FDA’s NEST Program and Real World Evidence
Evaluating Benefit & Risk: What Devicemakers Need to Know

Tuesday, July 17, 2018 · 1:30 p.m. - 3:00 p.m. EDT

The FDA is working on simplifying the evaluation of new medical devices via Real World Evidence (RWE). The FDA initiative is known as NEST (National Evaluation System for Health Technology) … and it could benefit you.

Mark your calendar for Tuesday, July 17, when one of the agency’s chief NEST builders takes you inside the system he’s building for a look around.

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 you up to speed on NEST’s current status and what it can do for you:

  • 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
  • Your 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 your new products to market in less time.

Register now.

BONUS: Order the webinar plus audio recording/transcript or the 24/7 encore plus audio recording/transcript for $487, and receive a FREE copy of The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium (retail value $397).

The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium
The report walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. It looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products.


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 plus Audio Recording/Transcript with BONUS
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$487

add to cart

Webinar only
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$287

add to cart

24/7 Encore plus Audio Recording/Transcript with BONUS
Learn more

$487

add to cart

24/7 Encore Presentation
Learn more

$287

add to cart

Audio Recording/Transcript
Learn more

$287

add to cart

 

 

 

Meet Your Presenter

Gregory Pappas M.D. Ph.D.

Associate Director for NEST National Device Evaluation
CDRH, FDA

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.

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