In this on-demand webinar, learn how to shift the paradigm on integrated evidence generation.
This article highlights a collaborative approach to content creation in which insights from MSLs were used to develop concepts for educational tools that were shared with key opinion leaders (KOLs).
This Standard and Guidance is intended to inform learners about the Evidence Generation function, strategic direction, and operations across multiple geographies.
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.