SMi Group are proud to introduce its masterclass taking place on 2nd December 2014 in Central London, Quantitative Benefit Risk Assessment for the new PSUR and Risk Minimisation.
Quantitative Benefit Risk Assessment will be hosted by OXON Epidemiology Ltd. OXON is a consultancy and CRO that specialises in real word data: Epidemiology (field and database studies and patient registries), Safety (PASS studies, statistical signal analysis, benefit-risk analysis, risk management), HEOR, Meta-analysis, development of concept protocols, and Evidence strategy for pre-and post-approval products.
The 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, and approaches to evaluate the positive and negative effects of risk minimisation measures.
Key Benefits of Attending:
Understand the requirements of the European GVP legislation for the New PSUR
Learn the concepts behind quantitative BRA and why and when quantification is necessary
Know the process for undertaking BRA and the evidence and data requirements
Describe the role of quantitative models in BRA and understand regulatory expectations including the current opinion of the European working groups
Evaluate the methodological options available and discuss their pros and cons
Appreciate the principles and practice of statistical BRA including the advantages and disadvantages of the principal methods
Discuss how to implement/optimise BRA for the new PSUR in your company for old and new products, and learn what other companies are implementing
Learn approaches to evaluate the negative and positive effects of risk minimisation measures
Please note that availability is based on a first come first serve basis and is strictly limited.
Category: Conferences | Science, Health & Medicine | Pharmaceuticals | Regulatory Affairs
Price: Standard Rate: £599+VAT
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