A Webinar Presented by OFW Law and Davis, LLP
October 15, 2014, 1:00 p.m. EST
During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:
- Requirements for drug importation into the U.S. and Canada
- Pharmaceutical market approval pathways in both countries
- Pharmaceutical manufacturing controls in both countries
- Pricing of brand and generic pharmaceuticals in Canada
- Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
- Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
- Inspections and enforcement
The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.
To register for the webinar, please visit www.cvent.com/d/14qf66.
To view or share this information as a PDF, please click here.
About the presenters:
Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act. She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA). Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market. She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.
Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions. She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.
