Evidence Generation Archives - Page 2 of 5 - Medical Affairs Professional Society

Evidence Generation Standards & Guidance and Templates

June 27, 2023/in Integrated Evidence Plan, ACCESS, MAPS Members Only, SEARCH BY TOPIC, Evidence Generation, Evidence Generation, Standards & Guidance and Templates, Content Hub, Featured, Scientific & Technical Knowledge/by Medical Affairs

Evidence Generation Standards Guidance Featured

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Over the last decade as the requirements for evidence to support the various dimensions of value assessment of medicines have strengthened and the breadth of audiences has increased, Medical Affairs is realizing more potential and bringing together its capabilities for strategy, science, and communication in powerful ways. In the rapidly evolving regulatory, technological, and scientific environment, the Medical Affairs function is uniquely positioned to coordinate the identification, prioritization, strategic planning, execution and communication of the broad variety of high-quality evidence necessary to fulfill unmet needs of clinicians, payers, reimbursement agencies, policy makers, advocacy groups, and patients.

This Standard and Guidance is intended to inform learners about the Evidence Generation function, strategic direction, and operations across multiple geographies.

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Executive Vision: The Role of Medical Affairs in Improving Patient Outcomes with Real-World Evidence

June 20, 2023/in ACCESS, Open Access, SEARCH BY TOPIC, SEARCH BY TYPE, Open Access, RWE & HEOR, Evidence Generation, Evidence Generation, Content Hub, White Papers, Content HUB Featured, Interviews & Opinions, Featured, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

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.

Transforming Evidence Generation with Data Visualization: New Approaches for Medical Affairs

June 7, 2023/in ACCESS, Elevate Magazine, SEARCH BY TOPIC, Open Access, Evidence Generation, Innovative Evidence Generation, Digital, Evidence Generation, Content Hub, Content HUB Featured, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

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.

Real-World Evidence: What Can You Say to Payers and Patient Advocates?

March 15, 2023/in ACCESS, MAPS Members Only, SEARCH BY TOPIC, SEARCH BY TYPE, On-Demand Webinars & Town Halls, Privacy & Patient (Organizations) Interactions, Evidence Generation, Medical Governance & Compliance, Content Hub/by MGluckle@MedicalAffairs.org

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Medical Affairs professionals want to share Real-World Evidence (RWE) about drug products with payers, patient advocates and others, but communications about drug products are highly regulated. Federal laws, including FDAMA Section 114, FDA guidance materials and FDA enforcement actions all provide insight into the types of communications FDA will and will not accept. This presentation will provide insights into the types of communications that FDA has indicated are or are not permissible, and the uncertainties that still remain.

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Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

March 1, 2023/in ACCESS, MAPS Members Only, SEARCH BY TOPIC, SEARCH BY TYPE, Evidence Generation, Innovative Evidence Generation, On-Demand Webinars & Town Halls, Evidence Generation, Content Hub, Insights Process/by MGluckle@MedicalAffairs.org

Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

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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:

Real world examples of impactful use of data by MA teams
How to anonymize data
How to encourage data vendors to provide data you use
How to work with government and healthcare authorities on data

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.

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How Companies Are Using Real-World Evidence for Regulatory Purposes

January 18, 2023/in ACCESS, MAPS Members Only, SEARCH BY TOPIC, RWE & HEOR, SEARCH BY TYPE, Evidence Generation, On-Demand Webinars & Town Halls, Evidence Generation, Content Hub, Foundational (Intro Level)/by MGluckle@MedicalAffairs.org

How Companies Are Using Real-World Evidence for Regulatory Purposes

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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.

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Using Real-World Evidence for Label Expansions

November 16, 2022/in ACCESS, MAPS Members Only, Competency, SEARCH BY TOPIC, RWE & HEOR, SEARCH BY TYPE, Evidence Generation, On-Demand Webinars & Town Halls, Evidence Generation, Content Hub/by MGluckle@MedicalAffairs.org

Using Real-World Evidence for Label Expansions

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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?

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How Can Real-World Evidence Help Medical Affairs Professionals?

March 17, 2022/in Competency, ACCESS, RWE & HEOR, Open Access, Evidence Generation, Evidence Generation, Content Hub, White Papers, Content HUB Featured, SEARCH BY TOPIC, SEARCH BY TYPE/by 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.

Real World Evidence Applications and How it Can Change Medicine and Biopharma

February 7, 2022/in Competency, ACCESS, RWE & HEOR, Open Access, Evidence Generation, Evidence Generation, Podcasts, Content Hub, Insights Process, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

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.

Expert Opinions on the Collection and Use of Real-World Evidence (RWE) in China and Korea

January 18, 2022/in ACCESS, Competency, Elevate Magazine, RWE & HEOR, Open Access, Evidence Generation, Evidence Generation, Content Hub, Content HUB Featured, Interviews & Opinions, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

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.

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