Speakers

Matthias Zerm, Raquel Vaquer-Pérez, Shalini Dwivedi

Date

May 3, 2023

Time

9:00 - 10:00 AM EDT

One year of CTIS: Experience, learning, and perspectives of large and small sponsors and service providers

Under EU-CTR 536-2014 all new Clinical Trial Applications (CTAs) in the EU must be submitted through the EMA’s Clinical Trial Application System (CTIS). Clinical trial sponsors must make significant changes to their processes and operating models to comply with the regulations and use of CTIS.

Our presenters, from a large US-based pharma, a smaller EU-based pharma and a service provider, will present their perspectives on adapting to the new regulation. The panel will provide insights into challenges they have faced with CTIS and best practices emerging to manage these. Attendees will have the opportunity to submit questions to the panel during the live webinar.

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