved in regulatory affairs, CMC, quality, and biologics or vaccine development, the course moves beyond traditional regulatory training by focusing on regulatory mindset, assessor expectations, and real-world decision-making frameworks used by agencies such as the EMA, FDA, and WHO.

Through practical case studies, interactive discussions, and a regulatory decision simulation exercise, delegates will gain valuable insight into how to proactively strengthen submissions, anticipate authority concerns, and build greater regulatory confidence throughout development

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Key Learning Objectives

• Understand how regulatory assessors review biologics and vaccine submissions
• Explain the difference between regulatory compliance and regulatory confidence building
• Interpret how agencies evaluate CMC data and identify potential risk signals
• Recognise common biologics and vaccine development red flags that trigger regulatory concern
• Understand how benefit-risk decisions are made under conditions of scientific uncertainty
• Explore regulatory review approaches used by the EMA, FDA, and WHO
• Analyse how process changes, stability data, and manufacturing consistency influence regulatory perception
• Strengthen cross-functional regulatory strategies to improve submission quality and confidence
• Anticipate likely regulatory questions and objections during dossier review
• Apply assessor-style thinking through interactive biologics and vaccine case studies and decision simulations