How the Use of non-Registrational Evidence by Medical Affairs Improves Patient Outcomes
This paper discusses the sources and uses of non-registrational evidence and describes why Medical Affairs is positioned to lead and own the nRE Strategic Plan.
Health Disparities 1: FDA Efforts to Advance Women and Minorities in Clinical Trials
This session provides a learning opportunity for our audience by providing background on FDA’s Offices of Minority Health and Health Equity, and Women’s Health
Impact of the 21st Century Cures Act
The objective of this podcast is to discuss how the 21st Century Cures Act has led to new initiatives at FDA involving Real World Evidence.
Diverse Representation in Clinical Research: Sharing Patient and Physician Perspectives
Patient Advisors and Diversity Experts share their perspectives on diverse representation in clinical trials and key barriers to research access, and explore solutions to address these critical issues.
Standards & Guidance: RWE & HEOR
This Powerpoint offers a comprehensive overview of Real World Evidence (RWE) and its evolving use in the biopharmaceutical industry.
Creating an HEOR Function Within Medical Affairs
MAPS explores Health Economics and Outcomes Research (HEOR): Why a Medical Affairs organization needs an HEOR function and how to build this capability.
History of Real-World Evidence Prior to the 21st Century Cures Act
Medical Affairs thought leaders discuss the Pre-21st Century Cures Act uses of Real World Evidence (RWE) in regulatory decision-making.
The Application of Real-World Evidence in Regulatory Decision Making
Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.
Contemporary Applications of Real-World Evidence in Regulatory Decision Making: A Case Series Review
Real-World Evidence can show safety and effectiveness per FDA’s “totality of evidence approach” for evaluating regulatory submissions.
Now More Than Ever, HEOR Plays a Central Role in Forging the Modern Healthcare Agenda
Examine the current state & future of HEOR data in healthcare decision-making; discuss strategies to build strong relationships with payers, the medical community, and patient advocacy groups; determine the impact and value of evidence-based pricing and payment