The resources below were developed by the Interpretation of Guidances & Regulations Initiative as part of their mission to proactively work with health authorities toward modernized and internationally harmonized pharmacovigilance.

Materials

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Description

To meet these goals, we at TransCelerate implore representatives for regulatory authorities to work with industry sponsors, in the spirit of ICH, to identify potential ways to re-harmonize global pharmacovigilance processes and requirements.

A webinar presentation where TransCelerate team members provide an overview of the FDA Post Marketing Safety Reporting for Drug-Device Combinations  Implementation Guide.