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.




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.