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The 21st Century Cures Act — Impact on Pharmaceuticals: What You Need to Know to Thrive in 2017
What do you need to know about the 21st Century Cures Act in order to thrive this year?
The passage of the 21st Century Cures Act aims to boost research and ease drug approvals. It will have you scrambling to meet new mandates… regulations and guidance in several key areas — including data development and maintenance, technical support, clinical approvals and pre-approval submissions, development agreements, inspections and reviews, supplemental NDAs, IRBs…and much, much more.
So why not join legal expert Jim O’Reilly for a discussion on the biggest change in the daily activities of the drug regulatory community in five decades.
After attending this incisive 90-minute session, you’ll understand:
Order today and learn what has changed with the 21st Century Cures Act and what you need to watch for in your submissions to the FDA.
Jim O’Reilly, Retired Law Professor, University of Cincinnati College of Law
Longtime food and drug law professor Jim O’Reilly was quoted by the U.S. Supreme Court in a 2000 FDA medical device case as “the expert” on device law. He is the last surviving member of the small group which negotiated in 1975-76 for the Medical Device Amendments, and his 3-volume treatise for West “Food & Drug Administration” is used around the world by regulated firms. He chairs the FDA Committee of the American Bar Association and served for many years as program chair for conferences produced by the Food and Drug Law Institute. He served on the Editorial Advisory Board of FDLI’s Food and Drug Law Journal and has published 53 texts and 215 articles.
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