Effective Implementation of the Revised EMA First-into-Human (FIH) Guidance to Accelerate Your Early Clinical Development, New Webinar Hosted by Xtalks
TORONTO, ON–(Marketwired – December 14, 2017) – In this webinar speakers from Simbec Research will discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency.
Attendees will learn how to combine multiple standard trials in one protocol, including SAD, MAD, food effect, age and gender, and efficacy in patients.
In addition, key aspects of the revised EMA First-in-Human guidance will be considered in order to design suitably-flexible protocols to avoid unnecessary regulatory delays. Pros and cons of conducting early phase research in the EU will also be discussed, along with the acceptability of clinical trial data from trials run in the EU by the FDA.
Join the live session on Tuesday, January 16, 2018 at 10am EST (3pm GMT) with Dr. Annelize Koch, Medical Director and Dr. Simon Hutchings, Director of Scientific Affairs.
For more information or to register for this complimentary event visit: Effective Implementation of the Revised EMA First-into-Human (FIH) Guidance to Accelerate Your Early Clinical Development.
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