June 3, 2024
In this session, the TransCelerate Board of Directors explores the critical role of collaboration in addressing the foremost challenges in R&D. Discover how TransCelerate is uniquely positioned to contribute significantly to the healthcare ecosystem, with an unwavering focus on putting patients at the center of all our initiatives.
Explore
May 24, 2024
This file provides an overview of the Optimizing Data Collection initiative, e.g., vision, scope, objectives, etc.
Explore
March 26, 2024
This file provides an overview of the Enabling Translational Safety initiative, e.g., vision, scope, objectives, etc.
Explore
February 5, 2024
Raise awareness and help stakeholders understand the evolution and the value of adoption of Clinical Data Sharing.
Explore
January 11, 2024
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.
Explore
November 14, 2023
This file provides an overview of the first six drug safety topics completed under the IGR-PV initiative.
Explore
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.
Explore
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.
Explore
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.
Explore
April 11, 2023
Provides an overview of the Rapid Signal Assessment Using RWD initiative and its solutions.
Explore
