The 21st Century Cures Act — Impact on Pharmaceuticals - Webinar CD/Transcript
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.