The growth of Real-World Evidence (RWE) from sources including patient registries, claims data, electronic medical records, digital health technologies and more has powered the ability of Medical Affairs to drive patient outcomes. Here, the MAPS Executive Consortium describes how.
As evidence generation becomes more advanced and integrated into Medical Affairs strategic plans, there is a greater need to maximize its impact by leveraging emerging digital technologies to communicate complex clinical and nonclinical data.
This presentation, part 3 of 3, provides insights into the types of communications that the FDA has indicated are or are not permissible, and the uncertainties that still remain.
This Webinar series explores the fundamental concept of big data in Medical Affairs, from which sources can we retrieve this, what are the broader considerations when utilizing data in health and what impact this can have on our organizations, physicians, and patients, now and in the future.
This presentation looks at different regulatory contexts in which product developers are using RWE.
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 MAPS podcast details potential areas for compliant collaboration by MSLs with Patient Advocacy Groups.