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.

6 & 7 July 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

29 May 2026 | 1:00 PM | 60 mins

Delivered Online

Understanding the Regulatory Landscape for Generic Medicines

• Understand what defines a generic medicine under EU and US regulation.
• Learn the key differences between the EU and US submission routes.
• Grasp the fundamentals of the 8+2+1 data exclusivity rule and its impact on launch strategy.
• Recognise the main regulatory procedures (Centralised, Decentralised, MRP, ANDA, 505(b)(2)).
• Appreciate the importance of developing a Right-First-Time regulatory strategy to remain competitive.

Register For Module 1 | Free

Day 1

Introduction and Market Context

• Current overview of the European generics market
• The impact of Directive 2004/27/EC on regulatory approval
• Key amendments to Directive 2001/83/EC

Regulatory Procedures in the EU

• Overview of Centralised, Decentralised, and Mutual Recognition Procedures
• When each procedure applies
• Advantages and disadvantages of each route
• Practical timing and workflow considerations

Data Exclusivity and Future Developments

• Understanding the 8+2+1 formula for data and market protection
• How exclusivity influences submission planning
• Anticipating future regulatory changes in Europe

US Regulatory Pathways for Generics

• Overview of the FDA framework for generic submissions
• Criteria for ANDA applications
• Understanding the 505(b)(2) hybrid route
• Hatch–Waxman Act provisions and exclusivity periods
• Paragraph IV certifications and litigation risks
• Case examples and lessons learned

Comparing EU and US Regulatory Approaches

• Strategic considerations for global development
• Common differences and challenges across regions

Interactive Workshop

• Case study: selecting the optimal procedure for a generic product
• Discussion: pros and cons of EU procedures in practice

Day 2

Patents, Trademarks, and Legal Frameworks

• Overview of patent protection for generics in the EU and US
• The Bolar exemption and TRIPS legislation explained
• Exceptions to patent law and practical applications
• Recent reforms to the Hatch–Waxman provisions
• Managing intellectual property risks during development

Developing Global Regulatory Submissions

• Key requirements for global generic authorisations
• Overview of CTD Modules 1–3 for generics
• BE/BA testing requirements in the EU and US
• Common regulatory challenges in dossier preparation

Developing “Right-First-Time” Generics

• Building a robust regulatory and development strategy
• Aligning CMC, clinical, and regulatory activities
• Ensuring data consistency across global submissions

Practical Workshop: Creating a Generic Development Plan

• Group exercise: designing a stepwise development and submission plan
• Identifying risks, timelines, and decision points
• Discussion of best practices and common pitfalls

Future Outlook for the Generic Industry

• Trends shaping future regulatory strategies
• Evolving guidance, new technologies, and market dynamics
• Final Q&A and key takeaways

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.