FDA Accelerated Approval Pathways for Cell and Gene Therapy Products

Speaker: Monica M. Commerford, Ph.D.

Brief description of the webinar:

Understanding the regulatory landscape is essential. It is changing as fast as the industry is changing. In this webinar you will get a clearer understanding of:

– Clear understanding of Viral Vector Gene Therapies (VVS) and the future of innovation
– The evolving regulatory landscape and why risk assessment is so important in VVS and the need for scalable QMS
– FDA services and opportunities for early engagement, expedited programs and the issuing of new cell and gene therapy
– Recent FDA Cell and Gene Therapy Guidance, streamlining of product development
The need to be creative during COVID restrictions what does that mean for you, your client, and regulatory obligations.

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