Enroll Course: https://www.udemy.com/course/periodic-benefit-risk-evaluation-report-pbrer-with-template/
For those entrenched in the world of Pharmacovigilance, particularly those handling Individual Case Safety Reports (ICSRs), the desire to broaden horizons and explore new avenues within the field is a common aspiration. If you’re looking to transition from ICSR case management to the crucial domain of aggregate safety reporting, then the Udemy course ‘Periodic Benefit-Risk Evaluation Report PBRER – With Template’ is an exceptional resource.
This course is meticulously designed for professionals aiming to shift their careers within PV, specifically towards writing aggregate safety reports. The Periodic Benefit-Risk Evaluation Report (PBRER) is a cornerstone of pharmacovigilance, serving as a globally accepted document for the periodic assessment of benefit-risk profiles of medicinal products already on the market. Understanding and mastering PBRERs is therefore essential for career advancement in this sector.
The course excels by breaking down each section of the PBRER, providing the necessary fundamental content and then demonstrating drafting principles using a practical PBRER template. This hands-on approach, guided by an experienced lead trainer with extensive experience in drafting various safety reports and project management, ensures a deep and practical understanding of the concepts.
What you can expect to learn:
* **Foundational Knowledge:** A solid brush-up on the basics of aggregate safety reports before diving into PBRER specifics.
* **Theoretical Framework:** A comprehensive overview of PBRER objectives, principles, and report sections, setting the stage for in-depth learning.
* **Section-by-Section Deep Dive:** An exhaustive exploration of each PBRER section and subsection, focusing on key content and drafting techniques.
* **Assessment Reports & PSUSA:** An explanation of PBRER Assessment Reports and the crucial concepts of the PSUSA (Periodic Safety Update Single Assessment) procedure, including EMA feedback mechanisms.
* **Project Management Essentials:** Valuable bonus lectures on project management aspects vital for PBRER production, covering workflows, review processes, submissions, and stakeholder interactions.
Upon completion, you will not only gain a strong grasp of aggregate safety report fundamentals and PBRER drafting principles but also the confidence to pursue opportunities in this specialized area. This course equips you with the skills and knowledge to confidently face interviews for aggregate safety report positions. Embrace this opportunity to realize your professional dreams in pharmacovigilance!
Enroll Course: https://www.udemy.com/course/periodic-benefit-risk-evaluation-report-pbrer-with-template/