Periodic Benefit–Risk Evaluation Report PBRER –With Template

Learn Key concepts of PBRER writing and guidance for draft exposure using a PBRER template
What you'll learn:
Aggregate Safety Reports in Pharmacovigilance: PBRER as a major aggregate report type, Using Template to learn PBRER drafting
Periodic Benefit Risk Evaluation Report (PBRER): Understanding concepts all PBRER sections with emphasis on Safety Sections
Understanding the process of authoring an Aggregate Safety report
EMA PSUSA Procedures: Handling PBRER Assessment reports[AR]
Project management for PBRER production: Workflows of authoring, review, strategy meetings, stakeholder interactions
Requirements:
Understanding of Pharmacovigilance Fundamentals
Experience in PV ICSR Operations
Good quality of Internet connection
Basic level of English
Description:
This course is designed exclusively for professionals working in Pharmacovigilance ICSR Case management, aspiring to learn and explore other domains of PV, especially to shift their careers within PV from ICSR to writing aggregate safety reports.In Pharmacovigilance, Periodic Benefit-Risk Evaluation Report[PBRER] is a major aggregate safety report type which is accepted worldwide for periodic assessment of benefit risk profiles for the medicinal products that are in market.Each section of PBRER is explained with required fundamental content and utilised our PBRER Template to teach the drafting principles of PBRER.One of the experts in our community is a lead-trainer for the aggregate safety reports who has significant experience in drafting various kind of safety reports in pharmacovigilance, including project management. Our SME in this domain will take you through the PBRER concepts using template for your better understanding.You will learn following concepts in this course:We will brush you with the basics of aggregate safety reports before starting PBRER conceptsWe will provide theoretical background to PBRER[objectives, principles, report sections etc] to have a high-level overview before deep diving into each section of the report.Now, you will enter into core section of the course, where you will learn each section and subsections of PBRER, including the key content and drafting concepts of PBRER.After completion of our main part of course, we will explain what are PBRER - Assessment Reports and key concepts of PSUSA procedure in providing feedback to the PBRERs submitted by MAHs to the EMA.At the end, we will provide bonus lectures by giving some project management tips that are essential for production of a PBRER which included general workflows of authoring, review, submissions, strategy meetings with key stakeholders etc.After completion of this course, you will gain new skill in fundamental concepts of aggregate safety reports including the key objectives and principles of drafting a PBRER. With that you can be confident to shift your career into this domain by facing interviews in Aggregate Safety Reports.Our Best Wishes to all learners to realise their professional dreams in their career!
Who this course is for:
Working Professionals in Pharmacovigilance with experience in Case processing, literature
Graduate or postgraduate degree in Medical sciences, Pharmaceutical sciences or Life sciences.
Beginners in PV training to explore concepts of aggregate safety reports[like PBRER] in Pharmacovigilance
Homepage

https://www.udemy.com/course/periodic-benefit-risk-evaluation-report-pbrer-with-template/