PrimeRA Regulatory Office Hour

​A free, monthly Q&A session on the development of cell and gene therapy with a primary focus on regulatory affairs, hosted by PrimeRA Pharma Partners.

​From November, the PrimeRA team will host a free Regulatory Office Hour to answer any global regulatory questions you might have. Amongst some of the projects that our Partners have contributed to during their careers are the development, approval or maintenance of the first gene therapy approved in Europe, the first CAR-T cell therapy submitted for approval in the US, and the first CRISPR product approved globally and with all this knowledge will draw on their experience to provide guidance in a non-confidential setting. Bring your questions on strategy across the UK, EU and US, from whether your product is an ATMP, to what regulators expect on CMC.

​This is open to biotech developers, academic groups, institutions, spin-outs and early-stage companies. Questions sent in advance are taken first.

​Sean Russell, Managing Partner, will be leading the first session on Tuesday, 10 November at 15:00 UK time.

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​Please note: this is a group session and isn't confidential. It offers general guidance only. It is not formal regulatory advice, does not create a client relationship, and you remain responsible for your own regulatory decisions and submissions.

​Website: PrimeRA Pharma Partners
LinkedIn: PrimeRA Pharma Partners