Is the FDA's New Guidance a Watershed Moment for Real-world Evidence?

May 1, 2019
11:00AM EDT | 4:00PM GMT | 5:00PM CET- 1 hour in duration
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Speakers: Elenee Argentinis, Kristen K. Buck, MD, Martha Bayliss, John Seeger, PharmD, DrPH

On December 6, 2018, the FDA announced the development of a new strategic framework to advance the use of real-world evidence (RWE) for drugs and biologics. It defines RWE as being derived from a diverse array of sources such as: electronic health records, medical claims, laboratory test results, and more. This development has wide-ranging consequences for the industry.

In this hour-long webinar learn how this new guidance may impact your:

  • data acquisition approach;
  • clinical trial operations;
  • HEOR and Epidemiology methods; and
  • Patient-reported outcome strategy.

This webinar is complimentary for members and non-members.
If you would like to participate in this webinar,
be sure to register via the link provided below!

Register Here


This webinar is brought to you by:



Elenee Argentinis
Vice President
Data Strategy and Partnerships, Optum

Kristen K. Buck, MD
Senior Vice President
Chief Clinical Development, Optum

Martha Bayliss
Vice President
Patient Insights and Principal Scientist, Optum

John Seeger, PharmD, DrPH
Chief Scientific Officer
Epidemiology, Optum

Please note: On the day of the scheduled webinar, the first 500 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 weeks after the scheduled Webinar.

Reservations are on a first-come, first-served basis for all ISPOR members.

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