On Demand Content Preview Webinar: Challenges of Producing a PBRER: Transition from PSUR to PBRER
The on demand webinar recording is approximately 1 hour long, available in Portuguese only.
Periodic benefit-risk evaluation reports (PBRERs) were introduced in 2012 as part of the pharmacovigilance legislation regulation. The E2D Guideline was developed by the ICH Expert Working Group and was adopted by the European Union, Japan, and the USA. Shortly, the Brazilian Health Authority will adopt these guidelines with its agreement to harmonize to ICH standards by 2021.
How will this change increase transparency and allow for an improved benefit-risk profile for a medicinal product throughout its lifecycle. How will the PBER compare to the Periodic Safety Update Report (PSUR) and what changes will there be?
Who should attend?
Professionals who work in the area of:
- Drug Safety/Pharmacovigilance
- Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
- Benefit-risk assessment and Communication
- Regulatory Affairs
- Medical Product Safety Assessment
- Clinical Research
- Post-market studies and Real world Evidence Generation
- Customer Engagement Programs, including Patient Support Programs
- Medical Information
- Medical Communications
- Health Outcomes
At the conclusion of this content preview webinar, participants should be able to:
- Describe the main differences between a PSUR and a PBRER
- Analyze the challenges of producing a PBRER from a writing perspective
- Discuss the assessment of evidence, signal and risk evaluation, data in summary tabulations, exposure data, signal detection, missing information, and additional information requested
Continuing Education Credits are not available for this event.