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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