The disruptive nature of cell and gene therapies means that the need for advice and assistance in the regulatory area is particularly high. In this webinar the team at Cell and Gene Therapy Catapult will address how best to go about gaining early regulatory advice and how to engage with regulators globally, drawing on their own experiences.
During the webinar they will discuss:
- Regulatory classifications for advanced therapy medicinal products (ATMPs)
- What are the non-clinical safety considerations when developing ATMPs and when should you engage with regulators?
- How to gain early regulatory advice and the role of the regulators (MHRA, FDA and EMA).
- An example from our own experience in developing an immuno-oncology cellular therapy based on gene modifying T cells to target solid tumours.
The 45 minute presentation will be followed by a 15 minute Q&A session with the speakers.
The CGT Catapult team will also be joined by Ian Rees, Manager for the Inspectorate Strategy and Innovation Unit, MHRA, for the Q&A session.