25oct12:30 pmApplying Real-World Evidence to Regulatory and Drug Development ChallengesHarvard Medical School Online Webinar Hosted by: Harvard Medical School Executive Education

Hosted by

Harvard Medical School Executive Education

Event Details

In response to patient needs, technological advances, regulatory mandates, and drug-development pressures, the role of Real-World Evidence (RWE) is rapidly evolving in the United States and around the globe. Real World Data (RWD) about patient outcomes may be particularly important when randomized controlled trials are infeasible, impractical, or unethical for specific populations. Multiple stakeholders (regulators, life-science companies, payers, patient advocates, academics, data vendors, health care systems, etc.) are investing to curate rich RWD sources and develop robust RWE methods.

Dr. Rebecca Miksad, Senior Medical Director, Flatiron Health, will discuss a recent oncology use case of Electronic Health record (EHR)-derived RWE in the regulatory context. She will also recommend key considerations for the effective application of RWE approaches. In addition, Dr. Miksad will explore the future landscape of RWE in late clinical drug development.

Through examples and discussion, this webinar will help life science business leaders and regulators to assess the value (and challenges) of RWE to drive better decisions and better patient care.

Time

Oct. 25, 12:30-1 p.m.

Location

Harvard Medical School Online Webinar

4 Blackfan Circle

Boston, MA 02115

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