In this webinar the speakers discuss the use of integrated protocols (umbrella protocols) to maximise programme efficiency.
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.
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Explore our related webinar – Phase I Studies in Patient Populations: De-risking Clinical Development by Obtaining Key Patient Data Earlier.
Read our blog on: Writing a protocol for clinical research