Falls Church, VA (PRWEB) July 24, 2017
Right now, behind closed doors, the FDA is figuring out how to change manufacturers future.
The agency is hammering out a game plan to implement changes and compromises mandated under the 21st Century Cures Act, one of the farthest-ranging laws ever to affect FDA-regulated firms. The new law:
- Seeks ways to regulate cutting-edge cures and technologies such as biomarker-based drug applications, breakthrough device applications and combination products
- Targets specific diseases such as cancer with a brand new oncology coordination process
- Revamp the role of the Office of Translational Sciences in overseeing the lab-to-cure process
- And this barely scratches the surface.
Manufacturers need to know what’s in the 21st Century Cures Act and how it will affect them.
In 90 fast-paced minutes, Prof. Jim O’Reilly of the University of Cincinnati College of Law will reveal current FDA thinking and touch on the gut issues affecting makers of drugs, devices and biologics, operators of clinical trials and every other health science company under FDA jurisdiction. Expect this webinar to help manufacturers:
- Understand how FDA Science Board's new standards can lead to much faster product development approvals
- Develop best-in-class qualified data summaries can get products to market faster
- Gain faster agency approval of biomarker-based drug applications and breakthrough device applications
- Better navigate device and drug channels toward approval of new combination products
- Understand how the new oncology coordination process will impact product development
- Understand how the FDA will allocate its $500 million in funding to affect products directly
- Understand the new role of the Office of Translational Sciences, which governs the bench to clinical process
- And much more!
Discover how to navigate the brave new regulatory world to come.
Meet the Presenter:
Jim O’Reilly Esq. teaches food and drug law at the University of Cincinnati College of Law. The author of 53 texts and 215 articles, he was quoted in a 2000 Supreme Court ruling as “the expert” on medical-device law. He chairs the FDA Committee of the American Bar Association; serves on the Editorial Advisory Board of FDLI’s Food and Drug Law Journal; and is the longtime program chair of FDLI conferences.
Who Will Benefit:
- Planning/corporate strategy
- Regulatory affairs/compliance
- Quality by Design executives
- Manufacturing executives
- Legal counsel
FDA’s Work Plan ... the 21st Century Cures Act ... and You:
Disruptive? Absolutely. But ... How Much?
**An FDAnews Webinar**
Aug. 14, 2017 — 1:30 p.m. – 3:00 p.m. ET
$287 per site
Easy Ways to Register:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.