Course Information

Course Information

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

7 December 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

180 mins | 9:30 AM UK

Introduction & What is Regulatory Due Diligence?

• Legal, business, and regulatory perspectives
• In-licensing vs in-house development
• Development timelines (PSC Levels 0–3)

Regulatory Due Diligence for New Submissions

• CTD/eCTD requirements and pitfalls
• Using the CQA Pyramid and CTD Equation
• CTD Module structure, Module 3 as “house of cards”
• QbD and Control Strategy linkages

Tools and Techniques for Due Diligence

• Gap analysis, compliance checklists
• Linking CQAs, CPPs, QTPPs across the CTD
• Case examples of common dossier deficiencies

Session 2

180 mins | 1:30 PM UK

Drug Substance & Drug Product Due Diligence (Module 3 focus)

• Drug substance (S.1–S.7): manufacturing, impurities, CEP/EDMF/DMF routes, reference standards, stability
• Drug product (P.1–P.8): formulation, manufacturing, control strategy, packaging, stability
• Specifications: ICH Q6A/B → Q6(R1) updates

Combination Products & Device Elements

• Article 117 MDR and NB Opinions
• Usability/human factors, compatibility studies
• Container closure and extractables/leachables

Regional Differences (EU vs US)

• Key divergences in dossier expectations
• FDA vs EMA approaches to data, validation, stability

Practical Workshop & Case Studies

• Hands-on dossier assessment: identifying gaps, risks, and regulator red flags
• Applying checklists to product examples

Wrap-Up & Takeaways

• Due diligence checklists for practice
• 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.