Driving the Execution of Cannabis-Based Clinical Trials

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The FDA’s recent approval of the first prescription cannabis-based product has prompted increased enthusiasm for development of related therapeutics. The regulatory landscape surrounding the development of cannabis components and their use in clinical trials is dynamic and poses many challenges, making effective management and navigation of the regulatory pathways essential to successful study delivery.

Sponsors and CROs often face hurdles in obtaining the necessary approvals for operationalizing clinical trials for controlled substances, including Schedule 1 drugs like cannabis and its components. Furthermore, in the United States, sponsors are seeking optimal ways to engage the FDA regarding development of such products. In this webcast, we’ll examine the current state of cannabis research and explore regulatory pathways and requirements to support such product development.

Topics will include:

  • The regulatory landscape and FDA engagement strategies for the development of cannabis-based products.
  • Site selection and start-up
    • Requirements for controlled substances in countries outside the U.S.
    • U.S. requirements for Schedule 1 drugs: state and DEA licensing pathways
    • Site security provisions
  • Logistics
    • Site security provisions
    • Drug ordering

Key Learning Objectives:

  • How to navigate the regulatory landscape and FDA engagement strategies for the development of cannabis- based products
  • The requirements within and outside of the U.S. for site selection and study start-up in cannabis-based studies
  • The logistical aspects in cannabis-based studies

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Title: Driving the Execution of Cannabis-Based Clinical Trials

Date: Tuesday, October 23, 2018

Time: 11am EDT | 10am CDT | 4pm BST | 5pm CEST

Duration: 60 minutes

Featured Speakers:

  • Nach Davé, Vice President, Global Regulatory Affairs, Premier Research
  • Meghan Shea, Regulatory Start up Manager, Study Start-Up, Premier Research
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