Impact of the 21st Century Cures Act
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.
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.
MAPS speaks with co-leads of the Insights Focus Area Working Group (FAWG) about the current state and future directions for Insights in Medical Affairs.
This 8th episode in our Field Medical podcast series explores the evolving roles of MSLs in the context of clinical trials.
Events of the last 12 months have driven the pharmaceutical industry to more comprehensively examine how it can address ethnic and racial disparities in health outcomes and clinical research access. It is well accepted that diversity of clinical trial participants is essential to ensure that the trial population is truly representative of the patients who will use the therapy, yet disparities in clinical trial participation remain. A multi-faceted approach is required to understand the critical barriers to clinical research access for patients from diverse backgrounds.
During this thought-provoking webinar, our panel of internationally renowned Patient Advisors and Diversity Experts will share their perspectives on diverse representation in clinical trials and key barriers to research access, and explore solutions to address these critical issues.
This program will:
• Define health economics and outcomes research (HEOR) and its relationship to Medical Affairs
• Understand HEOR professional competencies included in the ISPOR Competency Framework, and which are most relevant to Medical Affairs professionals
• Discuss potential applications of the competencies by different stakeholders (employers, new professionals, students, academia)
• Identify ways for Medical Affairs professionals to further their HEOR knowledge and skills
In this edition of Perspectives, MAPS Americas Region President, Dr John Pracyk speaks with J&J leaders about the keys to success in Medical Affairs.
The importance of medical insights is well recognized across the pharmaceutical industry as a key driver for informing and shaping strategy and tactics. To gain a better understanding of this pivotal Medical Affairs activity, the Medical Affairs Professional Society (MAPS) conducted two membership surveys specifically addressing insights. The surveys highlighted a wide variation in how companies approach medical insights, without any obvious areas of best practice or common frameworks in use despite the current recognition of the importance and relevance of medical insights. The survey results indicate the need to identify a common framework across Medical Affairs for insight-related activities (i.e., insights or information generation, curation, collation, reporting, and utilization). Establishing such a framework is necessary to optimize medical insights’ impact and value in a broader organizational strategy.
This paper explores how moving from a fragmented approach focused on individual Medical Affairs channels (e.g., MSLs or Medical Information) to a more holistic, multi-channel, integrated approach to insights will create value for the organization, as well as for patients and the medical and scientific community.
This podcast offers insights surrounding common challenges Medical Affairs organizations face in offering best-in-class digital capabilities.
This session will provide a learning opportunity for our audience by describing:
• An evolved Medical Communications function, by articulating the critical capabilities that make it a driver of strategic scientific communications aligned with overall medical imperatives
• A “Supernova” MA Therapeutic Area (strategy) and Medical Communications Team: An empowered Medical Communications department is a strategic partner to Therapeutic Area teams and exponentially increasing the value of MA deliverables
• The rationale and approach for developing a strategic Medical Communications Strategy and its components
At the end of this series of podcasts, the participant should be able to identify potential areas for compliant collaboration by MSLs with key internal partners.
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