April 19, 2024
Featured Solution: Table of Contents A sponsor company used the Pharmacovigilance Agreements Optimization “Table of Contents” solution in the following ways: Updating an internal PVA template to improve quality and complianceThe company was conducting an annual review of its pharmacovigilance agreements (PVAs) and leveraged the “Table of Contents” (TOC) to improve the quality of the…
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November 8, 2023
Featured Solution: Pharmacovigilance Agreements (PVAO) “Glossary” Our company has multiple instances of the use of TransCelerate’s Pharmacovigilance Agreements Optimization (PVAO) “Glossary.” Our company regards the Glossary as a trusted resource, especially because we are familiar with the effort, including the identification of regulatory sources, that went into the development of this key solution but also…
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November 8, 2023
Featured Solution: Pregnancy and Breastfeeding Landscape Assessment We leveraged the Pregnancy and Breastfeeding Landscape Assessment to completely revise our “Clinical and Post-market Pregnancy Follow-Up” forms into a single, streamlined form. The pregnancy follow-up form is used globally to obtain follow up information on the pregnant mother and the course and outcome of the pregnancy. This…
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May 25, 2023
Featured Solution: Interactive (ICSR) & Automation Technologies Tool (IATT) “Through the data presented within TransCelerate’s ‘Interactive ICSR & Automation Technologies Tool’ (IATT), our member company was able to adjust our short-term automation strategy for pharmacovigilance. By examining the IATT’s data for the maturity of automation implementation using robotic process automation (RPA), we had a strong…
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May 25, 2023
Featured Solution: Presentation of Safety Risks Across the Lifecycle (PoRTL) Framework Background “A large pharmaceutical company has used the ‘Presentation of Safety Risks Across the Lifecycle (PoRTL) Framework’ to train entry-level safety physicians to familiarize them with key pharmacovigilance guidances and aid them in presenting risks for products. In a discussion about the Framework and…
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July 15, 2020
A letter to the editor of Clinical Trials, noting a trend towards divergence of pharmacovigilance regulations. This letter is a call for re-harmonization to raise awareness of the issue and call for all stakeholders, in particular Health Authorities, to take efforts to re-harmonize.
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July 15, 2020
Provides information regarding the types of technologies available in pharmacovigilance and maps the level of implementation of each technology to the Individual Case Safety Report (ICSR) process.
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July 15, 2020
This paper highlights opportunities and provides an initial starting point for companies considering ICSR process automation. Supplemented by the Interactive ICSR & Automation Technologies Tool (IATT).
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July 15, 2020
This manuscript highlights industry challenges in operationalizing the requirements of the 2017 Clinical Trial Facilitation Group (CTFG) Question & Answer document. Surveys reveal actions taken in the creation, submission and implementation of the Reference Safety Information (RSI) to meet the requirements of the CTFG and EU national competent authorities whilst staying compliant with global regulatory…
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July 15, 2020
An Implementation Guide to aide pharmaceutical manufacturers‘ understanding of ambiguous areas of the PMSR for Combination Products Draft Guidance for Industry and FDA Staff. In addition, a webinar presentation is included where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations Implementation Guide.
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