20 November - 15:00 - 16:00 GMT / 16:00 – 17:00 CET
Key scientific developments and regulatory considerations for Cell and Gene Therapies
The significant potential of cell and gene therapies is tempered by the mismatch between traditional regulatory paradigms and the nature of these therapies, along with the need for innovative clinical trial designs, ethical considerations, and manufacturing complexities. Consequently, regulatory agencies have adopted a cautious approach to the oversight of cell and gene therapies, shaped by respective public health priorities, economic conditions, and healthcare systems. This session will focus on the obstacles faced when navigating regulations worldwide. It aims to evaluate market dynamics and emerging trends, how regulatory authorities are providing guidance, fostering collaborations, and establishing dedicated review pathways to facilitate development, and what changes to regulations can be expected in the European Union. As a bonus, we will also take a closer look at how to realize the immense potential of gene editing within the regulatory landscape.
Speakers

Sofia Ataide, Senior Business Solution Consultant
Sofia holds dual Master's degrees in Pharmaceutical Sciences from the University of Lisbon and International Health Management from Imperial College Business School. With nearly seven years of experience at Clarivate, she has demonstrated excellence across various roles in Sales and Strategic Partnerships. In her current position as Senior Solutions Consultant, Sofia applies her extensive domain expertise and technical proficiency in Clarivate’s Clinical, Regulatory, and CMC solutions to deliver impactful, business-oriented strategies to clients.

Kush Mukherjee, Senior Consultant, Regulatory
Kush holds a Bachelor's degree in Biotechnology and a Post Graduate Diploma in Management. He has more than eighteen years of experience in intelligence, consulting and account management in Pharma, Devices and Consumer industries. Having four years of experience now at Clarivate and domain expertise in regulatory intelligence, he has been instrumental in not only demonstrating our regulatory and clinical consulting offerings to clients, but also expanding our consulting services and expertise to new and niche areas and geographies.

Disclaimer: Whilst TOPRA is running this webinar for Clarivate, this is not an endorsement of Clarivate, Clarivate's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.
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