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I got it!

Discover how to implement best practice for benefit-risk analysis for PSUR


PSURs are a regulatory requirement for authorised medicines in the EU and some other countries. They are generated by companies for each of their products at specified intervals – in the EU every 6 months for the first 2 years of marketing, then annually until the first renewal (at 4.5 years) and then every 3 years. 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 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


14 Apr 2014 @ 12:00 am

14 Apr 2014 @ 12:00 am

Duration: 0 hours


Holiday Inn

6 Coram Street

Greater London

United Kingdom

Organised by

SMi Group Ltd.

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