Real-World Evidence in Clinical Trials:  Are You Prepared for the Practical Effect of RWE’s Explosion?

A CenterWatch Webinar

Real-World Evidence in Clinical Trials: Are You Prepared for the Practical Effect of RWE’s Explosion?

MARCH
1

Due to unforeseen circumstances this webinar has been postponed until Thursday, March 1, 2018, 11:00 a.m. – 12:30 p.m. ET

When it comes to clinical trials, you know you’re dealing with the real world. But now, the federal government and the industry itself is expecting you to not only know about your own trials, but with Real-World Data (RWD) and Real-World Evidence (RWE) relating, in virtually any way, to those trials.

In seemingly the blink of an eye, you’re fully expected to be on board with furnishing RWE to both FDA regulatory authorities and to follow best industry practices on RWD and RWE, which affects all professionals who administer clinical trials as well as regulatory and quality specialists.

Are you really prepared for this explosion in data as the FDA and other government agencies increasingly rely on real-world evidence, both in the development of medical products — from large simple trials to pragmatic clinical trials to observations studies — and then also in postmarket safety?

Drug and device manufacturers — in fact, the entire healthcare community — are using RWD and RWE to support their clinical trials data. Are you? And are you up-to-speed on the requirements of the 21st Century Cures Act, which are placing an additional focus on the use of these types of data to support regulatory decision making.

You need the latest information and guidance on RWE — Now! But don’t fret. All you need to do is put this date on your calendar — Thursday, March 1, 2018. That’s the date of the most important webinar on RWE you’ll attend this year. In just 90 minutes you’ll hear two seasoned professionals on RWE and RWD describe what’s really happening on these critical clinical trials issues:

  • The FDA’s use of RWD and RWE to monitor postmarket safety and adverse events involving medical products.
  • The healthcare community’s burgeoning utilization of RWD to support coverage decisions and to develop guidelines and decision support tools for use in clinical practice.
  • The best practices for integrating RWD and RWE into the different phases of clinical trials to produce more statistically valid and data-based trials.
  • The use of RWD and RWE by medical product developers, including existing and potential competitors, to support clinical trial designs involving large, simple trials, pragmatic clinical trials and observational studies to generate innovative, new treatment approaches.
  • The evolving implementation of the 21st Century Cures Act, which places additional focus on data to support regulatory and quality decision making.

Your presenters, Richard Young and Ken Getz are rock stars (without rock star egos) in this expanding space. They’ll provide the insightful information to stay ahead of the FDA and other governmental requirements for RWE and RWD — and your competitors as well.

Do not get caught short when federal regulators review you clinical trials submssions or closely inspect your postmarket surveillance program. Take advantage of this timely presentation to learn the nuances of RWE and RWD, and the tips you can put into place to establish best practices.

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Webinar ONLY
Price: $287.00
Webinar PLUS Audio Flash Drive and Transcript
Price: $487.00

Who Will Benefit?

This session is appropriate for any organization in the clinical trials space and individuals holding these job titles:

  • Regulatory and compliance specialist
  • Data metrics and data management directors
  • IRB member or staffer
  • Principal investigator
  • Study coordinator
  • Clinical researcher or associate
  • Clinical recruiter
  • Risk manager
  • General or outside counsel
  • Institutional official
  • Medical affairs director