Medical Cannabis: Overview of Emerging Legal Issues and their Impact on the International Market. The international panel of experts will notably discuss the differences in regulations between medical cannabis and pharmaceutical cannabis, how IP is becoming an essential topic with pharmaceutical cannabis medicines, and how it could also impact medical cannabis in the short run.
Credits
General
This program is eligible for 1 hours of General CLE credit in 60-minute states, and 1.2 hours of General CLE credit in 50-minute states. Credit hours are estimated and are subject to each state’s approval and credit rounding rules.
INCBA webinars are generally eligible for credit in the following states: AR, AL, CA, CO, GA, HI, IL, NJ, NM, NY, ND, PA, TX, VT. Additional states may be available for credit upon self-application by attendees. States typically decide whether a program qualifies for MCLE credit in their jurisdiction 4-8 weeks after the program application is submitted. For many live events, credit approval is not received prior to the program.
The on-demand version of this webinar is eligible for credit in the following states: AR, AL, CA, CO, GA, HI, IL, NJ, NM, NY, ND, PA, TX, VT. Additional states may be available for credit upon self-application by attendees.
(Default credit disclaimer updated 02.08.2024)
For current accreditation status, please select your jurisdiction below.
Handouts
01262023 FDA Regulatory Statement.pdf
(990.3 KB)
01262023 FDA Regulatory Statement.pdf
Available after Purchase
Document A -Cannabisarzneimittel.pdf
(118.2 KB)
Document A -Cannabisarzneimittel.pdf
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Document B - Circular 106.pdf
(1.5 MB)
Document B - Circular 106.pdf
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FDA and Cannabis_ Research and Drug Approval Process _ FDA.pdf
(376.4 KB)
FDA and Cannabis_ Research and Drug Approval Process _ FDA.pdf
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FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds _ FDA.pdf
(679.2 KB)
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds _ FDA.pdf
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FDA Regulation of Dietary Supplement Conventional Food Products Containing CBD Compounds (updated).pdf
(74 KB)
FDA Regulation of Dietary Supplement Conventional Food Products Containing CBD Compounds (updated).pdf
Available after Purchase
Medical Cannabis- Overview of Emerging Legal Issues and their Impact on the International Market.pptx
(1.9 MB)
Medical Cannabis- Overview of Emerging Legal Issues and their Impact on the International Market.pptx
Available after Purchase
OUTLINE - Medical Cannabis - Overview of Emerging Legal Issues and their Impact on the Intl Mkt.pdf
(418.1 KB)
OUTLINE - Medical Cannabis - Overview of Emerging Legal Issues and their Impact on the Intl Mkt.pdf
Ambassador Menahem (Chuck) Kanafi is an advocate and third-party neutral focusing on resolving cross-border commercial disputes with experience in India, the US, Israel, Africa and Germany. He studied law at the Hebrew University of Jerusalem and served as an Appellate Prosecutor and Senior Civil Law Counsel in government. Thereafter, Chuck embarked on a three-decades long diplomatic career including legal, political and UN functions, culminating with ambassadorial posts in Ghana, Eritrea and as Consul-General in South India.
Upon retirement from the Foreign Service, Chuck established himself in private collaborative legal practice concentrating on mediating disputes in international trade and legal aspects of the medical cannabis industry, specifically focusing on international commercial disputes. Chuck is admitted to practice in Israel and New York State and in Israel and maintains a presence in New York, Berlin and Tel Aviv. Chuck serves on the Advisory Boards of a number of educational ADR initiatives in India, has served as a judge in international mediation competitions, is a member of the International Committee of the International Cannabis Bar Association, and has moderated panels at their Cannabis Law Institute 2019.
Dr. Jayashree Mitra has represented clients in high-stakes litigation across a wide range of intellectual property, antitrust, and commercial disputes. Her clients span diverse industries, with a particular focus on the pharmaceutical sector. She has extensive experience in Hatch-Waxman litigation and has represented both brand-name and generic pharmaceutical companies in complex litigation before federal courts. She also has substantial experience litigating complex antitrust matters for clients in the pharmaceutical industry, including class actions and competitor lawsuits involving various federal, state, and common law claims.
In addition to her litigation work, Jayashree advises clients on transactional matters, especially where technology is a key component of the deal. She has assisted clients with drafting and negotiating technology agreements and provided deal support in complex mergers and acquisitions, joint ventures, and private equity matters. She also assists clients in building global patent and trademark portfolios and implementing innovative strategies to protect their intellectual property rights.
Jayashree is deeply engaged with emerging technologies. She has helped clients in the cannabis and psychedelic industries navigate the challenges of obtaining intellectual property rights from the U.S. Patent and Trademark Office, litigated cannabis-related patents in federal courts, and helped ensure compliance with FDA and DEA regulations. Jayashree is also a certified information privacy professional (CIPP) and advises clients on issues arising from the emergence of artificial intelligence.
Jayashree is committed to pro bono service and has handled criminal appeals and death penalty cases.
Prior to law school, Jayashree pursued a career in neuroscience and obtained her Ph.D. in pharmacology from Yale University. Her dissertation focused on the effect of prenatal cocaine exposure on the developing brain. Jayashree also worked as a medical writer, preparing scientific materials for major pharmaceutical companies.
Marie Sanchez is a lawyer at the Bars of Paris and Quebec. After beginning her career in Singapore with a large pharmaceutical group, she worked for nearly 10 years in renowned international law firms before founding NOOA Avocats.
A specialist in regulatory and contractual aspects related to life sciences, she has also developed expertise in the field of therapeutic cannabis and well-being hemp. She regularly intervenes in the context of training courses as well as in conferences, in France and abroad.
She holds a Master II Professional in Health Industry Law from the University of Montpellier I as well as an ESSEC-Mannheim Executive MBA.
Alejandro Luna joined Olivares in 1996 and became a partner in 2005. He is instrumental in the IP Litigation, Regulatory and Administrative Litigation practices and Co-chair of the Life Sciences & Pharmaceutical law and industry group and also he coordinates the litigation department. Mr. Luna has been crucial to the heart of Mexico’s intellectual property legal system as one of the few true patent regulatory and administrative litigation experts in Mexico. He acts on behalf of his clients as an attorney, and a lobbyist.
He has participated in questioning the constitutionality of certain provisions of the Industrial Property Law and the Federal Copyright Law. He is also the sponsor of an important proposal to modify the system of litigation and enforcement of intellectual property rights in Mexico.
He has incorporated regulation changes and lobbying which has resulted in precedent for patent linkage regulations and life terms of pipeline patents in Mexico. This work has resulted in US$ billions of protected revenues for the R&D pharmaceutical industry in Mexico. As a result of his involvement, he has been selected as the delegate to represent AMIIF, the industry association for R&D pharmaceutical companies who do business in Mexico, in the Trans-Pacific Partnership negotiations.
His practice is not solely devoted to Life Sciences; he represents clients across a myriad of industries. He has successfully litigated exclusivity for pharmaceutical patents and pioneered administrative court actions to seek recognition of DPE rights, which are not specifically contemplated by Mexican laws.
His commitment to just and fair law extends to his overall promise of client satisfaction; he lobbies to change the law to allow for proper patent protection and best serve his clients. Mr. Luna is also the author of several articles on patents, litigation and regulatory issues. He is a part-time professor at the Universidad Nacional Autonoma de México (UNAM).
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