August 24, 2023
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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June 8, 2023
The Safety Data Exchange Timelines for Individual Case Safety Reports (ICSR) & Aggregate Reports Benchmarking Survey Data Summary is an aggregate benchmarking of safety exchange timelines in member companies’ PVAs. The Summary provides a transparent resource for companies on the timelines used in PVAs for medium to large pharmaceutical companies.
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April 20, 2023
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
Provides an overview of the Rapid Signal Assessment Using RWD initiative and its solutions.
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March 10, 2023
Provides an overview of the Participant Data Return initiative and its current solutions
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February 24, 2023
This webinar shares the outcomes of a current state assessment conducted by the TransCelerate Initiative, "Rapid Use of RWD for Signal Assessment" (RSA-RWD). The current state assessment included both a Member Company survey and literature review. In addition to focusing on where rapid use of RWD for safety signal assessment is currently being used, this current state assessment was leveraged to identify opportunities for its further use in signal assessment to enhance patient safety and public health.
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December 13, 2022
The intent of this survey is to understand the current state of use of rapid RWD analyses for signal assessment in the light of feasibility, speed, and regulatory requirements. Further, the survey was leveraged to identify potential opportunities and approaches to complement signal assessment by rapid analysis of RWD to help overcome resource and time constraints and to potentially enhance patient safety and public health.
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September 15, 2022
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September 13, 2022
This overview provides background on the PV Agreements Optimization (PVAO) initiative which seeks to produce a customizable, interactive resource for new and experienced contract partners, which could be used to inform and/or streamline their PVA process development, contract drafting, and negotiations.
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June 29, 2022
Member Company end user shares the application of Historical Trial Data (HTD) in a control arm supplementation use case, highlighting the opportunity and challenges of using this data, and learnings from health authority discussions. Not for circulation outside member companies.
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