Regulatory Requirements for Drug Development Research
Amy Emerson and Michele Weitz are both experienced in the global conduct of clinical trials, which are a crucial part of conducting psychedelic research in human subjects. They presented an overview of the responsibilities of investigators while conducting clinical trials based on International Conference of Harmonization Good Clinical Practice (ICH-GCP) guidelines set forth by the Food and Drug Administration (FDA) and European Medicines Agency (EMEA). They discussed how regulations apply to different types of clinical trials through a review of the top FDA ﬁndings in audited clinical trials and warning letters other Investigators have received.
This video is from Psychedelic Science in the 21st Century, a conference taking in place in San Jose, California on April 15-18, 2010. The conference was organized by the Multidisciplinary Association for Psychedelic Studies (MAPS) in collaboration with the Heffter Research Institute, the Council on Spiritual Practices, and the Beckley Foundation.
This video was produced by Green Fuse Media, contact Nathan at email@example.com
To learn more about MAPS or to support our work, visit http://www.maps.org.