Bruno Speder, VP of regulatory affairs & consultancy services, hVIVO, discusses how Human Challenge Trials (HCT) can be used in the framework of expedited review programs as part of drug and vaccine development.
Bruno Speder, SGS Life Sciences, gives an overview of new EU regulation 536/2014, introduced to provide a single European submission and approval procedure for clinical trials, and discusses the effects it may have on early phase clinical trials
