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Webinars >>FDA Regulations
Legal and Regulatory Requirements for Cannabidiol (CBD) Based Pharmaceuticals and Related Products

Cannabidiol (CBD) is a highly regulated and highly attractive active ingredient of several products regulated by FDA, EMA and other regulators worldwide.

Now found in many products such as as cosmetics, dietary supplements, pet treats, vape pens, and investigational pharmaceuticals, cannabidiol (CBD) has clearly captured the attention of consumers and industry. Manufacturers, marketers, retailers, and consumers have shown increased interest in products containing cannabidiol (CBD). However, much confusion remains about the US and European legal and regulatory status of the ingredient, potential sources, and the various types of products in which companies include the ingredient.

CBD has also generated equal amounts of controversy and confusion. Chief among stakeholders’ concerns is the ingredient’s status under international law. The rules governing these products have several areas of confusion.

This session by expert speaker Dr. Mukesh Kumar will frame the issues in plain language, helping you understand the merits and vulnerabilities of these competing positions, the factors that matter in determining the status of a particular CBD-containing product, and the issues that remain unsettled.
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Topics Covered in the Session:
  • What cannabidiol is
  • The European, Canadian and other international regulations for such products
  • If CBD “marijuana” is subject to DEA enforcement
  • GMP Requirements for CBD based products
  • Discussion of “industrial hemp” and the “Farm Bill”
  • The status of a CBD product under US and European laws
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The session will focus on the requirements of the FDA, EMA and other regulators. You will be better informed to navigate the complex federal rules that determine the legal and regulatory status of CBD and various CBD-containing products. You will be better able to evaluate and mitigate the risks presented by certain CBD business opportunities. You will get risk-mitigation strategies for operating in the CBD industry, and understand the legal questions that remain unanswered and require continued monitoring. You will also gain the background needed to monitor and contextualize new developments in federal law, regulation, and policy impacting the CBD market.


Who will benefit:​
​

This webinar will provide valuable assistance to all personnel in:
  • Employees of manufacturers, distributors, and retailers of CBD products
  • Attorneys
  • Regulatory affairs specialists
  • Marketing professionals serving the industry
  • Investors
  • Entrepreneurs
  • Scientists
  • Government employees interested in learning more about regulation of the category
Date: September 20, 2018
​Duration: 60 Minutes
​Time: 12 PM EST
Register Online

Speaker: Mukesh Kumar
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PhD, RAC | Brij Strategic Consultations,  USA
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For additional information on the webinar and logistics, please call 410-501-5777 or email: info@fdamap.com

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