EVIDENCE GENERATION

FOCUS AREA WORKING GROUP

The mission of the Evidence Generation Focus Area Working Group (FAWG) is to educate the MAPS membership on contemporary practices for data generation strategies, including the design, implementation, and communication of new evidence, and educate the MAPs membership how real-world (RW) evidence may be utilized to support product value; including labeling changes.

Activities: 

To reach our goals, the Evidence Generation FAWG will execute on two key objectives. First, through educational programs and communications, we will increase understanding of requirements for Evidence Generation in the context of Medical Affairs strategic planning & execution of evidence generation plans. Second, we will explore applications of real-world evidence across stakeholders within Medical Affairs, with the purpose of increasing the acceptance of real-world evidence for regulatory purposes.

As part of this plan, we will organize a host of Evidence Generation activities including workshops for MAPS meetings in the North America, with longer term plans and aspirations of conducting Evidence Generation workshops in APAC (Asia Pacific – China/Japan), and EMEA (Europe, Middle East, Asia) regions.

We will develop original content for webinars, podcasts, eLearning courses, and white papers. In addition, the working group will periodically contribute cogent and timely content on the Evidence Generation sector for the MAPS publication, Elevate magazine. Most importantly, we will provide a supportive resource for all Medical Affairs professionals seeking advice and direction on data generation and regulatory strategies.

Strategic Objectives

  1. Enhance foundational knowledge, standards and technical skills for evidence generation:
    • Develop understanding of standards and guidance for evidence generation.
    • Support planning & execution of evidence generation strategy in Medical Affairs.
  2. Increase opportunities for evidence generation:
    • Explore applications of real-world evidence across Regions.
    • Increase transparency and acceptance of real-world evidence.

LATEST PODCAST EPISODE

Description: MAPS speaks with Kent Summers, HEOR Lead at AlphaGroup and Steve Camper, VP of Medical Affairs at Blue Earth Diagnostics, about building Health Economics and Outcomes Research capabilities within Medical Affairs.

FAWG OVERVIEW

MEMBERS

RESOURCES RELATED TO EVIDENCE GENERATION

Using Real-World Data to Understand Patient Journeys in Dermatology

MAPS speaks with Stefan C. Weiss, MD, Managing Director, Dermatology at OM1 about EMR patient data overlain with technology to create a more accurate and equitable view of post-market safety.
Using Real-World Evidence for Label Expansions

Using Real-World Evidence for Label Expansions

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?
RWE Help MA Featured

How Can Real-World Evidence Help Medical Affairs Professionals?

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

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

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

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.
Medical Affairs Opportunities of Real World Evidence

The Medical Affairs Opportunities of Real World Evidence

This podcast details ways to identify and engage diverse patients in Medical Affairs clinical trials while empowering the function’s core mission.
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