Quantitative Benefit-Risk Assessment for the New PSUR

The latest legislation waives the obligation to submit PSURs routinely for generic products, well-established use products, homoeopathic products, and traditional herbal products. The submission frequency will be variable and risk based. For these, PSURs shall be submitted where there is a condition in the MA or when requested by a Competent Authority on the basis of concerns relating to pharmacovigilance data or due to the absence of PSURs for an active substance after its authorisation.

SMi's masterclass hosted by OXON Epidemiology will provide attendees with the necessary exposure to approach the elements of benefit-risk analysis for the new PSUR in their company for new and old drugs. This course has been developed for those who have no previous training in writing PSURs as well as those who have a basic knowledge which they wish to improve, and for those who are familiar with the old PSURs, but who now need to learn more about the challenges of the new legislations.

Key benefits to this masterclass are:
• To understand the latest updates to the new PSUR concepts
• Learn how to implement best practice for benefit-risk analysis for PSUR
• Understand the importance of quality in benefit-risk assessment
• Enhance capability by planning a draft PSUR for the risk benefit assessment