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Applying Real-World Evidence to Regulatory and Drug Development Challenges

Harvard Medical School Online Webinar

10/25/2019

12:30pm - 1:00pm

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.

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Contact: Tess MacCurdy
Contact Phone: 6174323560
Contact Email: tess_maccurdy@hms.harvard.edu