2023 Pre-Conference Workshop II

Sunday, May 14, 2023

4:15 pm PDT
(tentative time)

Psychedelics & Clinical Trials: Site Feasibility and Audit Preparedness

FDA-approved clinical trials are critically important for psychedelics to becoming accepted and recognized as substances with approved medical use. Psychedelics such as MDMA and psilocybin are approaching federal regulatory approval for use to treat depression, anxiety, and a variety of substance use disorders. Many innovators and scientists are interested in running clinical trials in order to prove safety and efficacy and as a necessary step to eventual commercialization. The speakers will provide an overview of current psychedelic clinical trials for certain mental health and behavioral health treatments, outline some of the requirements for clinical site feasibility, licensing requirements that sponsors will need to bear in mind when choosing a clinical trial site, the challenges of running and operating clinical trials for Schedule I drugs, and areas of concern in order to be prepared for a clinical site audit.

Learning Objectives:

⇒ Learn about licensing requirements for clinical sites.
⇒ Learn about agreements with Contract Research Organizations, who will be running your clinical trial.
⇒ Be introduced to an analysis framework to help trial sponsors consider various clinical trial sites and determine which sites are feasible.
⇒ Identify issues that may come up in an audit and could shut down your clinical trial.
⇒ Identify potential fraud and abuse risks around clinical trials reimbursement.
Workshop Leaders
Sabrina Ramkellawan, CCRP, CCRA
Sabrina Ramkellawan, CCRP, CCRAChief Operatiing Officer & Co-Founder
Axial Bridge (formerly known as Knowde Group)
Karen Luong, JD
Karen Luong, JDSenior Counsel
Husch & Blackwell
Kimberly Chew, JD
Kimberly Chew, JDSenior Counsel
Husch & Blackwell
Natasha Sumner, JD
Natasha Sumner, JDSenior Counsel
Husch & Blackwell

About Us

Arrowhead Conferences offer an experience that encompasses learning, networking and professional growth. We focus on bringing life sciences industry professionals together to help move research forward.


Contact Details

+1 866-945-0263


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