THOUGHT LEADERSHIP

Current European law prohibits businesses from sending personal information about European citizens to companies in the United States (US) without specific contractual obligations to protect the privacy of the information.  However, the current Data Privacy Framework (DPF) allows US companies that are “Certified” under the Framework to import and process personal data of European citizens without these contractual requirements.

Pharmacovigilance is one of the most essential functions in the drug development process as it is vital for the continued safety evaluation of a product from the first time it is administered to a person through the post-marketing setting. A Pharmacovigilance program must be set up to detect, assess, understand and prevent adverse effects or other possible drug-related problems, and these activities require extensive documentation and monitoring. The global safety database is the primary tool to support Pharmacovigilance activities as it allows us to review safety cases across an entire investigational program rather than study-by-study. It is the Pharmacovigilance provider’s responsibility to ensure that the database is updated and maintained by inputting individual case safety reports (ICSRs) in a consistent, standardized, and timely manner.