2014-02-20 13:07:36 - SMi’s Benefit-Risk Assessment for the New PSUR masterclass - hosted by OXON epidemiology will take place on the 14th April in London
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
For more information and full programme details please visit: www.smi-online.co.uk/2014benefit-risk-psur4.asp