Risk minimisation measures: Implementation, evaluation and results in the EU

Join SMi's Risk minimisation measures: Implementation, evaluation and results of EU studies in 2014 event on the 15 July

15 Jul 2014 at Holiday Inn Bloomsbury, London, United Kingdom

Medical & Health Care, Health & Fitness

Risk minimisation measures: Implementation, evaluation and results in the EU 15 Jul 2014 Holiday Inn Bloomsbury, London, United Kingdom
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The responsibilities for all stakeholders involved are set out in GVP Module XVI for Risk Minimisation . It is important to ensure that additional risk minimisation measures, including assessment of their effectiveness, do not introduce undue burden on the healthcare delivery system, the marketing authorisation holders, the regulators, and, most importantly, on the patients. The necessity to have a clearly defined objective in order to minimise risks and/or optimise the risk-benefit balance is becoming increasingly important.

SMi's masterclass hosted by Oxon Epidemiology will provide delegates the opportunity to learn about risk minimisation studies, their implementation and evaluation in Europe from two EMA experts: a regulator from the EMA PRAC committee and a clinical Pharmacoepidemiologist at ENCePP.

Why you should attend:

Discuss your challenges in risk minimisation

Evaluate effectiveness of planned and ongoing risk minimisation

Learn from real-life case studies and exercises

Analyse the principles of risk management

Increase effective alignment of risk studies and regulators

Gain insights into the benefits of using an evidence-based toolkit

When
From: July 15, 2014 08:30
To: July 15, 2014 17:30
Where

Holiday Inn Bloomsbury, Coram Street, WC1N 1HT, London, United Kingdom

Category

Medical & Health Care, Health & Fitness

Contact email
dlee@smi-online.co.uk

Contact phone
+44 207 827 6078

External link

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evvnt Platform

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