FDLI Introduction to Law and Regulation Drug and Medical Device: The New Approval Process: NDA Submission and Review


November 9, 2015

Introduction to Law and Regulation _ Drug and Medical Device

November 9-10, 2015 | Gordon & Rees LLP | San Francisco, CA

This unique combination course

will give participants a comprehensive overview of the laws and Food and Drug Administration (FDA) regulations affecting both the drug and medical devices industries. All attendees will benefit from expert speakers on topics including bringing new products to market, key principals in advertising and promotion, and enforcement considerations.

Breakout sessions for individuals interested in either the Drug or Medical Device track will benefit from industry specific topics, including Biologics and Biosimilars, Clinical Investigations and the New Drug Approval Process. Participants on both tracks will better understand key FDA regulations and policies as experts help you determine how those regulations and policies are applied. Attendees will have multiple opportunities to ask questions of the speakers, including those on developing issues affecting both the drug and device industries. This interactive, two-day course will be of interest for new professionals in the drug and medical device industries as well as seasoned regulatory affairs or legal professionals looking for a refresher on current FDA policies and practices.

All Attendees Receive

• FDLI’s Federal Food, Drug, and Cosmetic Act (FDCA) Statutory Supplement, 2013

• Complete Binder of Speaker Materials