Clinical Trials: Regulatory Key Considerations and Clinical Operations (FIH Pathway scenario)

Are you planning and intend to start clinical trials for your ATMP? Do you need support setting the strategy and learning about potential routes/pathways to start human clinical trials?

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In this short webinar, the Cell and Gene Therapy Catapult will provide a high-level overview of the different components required to place an advanced therapy developer in a position to apply for a first-in-human / Phase I Clinical trial authorisation (CTA). This webinar is the second 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

What we will cover:

  • The CMC, clinical, non-clinical and regulatory key considerations needed to maximise success of a clinical trial application
  • Key points to bear in mind when planning a UK/EU CTA strategy including ethics and timelines
  • Grants available to provide funding of clinical trials and what you should have in place prior to applying to them
  • Hear from a collaborator on their experience of taking a product through to first-in-human/phase I clinical trial

Who should attend:

Academics, researchers, early-stage SMEs and companies in the cell and gene therapy industry, that are currently in the pre-clinical phase and are trying to shape their regulatory strategy / clinical development program to get to first in-human clinical trials.