Challenges of Producing a PBRER: Transition from PSUR to PBRER

On-Demand Content Preview Webinar

In this webinar...

Periodic benefit-risk evaluation reports (PBRERs) were introduced in 2012 as part of the pharmacovigilance legislation regulation. The E2D Guideline was developed by the appropriate ICH Expert Working Group and was adopted by the European Union, Japan, and the USA. Shortly, it will also be adopted by the Brazilian HA, upon the agency agreement to harmonize the process to ICH guidelines until 2021.

The introduction of PBRERs answered the call for increased transparency and a clearer focus on the benefit-risk profile in a medicine's lifecycle, compared with the previously produced Periodic Safety Update Report (PSUR).

PBRERs provide a valuable opportunity for critical discussion as the PBRER considers not only the information that has become available during the time period of the PBRER, but also evaluates the data in the context of cumulative information.

NOTE: This content preview webinar will broadcast live in Portuguese only.

Learning Objectives

  • Describe the main differences between PSUR and 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

Presenter

  • Jorge Safi, MD, PhD, Senior Global Program Safety Lead, Novartis Pharmaceuticals, Brazil