Quantitative Benefit Risk Assessment for the new PSUR and Risk Minimisation

LONDON - Sept. 11, 2014 - PRLog -- Risk minimisation measures have negative as well as positive consequences and these should be evaluated. The PSUR will change from being largely a document based online listings, narratives and simple sales-based incidence statistics to a benefit-risk tool with a much more statistical and quantitative approach to adverse event data, and including the incorporation of efficacy data.

This full-day 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.

This masterclass will enable attendees to:
• Understand the requirements of the European GVP legislation for the New PSUR
• Appreciate the concepts behind quantitative BRA and why and when quantification is necessary
• Understand 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
• Understand methodological options available and 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

Hear from the three masterclass leaders:
• Nawab Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.) Clinical Epidemiologist & Head at OXON Epidemiology
• Ignacio Mendez VMD MPH, Director of HEAOR & Field Analytics at OXON Epidemiology’s Centre for Real World Field Studies, Madrid.
• Andrew Maguire BSc MSc FSS, Director of Global Epidemiology & Database Services at OXON Epidemiology’s Centre for Real World Secondary Data, London.

For further details or to download a brochure visit us online at www.smi-online.co.uk/2014risk-assessment-psur8.asp (http://www.smi-online.co.uk/2014risk-assessment-psur.asp)
For more information contact: Andrew Gibbons on +44 (0) 207 827 6156 or email agibbons@smi-online.co.uk

Masterclass Programme:

9.00 Registration & Coffee
9.30 Welcome and Introductions
9.45 Regulatory expectations for the new PSUR (PBRER)
10.30 Understanding quantitative concepts (1)
11.00 Morning Coffee
11.20 Understanding quantitative concepts (2)
12.00 Methodologies of benefit-risk assessment
1.10 Networking Lunch
2.00 Statistical Methods & Data Requirements
3.20 Afternoon Coffee
3.40 Discussion: Planning for the new PSUR for new and old products in your company
4.15 Evaluation of the positive and negative effects of additional risk minimisation plans
5.15 Review of the Day
5.30 End of Masterclass

For full masterclass programme visit www.smi-online.co.uk/2014risk-assessment-psur.8asp (http://www.smi-online.co.uk/2014risk-assessment-psur.asp)

---END---

About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. We hold events in over 30 major cities throughout the world including London, Paris and Singapore and to date have welcomed over 200,000 participants from 80 countries. More information can be found at http://www.smi-online.co.uk