If you’re looking for fast-track training, I am co-chairing a conference that you may be interested in: American Conference Institute’s Legal, Regulatory & Compliance Forum on Controlled Substances. The conference is in DC on January 16-17 and will provide training in core regulatory concepts dealing with DEA-scheduled pharmaceutical products. Additional details below. To view the agenda and/or register, go to: www.americanconference.com/ControlledSubstances. ___________________________________________________________ ACI’s Legal, Regulatory & Compliance Forum on Controlled Substances will respond to the needs of the industry amidst all of these changes. Learn from former and current DEA officials, including Wendy Goggin, Chief Counsel of DEA, who just joined the faculty, in-house industry counsel, and outside counsel regulatory experts who will cover the most pressing topics facing the industry. In fact, there is a session specifically devoted to addressing efficiency strategies when navigating the approval process and scheduling drugs, with topics including:
- What does it take to get a controlled substance through the approval process?
- Getting new molecular entities scheduled and on the market in a timely manner
- What is FDA’s role in the scheduling of a controlled substance?
- Removing or lowering the schedule of a listed drug
- Drafting tips for preparing a submission that will move quickly through the scheduling, registration, and approval processes
The program offers much more to give you a well-rounded understanding of all facets of controlled substances regulation and enforcement. The expert faculty will provide you with unparalleled insight into abuse resistant formulations, responding to DEA investigations, and much more. Plus, complete your experience by attending the Pre-Conference Regulatory Primer and Post-Conference Master Class:
- The Pre-Conference Regulatory Primer, “Fundamentals of Controlled Substances Regulations: DEA, FDA, and State Laws” will provide you with an introduction to FDA and DEA regulations governing controlled substances and will prepare you to seamlessly flow into the more advanced discussions that will take place during the main conference.
- The Post-Conference Master Class, “Creating a Comprehensive Compliance Program that Accounts for Different Regulations for Listed Chemicals vs. Controlled Substances” provides advanced guidance on another heavily regulated area that goes hand-in-hand with controlled substances. Build on the knowledge gained during the main conference and learn about all facets of controlled substances regulation, including the component chemicals that comprise pharmaceutical products.