Pricing: $405 Member | $505 Non-Member

The RWE Training Program is a comprehensive educational initiative designed to build practical understanding of real‑world evidence and its role in healthcare decision‑making. The program equips payers, pharmaceutical professionals, and other stakeholders with the skills to evaluate, interpret, and apply real‑world evidence using the AMCP RWE Standards as a foundational framework. Through focused instruction on real‑world data sources, study design, evidence quality, and communication of findings, learners gain the ability to assess fit‑for‑purpose evidence and apply payer‑focused standards to support formulary, coverage, and access decisions across the product lifecycle.

Please note, this program is not accredited for continuing pharmacy education.

RWE Essentials Training Program - Provider and Health Plan Version

Training a team? Bulk discounts are available, contact amcplearn@amcp.org for more information.

The RWE Essentials Training Program, developed as part of AMCP's RWE Initiative, is supported by the following 2025 sponsors: Abbvie, AstraZeneca, L.P., Bayer, Boehringer Ingelheim Pharmaceuticals, Inc., Genentech Inc. Gilead Sciences, Inc., IQVIA Inc., Jazz Pharmaceuticals, Johnson & Johnson Health Care Companies, KlearTrust, LEO Pharma, Lilly USA, LLC, Merck & Co., Inc., Pfizer Inc., Sanofi, Takeda Pharmaceuticals America, Inc.

Program Overview

Module 1: Introduction to Real-World Evidence

This introductory module provides a foundational overview of real-world evidence (RWE) and its role in healthcare decision-making. Designed for managed care professionals, the course defines real-world data (RWD) and RWE, explains how RWE is generated, and explores how it complements randomized controlled trials (RCTs) in evaluating therapies across diverse patient populations. 

Learning Objectives:

• Define RWE and its significance in healthcare decision-making.
• Compare and contrast RWE and randomized controlled trials (RCTs).

Module 2: The Value of Real-World Evidence in Managed Care

This module builds on foundational concepts of RWE by examining its practical value within managed care decision-making. Learners will explore how RWE informs managed care decisions, including formulary placement, utilization management, and contracting. Additionally, learners will examine the benefits and limitations of RWE and how it is applied to support evidence-based, value-driven payer strategies.

Learning Objectives:

• Discuss the benefits and limitations of RWE in managed care settings.
• Describe the value of RWE and how it informs payer decisions.

Module 3: Real-World Data Sources

This module introduces the major sources of real-world data (RWD) used in healthcare research and managed care decision-making. Learners will explore common RWD sources, including electronic medical records, claims data, and patient registries, along with their strengths, limitations, and appropriate use cases. The module also introduces the concept of fit-for-purpose data and provides practical guidance on selecting and combining data sources to support credible RWE.

Learning Objectives:

• Recognize key types and sources of real-world data (e.g. claims, EHRs, registries, wearables, etc.)
• Differentiate RWD sources based on their respective strengths and limitations.
• Identify common challenges related to data quality, completeness, and usability.
• Review basic principles to select appropriate data sources for specific research questions.

Module 4: Study Design and Methodologies

This module examines common real-world study designs and methodological considerations used to generate credible RWE. Learners will explore how study design, bias, and confounding affect the reliability of results and how to assess whether evidence is appropriate for coverage, utilization management, and contracting decisions.

Learning Objectives:

• Recognize the major types of real-world study designs (e.g., cohort, case control, cross-sectional) and when each is appropriate for payer decision-making.
• Review practical methods to control for bias and confounding.
• Describe the trade-offs between study rigor and real-world applicability and how they impact coverage, contracting, and clinical program decisions.
• Identify common pifalls in real-world studies that can weaken evidence used for formulary, utilization management, or value-based contracting.

Module 5: RWE Legal, Ethical, and Regulatory Considerations

This module examines the legal, regulatory, and ethical frameworks that govern the generation and use of RWE. Learners will explore key U.S. laws and FDA guidance shaping data use and communication, including privacy protections, pre-approval information exchange, and ethical responsibilities when applying RWE to payer and regulatory decision-making.

Learning Objectives:

• Outline what implementation (or interpretation) of these laws and regulations looks like in RWE and communication.
• Differentiate legal requirements for data collection vs. payer communication.
• Recognize how legal considerations impact both payers and pharmaceutical manufacturers in formulary, contracting, and evidence exchange.

Module 6: AMCP RWE Standards Framework

This module introduces the AMCP Real-World Evidence (RWE) Standards Framework and its role in guiding evidence generation across the product lifecycle. Learners will explore how the framework aligns study types and endpoints to payer decision-making needs and how both payers and manufacturers can apply it to improve evidence planning, study evaluation, and communication.

Learning Objectives:

• Define the purpose of the AMCP RWE Standards and their components.
• Identify the various types of RWE endpoints that could be available and appropriate at the different stages of a product's life cycle.
• Define each criterion element used in study assessments and its significance.
• Discuss how each criterion element impacts study evaluation.

Module 7: AMCP RWE Standards Criteria and Checklist

This module focuses on the AMCP RWE Standards Criteria and Checklist used to evaluate the quality, relevance, and transparency of RWE studies. Learners will examine the purpose and structure of the criteria, explore how they support payer decision-making, and apply the checklist through practical examples to assess and communicate RWE effectively.

Learning Objectives:

• Discuss the purpose and outline of the AMCP Standards Checklist for evaluating quality, relevance, and methodological rigor of RWE studies.
• Describe how the evaluation criteria can be used to support evidence-based decisions in real-world data applications.
• Review examples of how to communicate information about RWE studies using the AMCP RWE Standards checklist.

Module 8: Real-World Evidence in Formulary and Coverage Decisions

This module examines how RWE is applied in payer formulary and coverage decision-making across the drug lifecycle. Learners will explore how RWE fills evidence gaps beyond clinical trials, review real-world payer case examples, and apply the AMCP RWE Framework and Checklist to assess the validity, reliability, and relevance of RWE used to inform coverage, utilization management, and contracting decisions.

Learning Objectives:

• Describe how to access RWE.
• Discuss how RWE complements RCTs in coverage determination and formulary decisions.
• Discuss strategies for incorporating the AMCP RWE Standards into RWE assessment processes for formulary and utilization management, and for contracting opportunities throughout the drug life cycle.
• Review case examples where RWE informed coverage decisions.
• Apply the AMCP RWE Standards to assess and ensure the validity and reliability of all RWE studies.

Module 9: Operationalizing the AMCP RWE Standards for Formulary Impact

This module explores how RWE is used to demonstrate long-term value, support payer engagement, and inform ongoing formulary positioning. Designed for pharmaceutical professionals, learners will explore how the AMCP RWE Standards can be used to design, interpret, and communicate RWE that aligns with payer priorities, builds credibility and transparency, and supports formulary, coverage, and reimbursement decision-making.

Learning Objectives:

• Recognize how RWE supports budget impact models, value-based contracts, and quality performance.
• Identify the types of information that payers prioritize their decision-making processes.
• Discuss strategies to utilize the AMCP Standards to develop strategies that reflect meaningful evidence for payers.
• Review best practices to translate and communicate complex RWE findings into transparent and actionable recommendations for payers.