Live Online Training Information

The training starts at 9.00 am UK time and finishes approximately 4:00 pm / 5:00 pm on each day. For online attendees, you will receive joining instructions.

1 & 2 October 2026

2-Day Live Online Training

Register at the top of the page. The largest price saving of £400 will be applied.

Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

4 September 2026 | 1:00 PM | 60 mins

Delivered Online

Understanding CMC and Regulatory Foundations for Biosimilars

•  Understand the fundamental differences between biologics, biosimilars, and generics.
• Explain why “the process is the product” in biosimilar development.
• Identify key CMC and analytical comparability challenges.
• Recognise the global regulatory framework for biosimilars (EMA, FDA, WHO).
• Appreciate the importance of Module 3 (Quality) in biosimilar submissions.

Register For Module 1 | Free

There are limited spaces on module 1. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Day 1

Introduction to Biologics and Biosimilars

• Definitions: biologics vs biosimilars vs generics
• Structural and functional complexity of biologics
• Why “the process is the product” for biosimilars
• Key differences in development approaches (generics vs biosimilars)

Global Regulatory Frameworks

• EMA, FDA, and WHO biosimilar guidelines
• Stepwise development paradigm: quality, non-clinical, and clinical data
• The role of ICH guidelines in biosimilar submissions
• (e)CTD and the importance of Module 3 for biosimilars

CMC Considerations for Biosimilars

• Analytical comparability and extensive characterisation
• Quality by Design (QbD) and control strategies
• Critical Quality Attributes (CQAs) and process consistency
• Specifications, impurities, stability, and reference standards

Module 3 for Biosimilars (Part 1)

• Structure of Module 3 (drug substance & drug product sections)
• Key differences between innovator biologics and biosimilar dossiers
• EMA/FDA expectations for Module 3 documentation
• Practical insights: deficiencies commonly identified by regulators

Day 2

Module 3 for Biosimilars (Part 2)

• Section-by-section review: 3.2.S (Drug Substance) and 3.2.P (Drug Product)
• Manufacturing process control, process validation, and comparability
• Analytical method validation and lifecycle management
• Linkages to Module 2 (Quality Overall Summary)

Additional Regulatory Topics

• Interchangeability: scientific and regulatory perspectives
• Naming, labelling, and pharmacovigilance considerations
• Non-comparable biologics: regulatory and scientific challenges

Challenges and Strategies in Biosimilar Development

• Development costs, timelines, and uncertainty
• Global development strategies: EU, US, Japan, emerging markets
• Case examples: lessons from biosimilar approvals and rejections
• Strategic considerations for sponsors (partnerships, lifecycle planning)

Case Study & Wrap-Up

• Interactive case study: assessing a biosimilar development plan
• Identifying CMC risks and regulatory challenges
• Key take-home messages and final Q&A

Andrew Willis is a regulatory and development consultant with 35 years of experience. His management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.

Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.

Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. More recently for IO Biotech, Andrew was SVP of Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place.

He currently delivers extensive training courses in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.