PPTX

June 25, 2025

RWD Access and Availability in Patient Safety – Survey Assessment

The intent of this survey is to better understand current utilization and barriers to RWD use among industry stakeholders. Insights from these aggregated and anonymized survey results will raise awareness and help quantify gaps in accessing real-world data (RWD). The survey results potentially provide an opportunity for member companies to draw conclusions about existing gaps…

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June 9, 2025

IGR-Clinical Topic ICH E6 Initiative Overview

An overview of the ICH E6 Topic project and its related solutions & resources.

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June 9, 2025

IGR-Clinical Topic ICH E8 Initiative Overview

An overview of the ICH E8 Topic project and its related solutions & resources.

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May 27, 2025

Operationalizing Platform Trials Initiative Member Informational Session (Presentation)

Presentation material from the “Addressing Unmet Needs in Pediatrics Using Collaborative Platform Trials” member-only initiative spotlight on May 14, 2025.

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January 11, 2024

Interpretation of Pharmacovigilance Guidances & Regulations – Digital Health

This file provides an overview of the Digital Health topic. This team is working to identify key elements of the digital health ecosystem relevant to patient safety and PV to understand the current PV regulatory landscape for digital health in post-marketing settings.

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November 14, 2023

Interpretation of Pharmacovigilance Guidances & Regulations – Completed Topics

This file provides an overview of the first six drug safety topics completed under the IGR-PV initiative.

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August 24, 2023

Interpretation of Pharmacovigilance Guidances & Regulations – Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding

This file provides an overview of the initiative topic, “Regulations Governing the Use of Medicines in Pregnancy & Breastfeeding.” This topic team focused on raising awareness of current regulatory requirements, industry perspective on challenges, and considerations when developing medicinal products for maternal health.

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April 20, 2023

Rapid Signal Assessment Using RWD Current State Survey Assessment Addendum

This survey addendum was conducted to gain additional insight from responding companies of the original survey to understand better whether there might be dependencies between certain practices in rapid RWD analyses for signal assessment regarding the type of analyses performed, type of documentation used, and maximum acceptable timeframes for delivery.

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April 11, 2023

Rapid Signal Assessment Using RWD (RSA-RWD) Initiative Overview

Provides an overview of the Rapid Signal Assessment Using RWD initiative and its solutions.

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March 10, 2023

Participant Data Return Initiative Overview Deck

Provides an overview of the Participant Data Return initiative and its current solutions

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