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 Me Read more
The FDA has approved three cannabinoids as drugs. In this webinar the focus will be on the FDA Meeting on May 31, 2019 Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing, and published reactions to it. The current market for CBD will also be discussed.The agency approved Epidiolex (cannabidiol or CBD) oral solution for the treatment of seizures associated with two rare, severe forms of epilepsy.
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.
This session will include what all statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
• Overview and general information on cannabinoids
• Cannabis as a 'dietary supplement'
• Grounds for the recent approval of Epidolex
• Legal and Illegal marketing of Cannabidiol (CBD)
• Research being conducted on CBD
• How to obtain research information
• Cannabis as 'food'
• Regulatory and future trends for cannabinoids in the United States
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Pharmaceutical Executives
• Pharmaceutical Research and Development
• Pharmaceutical Regulatory Affairs
• Food Research and Development
• Food Executive
• Quality Professionals
• Regulatory Compliance Officer