MAPS speaks with Stefan C. Weiss, MD, Managing Director, Dermatology at OM1 about EMR patient data overlain with technology to create a more accurate and equitable view of post-market safety.
This virtual presentation focuses on 3 aspects of RWE: What are RWE and Real-World Data (RWD), and how are they different? What are relevant legal and regulatory considerations associated with using RWE for product label expansion? How have applicants successfully used RWE to obtain approval for new drug and medical device indications?
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 podcast details ways to identify and engage diverse patients in Medical Affairs clinical trials while empowering the function’s core mission.
This MAPS podcast details potential areas for compliant collaboration by MSLs with Patient Advocacy Groups.
This webinar explores WHAT is IIR vs. Collaborative Research and discusses the challenges of conducting IIR and Collaborative Research.
When quantitative and qualitative Field Medical KPIs and metrics are aligned with the organization’s strategic plan, these measurements demonstrate value. Defining and communicating this value is an essential task as Field Medical solidifies its role as a strategic pillar within the organization.
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.