Benefit-risk assessment in Pharmacovigilance and in PBRERs MasterClass with a special focus on PSURs - US edition
22-23 February, 2024
The training will provide practical advice on benefit risk framework and assessment
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.
22-23 February, 2024, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
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 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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RECOMMENDATION
Who should attend?
• 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 it’s 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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