This two-day course will provide you with a practical understanding of regulatory challenges, manufacturing concerns and clinical trial preparation for ATMPs.
Using case studies and relevant examples, the course will improve your understanding of the regulatory landscape and provide you with approval routes for your product. In addition, you will gain a comprehensive understanding of the principal difficulties in delivery and shipping, applying GMP in manufacturing and getting ready for clinical trial.
Delegates may choose to attend either one or both days of the course.
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 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:
"Good practical examples with experienced course leaders. The course material was excellent to use as a reference back at work." ~ Product Development Director, Xintela AB
I enjoyed the second day the most. The practical examples and experience shared by Alison were excellent." ~ Medical and Drug Safety Manager, Généthon
The focus on manufacturing/CMC challenges was great.
Alison's slides were really valuable - very good and varied examples given.