Cannabinoids – FDA and Clinical Trials

Product Id : FDA210
Instructor : Loren Gelber
Apr 04, 2019 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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The FDA has approved three cannabinoids as drugs. In 2018, the agency approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare, severe forms of epilepsy. This drug is derived from marijuana. The FDA has also approved the synthetic cannabinoids dronabinol and nabilone to treat nausea and vomiting associated with cancer chemotherapy in people who have already taken other medicines to treat these symptoms without good results.

Cannabinoids are a hot topic in the current pharmaceutical industry.  Knowledge of the current FDA approvals and research being reported will assist in predicting the future of this class of compounds and deciding whether a given firm wants to be part of it.

This webinar with regulatory compliance expert, Dr. Loren Gelber, Ph.D., will discuss the current status of cannabinoids as medical products in the United States.  The focus will be on what we can learn from the FDA approval of Epidolex (Cannabidiol) oral solution 100 mg/mL.  You will be provided guidance on how to obtain research information and understand the current market for Cannabidiol (CBD) in the U.S.

After attending this session you will get a better understanding of regulatory trends concerning CBD and to know what the future holds for cannabinoids.

Session Highlights:

  • Overview and general  information on cannabinoids
  • Grounds for the recent approval of Epidolex
  • Legal and Illegal marketing of Cannabidiol (CBD)
  • Research being conducted on CBD
  • How to obtain research information
  • The current market for Cannabidiol (CBD) in the U.S.
  • Regulatory and future trends for cannabinoids in the United States

Also Includes:

  • Live Q&A session with speaker
  • PPT presentation for reference
  • Certificate of attendance

Who Will Benefit:

  • Pharmaceutical executives
  • Research and development professionals in pharmaceutical companies
  • Regulatory affairs personnel in pharmaceutical companies
  • Food Executive
  • Quality Professionals
  • Regulatory Compliance Officer
Speaker Profile:

Dr. Loren Gelber has worked in the pharmaceutical industry for more than 40 years, at both the FDA and in private industry. She has been involved in numerous launches of OTC drugs and in Rx to OTC switches. Her specialty is compliance with US regulatory compliance. She has a BA in Biology, an MS in Chemistry and a Ph.D. in Medicinal Chemistry.

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