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FDAnews Announces — Observational Research: Gathering Evidence in the 21st Century Webinar, Sept. 6, 2017

Observational Research:
Gathering Evidence in the 21st Century
**An FDAnews Webinar**
Sept. 6, 2017 — 1:30 p.m. – 3:00 p.m. ET    

The 21st Century Cures Act promises to slash clinical-trial costs and bring drugs to market sooner by letting drugmakers substitute observational data and in house registry data in place of costly new, randomized clinical trial data.

What exactly constitutes ‘significant evidence’? What level of statistical strength are regulators looking for? When is a data point merely an anecdote?

These are but a few of the questions answered in the new FDAnews webinar, Observational Research: Gathering Evidence in the 21st Century.

The guide is researcher-consultant Jeff Trotter, a 30-year veteran of the field. He’ll walk attendees through the cost- and time-saving opportunities that observational studies offer drugmakers and steer them past the pitfalls. Attendees will:

  • Decode the FDA’s fast-evolving views on the health-improvement and cost-saving potential of observational studies and patient registries
  • Dissect patient registries and observational studies to tell what constitutes a good design vs. a poor one
  • Develop a case with regulators and payers via smarter use of effectiveness, safety, HRQoL, satisfaction and resource utilization data
  • Design study teams capable of managing comparative effectiveness research (CER) and health economics and outcomes research (HEOR)
  • And much more!

Cut drug development costs and get new products to market faster! Discover how to take full advantage of the 21st Century Cures Act.

Meet the Presenter:
Jeff Trotter, President, Continuum Clinical

Jeff Trotter has enjoyed a diverse career in the healthcare industry spanning the past 30 years. As an entrepreneur, researcher, consultant, and innovator, Jeff has been a pioneer in the evolving health economics and outcomes research community, and is an industry leader in the design and implementation of research studies generating “real world” evidence. Having engineered the acquisition of his internationally known research and consulting firm, Ovation Research Group, Jeff has been in executive management with other global clinical research organizations, has spoken widely in front of varied industry audiences and has published over 50 original articles and research papers.

Who Will Benefit:

  • Executive management
  • Manufacturing executives
  • Compliance officers
  • R&D
  • Strategic planners/business developers
  • Risk managers
  • Regulatory/legislative affairs
  • Data management/statistics
  • Clinical project specialists
  • Clinical research associates
  • Consultants/service providers
  • General/corporate counsel
  • Study monitors/research coordinators
  • Study sponsors
  • Legal counsel
  • Consultants

Webinar Details:
Observational Research:
Gathering Evidence in the 21st Century
**An FDAnews Webinar**
Sept. 6, 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

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.

Read the full story at

Source: PRWeb
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