Simplifying Global Compliance
The 21st Century Cures Act — Impact on Pharmaceuticals - Webinar CD/Transcript
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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:
- How Congress has thrown a curve at the FDA’s often stringent review process, enabling far broader acceptance of submitted experience data
- How to add new "real world evidence" and "data summaries" into submissions
- How to benefit from Congress' locking FDA into development agreements
- How to avoid supplemental NDAs on new indications by pitching to insurers for their provider formularies without FDA control
- How to utilize patient input and patient experiences in pre-approval submissions
- How to accelerate approval of your new uses for drugs and still stay in compliance with current FDA regulation and guidance
- How to develop cutting-edge strategies to maximize the numerous opportunities for more rapid drug development under the Cures Act and not fall behind your competition
- How to accelerate with review vouchers and orphan drug grants
- How the elimination of local IRB approvals will accelerate approvals to the FDA
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.
- Regulatory affairs professionals
- Product lifecycle managers
- Approval and submissions specialists
- Medical affairs
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.
