Overview of current GMO regulatory landscape: challenges and learnings from practical experience
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Are you a cell and gene therapy developer looking for help with navigating the complex regulatory landscape? Do you wish to learn more about how to develop a successful GMO strategy?
In this short webinar, the Cell and Gene Therapy Catapult will provide an overview of the UK / EU GMO regulatory landscape and provide high-level insight on the common challenges associated with GMO submissions. This webinar is the first in a two part series, aimed at helping those in the cell and gene therapy industry to successfully address the main challenges faced across the unique and complex regulatory landscape for ATMPs.
We will present a high-level overview on the:
- Evolution of legislation from past to present
- Common challenges associated with GMO submissions and proposed solutions
- Learnings based on practical experience of operationalising a GMO strategy to support a clinical development program
- CGT Catapult’s perspective on best practice to developing and delivering a GMO strategy
- Hear from a collaborator on their GMO experience on what worked well, what didn’t and any tips for those embarking on the journey to CTA
Who should attend: Academics, researchers, SMEs and other pharmaceutical companies working in cell and gene therapies development, interested in learning more about the GMO regulatory landscape and experience insights to the challenges associated with GMO requirements for clinical trials.