99 PV Red Sheet Practice Exam

In pharmacovigilance, protecting personal data collected in safety reports is essential, because these records often include health information about identifiable individuals. The General Data Protection Regulation provides comprehensive rules for processing personal data, including health data, with requirements for a lawful basis, data minimization, strong security measures, data subject rights, and breach notification. It also has extraterritorial reach, so organizations outside the EU must comply when EU residents’ data are involved, which is crucial for international pharmacovigilance collaborations. While HIPAA protects health information in the US and PIPEDA or CCPA cover privacy in their respective regions, GDPR offers the broad, globally applicable framework most directly relevant to safeguarding data in pharmacovigilance across borders.