This event will highlight the impact of the new Pharmacovigilance legislation on regulatory affairs from various perspectives. The changes in legislation affect the way product assessment is carried out in both pre- and post-authorisation phases, introduce new obligations to Marketing Authorisation Holders, and bring in continuous benefit risk assessment. In this conference we will also be looking at the impact of the new Pharmacovigilance Risk Assessment Committee (PRAC) on the life-cycle management of products and the PRAC's interactions with other Committees.

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