FDAnews Announces — FDA’s NEST Program and Real World Evidence: Evaluating Benefit & Risk: What Devicemakers Need to Know Webinar, July 17, 2018
FALLS CHURCH, Va. (PRWEB) July 10, 2018 -- “Better, faster, cheaper.” That’s why the FDA is developing the National Evaluation System for Health Technology (NEST). It will generate better evidence for medical device evaluation and regulatory decision-making, streamlining today’s time-consuming, costly device evaluation system.
“Getting new products to market faster.” That’s what devicemakers are about. And NEST is expected to help.
Mark the calendar for Tuesday, July 17, when FDAnews connects attendees with one of the agency’s chief NEST builders for a look inside the system he’s building.
Gregory Pappas MD Ph.D. is Associate Director for NEST at CDRH, FDA. Over the course of a fast-paced 90 minutes, he’ll bring attendees up to speed on NEST’s current status and what it can do:
• Real World Evidence (RWE): Why the FDA is promoting it to evaluate medical devices
• How to comply with NEST goals
• Proof of concept as it applies to using RWE for device evaluation
• Best practices and success stories
• Specific medical devices: How RWE and NEST can specifically apply to their development
• And much more!
Device evaluation currently used by the FDA is badly in need of improvement, many agree. NEST is seen as a real opportunity to find “better, faster, cheaper” approaches to evidence-based generation for device evaluation and get new products to market in less time.
Meet the Presenter:
Gregory Pappas M.D. Ph.D. is Associate Director for NEST National Device Evaluation at CDRH, FDA. He works with stakeholders including government agencies, industry, health care providers, patient groups and data partners to develop the use of real world evidence. He previously served as the Senior Deputy Director of HAHSTA (HIV/AIDS, Hepatitis, STD, and TB Administration) for the District of Columbia Department of Health. He has worked professionally in over 30 countries. His consultancies include work with WHO, USAID, World Bank, and CDC.
Who Will Benefit:
Devicemakers will benefit from this presentation in general. Job titles include but are not limited to:
• Regulatory/compliance
• Quality assurance
• Manufacturing/GMP/cGMP
• Supply chain executives
• Auditors
• Legal counsel
Webinar Details:
FDA’s NEST Program and Real World Evidence:
Evaluating Benefit & Risk: What Devicemakers Need to Know
**An FDAnews Webinar**
July 17, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/nestprogramrwe
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/nestprogramrwe
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, +1 703-538-7660, [email protected]
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