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.
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.
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.
This session will provide a learning opportunity for our audience by:
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.
In this episode of Partnering for Today and Tomorrow we discuss the functions and activities of key internal partners and how we identify potential areas for compliant collaboration by MSLs with key internal partners.
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.
Events of the last 12 months have driven the pharmaceutical industry to more comprehensively examine how it can address ethnic and racial disparities in health outcomes and clinical research access. It is well accepted that diversity of clinical trial participants is essential to ensure that the trial population is truly representative of the patients who will use the therapy, yet disparities in clinical trial participation remain. A multi-faceted approach is required to understand the critical barriers to clinical research access for patients from diverse backgrounds.
During this thought-provoking webinar, our panel of internationally renowned Patient Advisors and Diversity Experts will share their perspectives on diverse representation in clinical trials and key barriers to research access, and explore solutions to address these critical issues.
This program will:
• Define health economics and outcomes research (HEOR) and its relationship to Medical Affairs
• Understand HEOR professional competencies included in the ISPOR Competency Framework, and which are most relevant to Medical Affairs professionals
• Discuss potential applications of the competencies by different stakeholders (employers, new professionals, students, academia)
• Identify ways for Medical Affairs professionals to further their HEOR knowledge and skills
This Powerpoint by the MAPS Evidence Generation Focus Area Working Group offers a comprehensive overview of Real World Evidence (RWE) and its evolving use in the biopharmaceutical industry.