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.
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?
At the MAPS 2022 Global Annual Meeting, we sat down with Riad Dirani and Omar Dabbous to chat about the structure and activities of HEOR within Medical Affairs.
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.
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.
This MAPS webinar details HEOR professional competencies included in the ISPOR Competency Framework, defining which are most relevant to Medical Affairs professionals.