FDAnews Announces — Getting Real About Real World Evidence: Practical Next Steps for Drug and Device Manufacturers Webinar, Aug. 15, 2018
FALLS CHURCH, Va. (PRWEB) August 06, 2018 -- Getting Real About Real World Evidence:
Practical Next Steps for Drug and Device Manufacturers
**An FDAnews Webinar**
Aug. 15, 2018 — 1:30 p.m. – 2:30 p.m. ET
http://www.fdanews.com/realworldevidence
Real world evidence is pushing the FDA in new directions. The concept, often shortened to RWE, is affecting agency regulation in ways that range from overt to subtle even as it has a similar effect on the profits and opportunities facing drug, biotech and device manufacturers.
Some FDA-regulated manufacturers already are using RWE data to support promotional claims, including for effectiveness and safety while others hold back, uncertain about the possible risks involved.
Where does this RWE business leave drug and device manufacturers?
FDAnews has called on Sonali P. Gunawardhana Esq., one of the sharpest legal minds to emerge from the FDA in recent years and Dr. Mary Jo Lamberti, a faculty member at Tufts CSDD, to shed light.
Mark the calendar for Wednesday, Aug. 15, when Ms. Gunawardhana and Dr. Lamberti show how RWE is transforming FDA’s regulatory approach, from broad policy questions down to the next inspection visit. Attendees will discover:
• Ways drugmakers are using RWE to support promotional claims
• Ways devicemakers are using RWE to support premarket applications
• Why some manufacturers hesitate to use RWE for promotional claims, fearing charges of unsubstantiated claims, increased legal liability, and increased government surveillance
• Impact of recent FDA statements: How the agency may want RWE data included in approval and clearance applications, and as a basis for drug and device promotional claims
• Interpreting FDA guidances: How the agency may use data collected outside of the traditional clinical-trial context to support regulatory decision-making; how RWE “could constitute valid scientific evidence that could be used in some FDA regulatory contexts”
• The 21st Century Cures Act: How it seeks to speed drug and device approval by shifting certain evidentiary requirements from clinical trials to post-market — in other words, to “the real world.”
• And much more!
Every FDA-regulated health science company needs to understand where the agency is heading, identify new opportunities and cut the time and cost of getting approvals and clearances. RWE is here to stay. It’s time I learn what all manufacturers need to know.
Meet the Presenters:
Sonali P. Gunawardhana Esq., Of Counsel, Shook, Hardy & Bacon L.L.P., draws on early 10 years’ experience as an FDA lawyer to offer clients practical, forward-looking guidance on avoiding and resolving FDA regulatory challenges. At the FDA she worked closely with district-office investigators inspecting devicemakers, IRBs, clinical investigators and CROs. Her civilian practice expertise includes current Good Manufacturing Practices (cGMP); clinical trial compliance strategies; and programs that FDA field investigators use during inspections.
Mary Jo Lamberti, PhD, Professor and Associate Director of Sponsored Research at Tufts Center for the Study of Drug Development, leads multi-sponsored and grant funded research projects at the Tufts Center for the Study of Drug Development (CSDD) at Tufts University School of Medicine. She has extensive experience conducting research on pharmaceutical and biotechnology industry practices and trends affecting contract research organizations and investigative sites. She has been a speaker at industry conferences and has published articles in trade and peer-reviewed journals. Prior to joining Tufts, Dr. Lamberti was director of market research at CenterWatch.
Who Will Benefit:
Real world evidence (RWE) affects FDA health regulation across the board – devicemakers, drugmakers, biotech, and consultants to these industries that conduct studies or analyses with RWE. This session will be of particular interest to:
• Regulatory specialists
• Quality specialists
• Strategic planners
• Clinical trial developers
• Data Analysts
Webinar Details:
Getting Real About Real World Evidence:
Practical Next Steps for Drug and Device Manufacturers
**An FDAnews Webinar**
Aug. 15, 2018 — 1:30 p.m. – 2:30 p.m. ET
http://www.fdanews.com/realworldevidence
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/realworldevidence
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
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.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7600, [email protected]
Share this article