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Navigating a Complex Regulatory Landscape

Join us!

December 6, 2018
5:00 p.m. to 7:00 p.m.
WeWork
600 California Street
San Francisco, CA
Food will be served.

Agenda
5:00 p.m. to 5:30 p.m.
Registration and Networking

5:30 p.m to 6:30 p.m. 
The Clinical Utilization of Cannabinoid Containing Compounds in the US: Navigating a Complex Regulatory Landscape

6:30 p.m. to 7:00 p.m. 
Q&A / Closing

Although cannabis is now legal in many US States both for medicinal and recreational use, the regulations governing the marketing, distribution, and use of cannabis within these two spheres are quite different. This regulatory difference is likely to have profound implications for the way that these markets evolve going forward. Join us for a workshop to explore the regulatory outlook around the use of cannabinoid-based products in the United States.


Led by Dr. Steve Amato, Director of Northeastern University’s Graduate Programs in Regulatory Affairs, the workshop will:


> Survey the range of ailments for which medical cannabinoid products are currently prescribed, as well as ailments that might be treatable with cannabinoid products in the future
> Navigate the regulations that currently apply to medicinal cannabis in the United States, as well as the laws and policies governing its distribution and reimbursement
> Explore how the medicinal and recreational use of cannabis containing compounds may impact their daily professional lives through breakout sessions and discussions


About the Speaker - Dr. Steve Amato

SteveAmato.pngDr. Stephen F. Amato has over 25 years of experience in the pharmaceutical, biotechnology and medical device industries. Prior to his position as Faculty Director of Graduate Regulatory Affairs and Life Sciences at Northeastern University, Steve was the Founder and Managing Director of tJun17 Life Sciences Advisors, LLC, and also a Managing Director for Cardinal Health Regulatory Sciences. Additionally, as an Executive with GfK Health, Dr. Amato managed and worked on client global regulatory affairs and reimbursement projects in the areas of market access, pricing, and payer coverage, coding and payment strategy. Prior to GfK Health, as an Executive Director at Anika Therapeutics, Steve managed all aspects of the company's product portfolio including regulatory, reimbursement, market segmentation, targeting, positioning, pricing and promotional strategies.


From 2000 to 2007, he was the Group Director of Knee Repair at Smith & Nephew Endoscopy where he managed a $140M orthopedic product portfolio. Earlier in his career, Steve worked for Visible Genetics, where he was responsible for developing and launching genomic molecular diagnostics products used for subtyping Human Papilloma Virus (HPV) and other infectious disease agents.  He has also worked with Critical Therapeutics on the development and commercialization of treatments for gram-negative sepsis.


Steve holds an AB in Biochemical Sciences from Harvard University, a Ph.D. in Molecular and Cellular Biology from Boston College’s Graduate School of Arts and Sciences, and an MBA from the Carroll School of Graduate Management at Boston College. He has also received the U.S. and EU Regulatory Affairs Certification designations and is a Consultant for the Regulatory Affairs Professional Society.


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About Northeastern

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