Regulatory, Developmental and Manufacturing Challenges for ATMPs

• Consider the current regulation in Europe and globally and investigate new developments;
• Evaluate possible regulatory avenues for your product;
• Build on your understanding of quality control for ATMPs, including testing, oversight of materials and release;
• Confirm GMP manufacturing standards for ATMPs and make practical preparations for inspections;
• Reflect on common preservation and shipping issues for ATMPs and discuss using case studies;
• Gain guidance on the Investigational Medicinal Product Dossier for an ATMP and what should be included;
• Optimise your preparations for clinical trials

Andrew Willis – Day 1 – Regulatory & Quality

Regulatory and Development consultant with 30 years of experience. Andrew’s 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. He currently delivers extensive training courses available 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.

Alison Wilson – Day 2 – Manufacturing and Development

Alison is an independent consultant. She has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. Her current consultancy services include: providing strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products, regenerative medicine therapies and drug-device combination products in the EU.

This course is designed for professionals interested in the area of ATMPs, or already working in it. The following departments may have a particular interest:

• Regulatory affairs
• Quality assurance
• Quality control
• Manufacturing
• Bioprocessing
• Clinical development