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 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. These presentations will feature real world cases that are relevant to regional and country Medical Affairs leaders, in order to highlight long-term aspirational and short-term tangible projects.
In this webinar, we’ll discover an evolving framework that leverages various perspectives within our industry to address health disparities & inequities in order to bring a more equitable distribution of healthcare.
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.
This webinar explores WHAT is IIR vs. Collaborative Research and discusses the challenges of conducting IIR and Collaborative Research.
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.