Overcoming Regulatory and Quality Concerns for Cell and Gene Therapies

Description

Learn to navigate the regulatory and quality landscape for CGTs/ATMPs.

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This training course will provide you with a complete understanding of the regulatory and quality requirements for cell and gene therapies in the EU and US. Once completed, you will know the regulatory requirements and quality data required in clinical applications and the Common Technical Document (CTD). With a complete understanding of the regulatory routes to market in the EMA and FDA, you will have the confidence to devise a regulatory strategy for your CGT product.