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Health Disparities 1: FDA Efforts to Advance Women and Minorities in Clinical Trials

August 11, 2021/in Competency, SEARCH BY TYPE, Evidence Generation, Webinars, Health Equity/by Medical Affairs

This session provides a learning opportunity for our audience by providing background on FDA’s Offices of Minority Health and Health Equity, and Women’s Health

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https://medicalaffairs.org/wp-content/uploads/2021/08/August11-webinar.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2021-08-11 01:37:422025-07-08 14:20:47Health Disparities 1: FDA Efforts to Advance Women and Minorities in Clinical Trials

Impact of the 21st Century Cures Act

March 29, 2021/in Competency, SEARCH BY TYPE, RWE & HEOR, Evidence Generation, Elevate Podcasts/by Medical Affairs

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.

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https://medicalaffairs.org/wp-content/uploads/2021/03/Impact-of-the-21st-Century-Cures-Act.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2021-03-29 08:25:062025-07-11 16:08:05Impact of the 21st Century Cures Act

Diverse Representation in Clinical Research: Sharing Patient and Physician Perspectives

March 19, 2021/in Competency, SEARCH BY TYPE, Evidence Generation, Webinars, Health Equity/by Medical Affairs

Patient Advisors and Diversity Experts share their perspectives on diverse representation in clinical trials and key barriers to research access, and explore solutions to address these critical issues.

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https://medicalaffairs.org/wp-content/uploads/2021/03/March19-pcmwebinar-1.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2021-03-19 11:06:132025-07-29 14:31:42Diverse Representation in Clinical Research: Sharing Patient and Physician Perspectives

Standards & Guidance: RWE & HEOR

January 12, 2021/in Standards & Guidance, Competency, SEARCH BY TYPE, RWE & HEOR, Evidence Generation/by Medical Affairs

This Powerpoint offers a comprehensive overview of Real World Evidence (RWE) and its evolving use in the biopharmaceutical industry.

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https://medicalaffairs.org/wp-content/uploads/2021/01/evidencegen-rwe-heor.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2021-01-12 14:51:512025-07-23 14:46:27Standards & Guidance: RWE & HEOR

Creating an HEOR Function Within Medical Affairs

January 11, 2021/in Competency, RWE & HEOR, SEARCH BY TYPE, Evidence Generation, Elevate Podcasts/by Medical Affairs

MAPS explores Health Economics and Outcomes Research (HEOR): Why a Medical Affairs organization needs an HEOR function and how to build this capability.

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https://medicalaffairs.org/wp-content/uploads/2021/01/podcasts-alpha-group-Best-Practices.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2021-01-11 08:08:542025-07-09 14:58:55Creating an HEOR Function Within Medical Affairs

History of Real-World Evidence Prior to the 21st Century Cures Act

November 16, 2020/in Competency, SEARCH BY TYPE, RWE & HEOR, Evidence Generation, Elevate Podcasts/by Medical Affairs

Medical Affairs thought leaders discuss the Pre-21st Century Cures Act uses of Real World Evidence (RWE) in regulatory decision-making.

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https://medicalaffairs.org/wp-content/uploads/2020/11/History-Century-Cures-Act.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2020-11-16 10:44:302025-07-11 17:12:13History of Real-World Evidence Prior to the 21st Century Cures Act

The Application of Real-World Evidence in Regulatory Decision Making

October 20, 2020/in Competency, SEARCH BY TYPE, RWE & HEOR, Evidence Generation, Elevate Podcasts/by Medical Affairs

Cerise James, MD, moderates this podcast in which Neil Belson, JD, discusses Real World Evidence and its impact to the biopharmaceutical industry.

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https://medicalaffairs.org/wp-content/uploads/2020/10/Application-of-RWE.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2020-10-20 12:11:442025-07-11 17:24:43The Application of Real-World Evidence in Regulatory Decision Making

Contemporary Applications of Real-World Evidence in Regulatory Decision Making: A Case Series Review

October 20, 2020/in Competency, RWE & HEOR, SEARCH BY TYPE, Evidence Generation, Elevate Articles, Content HUB Featured, SEARCH BY TOPIC, SEARCH BY TYPE/by Medical Affairs

Real-World Evidence can show safety and effectiveness per FDA’s “totality of evidence approach” for evaluating regulatory submissions.

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https://medicalaffairs.org/wp-content/uploads/2020/10/Contemporary-Applications-of-Real-World-Evidence-in-Regulatory-Decision-Making-A-Case-Series-Review.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2020-10-20 10:32:152025-08-08 13:16:42Contemporary Applications of Real-World Evidence in Regulatory Decision Making: A Case Series Review

Now More Than Ever, HEOR Plays a Central Role in Forging the Modern Healthcare Agenda

June 24, 2018/in Competency, RWE & HEOR, SEARCH BY TYPE, Evidence Generation, Webinars/by Medical Affairs

Examine the current state & future of HEOR data in healthcare decision-making; discuss strategies to build strong relationships with payers, the medical community, and patient advocacy groups; determine the impact and value of evidence-based pricing and payment

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https://medicalaffairs.org/wp-content/uploads/2018/06/june-24-webinar.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2018-06-24 10:51:132025-07-03 08:50:57Now More Than Ever, HEOR Plays a Central Role in Forging the Modern Healthcare Agenda

Best Practices for Managing the Life Cycle of an Investigator-Initiated Research (IIR)

May 4, 2018/in Competency, SEARCH BY TYPE, Evidence Generation, Non-Company Sponsored Research, Webinars/by Medical Affairs

This Webinar will discuss the process of investigator initiated research program followed across industry. The process is initiated externally by submission of IIR application via company website followed by internal company review and decision making process. This results in the execution of IIR study contract between the company and the Institution after which the study is initiated by the Investigator.

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https://medicalaffairs.org/wp-content/uploads/2018/05/May4-pcmwebinar.png 642 1690 Medical Affairs https://medicalaffairs.org/wp-content/uploads/2025/03/MAPS-Logo-R-NoTagLine-2048x679-1.png Medical Affairs2018-05-04 10:44:112025-07-29 14:36:27Best Practices for Managing the Life Cycle of an Investigator-Initiated Research (IIR)
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