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FDAnews Announces — Observational Studies: New Frontiers in Gathering Evidence Webinar, Dec. 2, 2015
  • USA - English


News provided by

FDANEWS

Nov 13, 2015, 14:00 ET

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FDAnews
FDAnews

Falls Church, VA (PRWEB) November 13, 2015 -- Observational Studies:
New Frontiers in Gathering Evidence
Dec. 2, 2015 — 10:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/observationalstudies

Whether a company markets drugs or devices, they must demonstrate convincingly that their products are safe and effective in the real world.

Observational studies are increasingly critical in compiling and communicating evidence of clinical, economic, and humanistic value.

Will the observational studies created deliver persuasive data? Does the company have the skill set to construct persuasive and scientifically sound patient registries?

Manufacturers need to know:
• What constitutes reasonable and compelling evidence
• What stakeholders are demanding real world evidence
• How to cost-efficiently run an observational study

Mark the calendar for Dec. 2, 2015 when Jeff Trotter, president of Continuum Clinical, walks attendees through the opportunities and pitfalls of observational studies. He will cover:
• Key findings from Continuum’s 9th Survey on Observational Research
• The critical link between strategy and operational efficiency in observational studies
• Setting internal and external expectations for real world evidence
• Best practices for ensuring clinical and commercial collaboration in support of observational studies and patient registries

Register today and develop critical evidence faster by using observational studies.

Who Will Benefit:
• Clinical project specialists
• Clinical research associates
• Compliance officers
• Consultants/service providers
• Data management and statistics personnel
• Executive management
• General/corporate counsel
• Investigators
• Managers
• Manufacturing directors and supervisors
• R&D staff
• Regulatory/legislative affairs professionals
• Risk management specialists
• Strategic planning and business development staff
• Study monitors
• Study research coordinators
• Study sponsors

Meet the Instructor:
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 — including a book for the American Hospital Association, The Quest for Cost-Effectiveness in Healthcare: Achieving Clinical Excellence While Controlling Cost and is currently co-editing another book on observational research.

Webinar Details:
Observational Studies:
New Frontiers in Gathering Evidence
Dec. 2, 2015 — 10:00 a.m. – 12:30 p.m. EST
http://www.fdanews.com/observationalstudies

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/observationalstudies
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) 538-7665, [email protected]

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