Ensuring compliance with E2B(R3) drug safety regulations
Built specifically to support the E2B(R3) EudraVigilance system and MedDRA coding standards, SafetyEasy™ PV handles the reporting and management of all serious and non-serious adverse events. Its future-proof approach is able to generate PSUR, PBRER, and DSUR documentation and is ready for forth-coming standards such as IDMP.
Through a EMA certified gateway, SafetyEasy™ PV provides you with a direct link to the regulatory authorities, eliminating the need for manual submission of reports.
In addition, SafetyEasy™ PV also enables you to readily track and monitor the status of workflows. Through email notifications and online dashboards SafetyEasy™ PV provides users with reminders about imminent activities they need to perform. This helps ensure that submission deadlines are met, and other legal obligations are not overlooked.
Cloud-based pharmacovigilance service
As a secure, cloud-based service, SafetyEasy™ PV is lightning quick to implement and requires no customization. In many instances, SafetyEasy™ PV can be configured and validated within two weeks. Its simple, intuitive and user-friendly interface speeds user adoption and eliminates the need for extensive training.
Used by more than 300 organizations across 90 countries SafetyEasy™ PV is the simplest and most cost-effective way to ensure effortless compliance with current and future drug safety regulations.SafetyEasy™ PV is compliant with the following regulatory guidelines:
- ICH, EMA and FDA regulations and directives related to reporting of an adverse event
- EU GMP Annex 11
- US FDA 21 CFR part 11
- EMA’s Good Pharmacovigilance Practice (GVP) guidelines