The UCL TRO are holding an event where ERA Consulting will share their expertise on the translation of therapeutics to clinical application. Their expertise is ATMPs (Advanced Therapy Medicinal Products) and biologics, and for this workshop they will focus on ATMPs.
When: Tuesday 27th November 2018, 12.00-4pm
Where: South Quad Pop Up Learning Hub (This is a NEW Location)
Who: This event is restricted to UCL staff and students only. Please register using your UCL email address.
The sessions are designed to provide attendees with a regulatory scientific approach for successful translation of ATMPs into the clinic. We will aim to provide an understanding of pre-clinical development pathways and requirements for ATMPs leading to the most expedited regulatory strategy in Europe, the US and beyond. Potential challenges in the development and registration of these products will also be discussed, to provide practical advice as well as highlight key aspects determining successful regulatory submissions.
• The value of regulatory strategies in the early development of ATMPs
• CMC issues that impact the development of gene and cell therapy programs
• Challenges in pre-clinical development of ATMPs
• Assay development
• Toxicology studies and their design
For more information please sign up to the registration page.