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New Challenges in Pharmacovigilance—Preparing for ICH E2B (R3) and IDMP Implementation

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September 21, 2016

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Summary

Both the EMA and FDA are in the process of rolling out new ICH technical standards for adverse event reporting and collection of data on medicines. With the ICH E2B R3 standard implementation deadline fast approaching, companies are facing an overhaul of several key ICSR processes and procedures.

During this webinar, Quintiles safety system and pharmacovigilance experts will discuss how the new standards impact day to day safety operations and outline some top tips for project managing the implementation of the new standards.  We will look at systems and business processes that are impacted AND outline a plan to support compliance once the standards come into force.

Speakers

Paul Kelly
Subject Matter Expert for the Lifecycle Safety Systems Group
Quintiles

Barry Mulchrone
Director / Market Product Safety unit/ Lifecycle Safety Systems Group
Quintiles