PSUR and RMP - Benefit Risk Masterclass with workshop - US edition
22-24 September, 2025
A comprehensive overlook on benefit risk assessment in PSUR and RMP
The training will provide practical advice on benefit risk framework and assessment and how it is used in the writing and preparation of PBRERs.
22-24 September, 2025, Virtual
Time Zone: Eastern Daylight Time (EDT) / UTC-04:00
Overview
The focus of the Periodic and Benefit Risk Evaluation Reports (PBRERs) two-day online training will be providing an update of ongoing activities regarding periodic safety evaluation and review of the benefit risk of medicinal products. The training will provide practical advice on the benefit-risk framework and assessment, and how it is used in the writing and preparation of PBRERs. During the training, a holistic approach and practical examples on the connection between signal and risk management with PBRERs will be given.
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WHO SHOULD ATTEND
This course is intended for professionals working within the pharmaceutical industry in pharmacovigilance, regulatory affairs, and medical writing positions. Junior professionals within pharmacovigilance and medical writing will benefit from this training, getting an introductory course in benefit-risk and safety periodic writing, as well as more senior professionals who wish to extend their professional skills in aggregate reports.
-Safety experts
-Periodic safety reporting
-Risk management planning and development of formal Risk Management Plans/REMS
-Medical writers
-Regulatory strategy and regulatory affairs
-Clinical research
-Medical Affairs
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today its an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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