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

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

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

This presentation, part 3 of 3, provides insights into the types of communications that the FDA has indicated are or are not permissible, and the uncertainties that still remain.
The Evolving Role of RWE to Support your Medical Strategy

The Evolving Role of RWE to Support your Medical Strategy

In this episode, we hear from RWE and industry experts on the importance of early alignment of your evidence generation plan and medical strategy and how to integrate RWE into your publication plan.
Data-Empowered

Data-Empowered Conference Prep and Planning for MA

In today's episode, we speak with Chris Medieros about how to maximize your organization's presence and impact at congresses.
Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with Data

Demystifying Data in Medical Affairs Part 2: Approaches to Overcome the Issues with 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.
How Companies Are Using Real-World Evidence for Regulatory Purposes

How Companies Are Using Real-World Evidence for Regulatory Purposes

This presentation looks at different regulatory contexts in which product developers are using RWE.

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.
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