On Demand Content Preview Webinar: Challenges of Producing a PBRER: Transition from PSUR to PBRER

概要

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?

参加対象

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
Pharmacoepidemiology
Post-market studies and Real world Evidence Generation
Customer Engagement Programs, including Patient Support Programs
Medical Information
Medical Communications
Health Outcomes

学習目的

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.

On Demand Content Preview Webinar: Challenges of Producing a PBRER: Transition from PSUR to PBRER

概要

参加対象

学習目的

最新情報や機会を逃さないで