Quantitative Benefit-Risk Assessment for the New PSUR
Seminar - London, United Kingdom
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 hosted 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.
Organization: SMi Group
(Courtesy of Holiday Inn Bloomsbury, London, United Kingdom, via tripadvisor.co.uk)
Quantitative Benefit-Risk Assessment for the New PSUR
Mon, Apr 14, 2014 - Mon, Apr 14, 2014 (10:00 to 18:00)
Holiday Inn Bloomsbury, London, United Kingdom
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