Explore, Educate, Embrace: Opportunities for Medical Affairs to Impact Health Disparities & Inequities
By using the framework of Explore, Educate, Embrace we can shape our approach to Health Equity by incorporating it into our daily work.
By using the framework of Explore, Educate, Embrace we can shape our approach to Health Equity by incorporating it into our daily work.
All industries are rushing to harness rich data in order to drive progress, but how can the many data sources help Medical Affairs to show impact and drive improved patient outcomes?
In part two of this four part series, we will discuss:
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.
Product Developers are using Real-World Evidence (RWE) for regulatory purposes in an expanding range of contexts. Drug sponsors are directly using RWE as an external control arm in clinical trials. Companies also use RWE to obtain label expansions and to satisfy post-market approval requirements. RWE is also being used to help design traditional clinical studies, to help select clinical trial sites and identify study endpoints. This presentation looks at different regulatory contexts in which product developers are using RWE.
It is hard to overstate the expansion of Real-World Evidence (RWE) over the last 5 years. ISPOR has designated RWE the #1 trend in Health Economics for 2022-2023. Most new drug and biologics applications to FDA now include RWE information.
The use of RWE to support product label expansion has been a primary driver of interest in RWE. The 21st Century America Cures Act, enacted in 2016, required FDA to evaluate RWE in support of new drug indications. Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications. The Agency has also utilized RWE in approving expanded indications for drug products. As FDA states at the top of its RWE web page, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”
This virtual presentation will focus on 3 aspects of RWE:
1) What are RWE and Real-World Data (RWD), and how are they different?
2) What are relevant legal and regulatory considerations associated with using RWE for product label expansion?
3) 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.
By the end of this series, we hope you will gain:
At the MAPS 2022 Global Annual Meeting, we sat down with Riad Dirani, Vice President of Global Health Economics and Outcomes Research at Teva Pharmaceuticals, and Omar Dabbous, Vice President of Global Health Economics and Outcomes Research and Real World Evidence at AveXis 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.
602 Park Point Drive, Suite 225, Golden, CO 80401 – +1 303.495.2073
© 2024 Medical Affairs Professional Society (MAPS). All Rights Reserved Worldwide.