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A Whole New World: Real World Evidence (RWE)
Session Chair(s)
Donna Booth, PharmD
Head, Field Medical Accounts-East, US Medical Affairs
GlaxoSmithKline, United States
RWE plays an increasing role in healthcare decisions. Medical Information Departments vary in their understanding and approach to the dissemination for RWE based on guidance documents issued by FDA. As the US healthcare system continues to seek value for patients, it is increasingly important to have strategies for incorporating RWE into materials provided across the continuum of decision-makers (Regulators, Payers, Providers, and Patients). *Note: Audience participation will enhance the learning experience from this session.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Recognize the importance of RWE to the decision-making process
- Discuss the FDA guidance documents that regulate the dissemination of RWE
- Propose strategies for dissemination of RWE by sharing examples utilized by various Medical Information Departments that demonstrated success as well as areas for improvement
Speaker(s)
Collaborative Discussion on the Use of RWE based on Recent FDA Guidance
Donna Booth, PharmD
GlaxoSmithKline, United States
Head, Field Medical Accounts-East, US Medical Affairs
Collaborative Discussion on the Use of RWE based on Recent FDA Guidance
Ellen Whipple, PharmD
EW Associates, LLC, United States
Owner/Principal Writer