How Can Real-World Evidence Help Medical Affairs Professionals?
This white paper provides Medical Affairs professionals with the background and history of Real-World Evidence, and its applications in the biopharma industry to benefit patients.
Real World Evidence Applications and How it Can Change Medicine and Biopharma
This podcast focuses on applications of Real World Evidence including FDA criteria for accepting RWE, types of data, RWE study designs and the Totality of Evidence approach.
Expert Opinions on the Collection and Use of Real-World Evidence (RWE) in China and Korea
There is growing interest globally in using real-world data (RWD) and real-world evidence (RWE) for applications including regulatory decisions, health technology assessment (HTA), pharmacovigilance and more. However, Asia currently lacks a framework to effectively collect and utilize a broad range of RWD/RWE.
How to Engage External Research (IIR and Collaborative Research) – Practical Compliance Considerations
This webinar explores WHAT is IIR vs. Collaborative Research and discusses the challenges of conducting IIR and Collaborative Research.
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.