Effective Implementation of the Revised EMA First-into-Human (FiH) Guidance to Accelerate Your Early Clinical Development
In this webinar the speakers 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 other agencies.