Join us for an expert-led overview of what you need to know in order to market drugs in the U.S. and to keep FDA off your back. This webinar features leading practitioners from the law firm of Hyman, Phelps & McNamara (HPM), the largest firm specializing in FDA issues, who will provide an overview of FDA laws, what typically goes wrong in regulatory strategies and submissions, and best practices to ensure that you get to market in the U.S. rapidly and remain in compliance with applicable laws. Leading practitioners from Torys LLP will also contrast Canadian laws with U.S. laws.

Discussion topics include:

• Categories of drugs by regulatory classification
• Clinical development
• Ways to fast-track a submission
• Compliance and enforcement considerations

Moderator:

Eileen McMahon, Partner and Chair, Intellectual Property and Food and Drug Regulatory Practices, Torys LLP

Speakers:

• Bob Dormer, Director, Hyman, Phelps & McNamara, P.C.
• Mark Schwartz, Director, Hyman, Phelps & McNamara, P.C.
• Josephine Torrente, Director, Hyman, Phelps & McNamara, P.C.
• Teresa Reguly, Partner and Registered Patent Agent, Torys LLP

To register please email at seminars@torys.com.