, Volume 34, Issue 10, pp 883-1026
Date: 03 Jan 2013

International Society of Pharmacovigilance Abstracts 11th ISoP Annual Meeting ‘Next Stop: Istanbul — Bridging the Continents!’ Istanbul, Turkey 26–28 October 2011

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Oral Presentations

Risk Management Plans

OP01. Training on Risk Management Planning

E. Brown

Elliot Brown Consulting Ltd, Primevigilance Ltd, UK

Risk management planning for medicines has assumed increasing importance in recent years[13] but associated training needs may not have been clearly defined. There are several groups for whom training may be valuable in the context of Risk Management Plans (RMPs). These include: top management who are responsible for overall strategy, allocation of resources, planning and budgets in pharmaceutical companies; department heads in pharmaceutical companies who commission RMPs; individuals or groups (in pharmaceutical companies or contract organisations) who contribute to, write or update RMPs; company personnel who review or approve RMPs; regulators who assess the RMPs.

There are various subjects for the training, depending on who is being trained: understanding concepts of risk management and how these apply to medicines; knowledge of why risk managem ...