23 -25 September 2014 Berlin, Germany


Dr Joerg Seebeck will be speaking at The Risk Management & Pharmacovigilance Summit, organised by the Allan Lloyds group, which will take place from September the 23rd to the 25th 2014 in Berlin, Germany. The conference will cover a range of topics including risk management plans and their implementation, benefit risk assessment process, pharmacovigilance system master file, post marketing surveillance, and drug safety risk management.

“Dr Seebeck will be speaking about Management of Emerging Safety Issues (ESI). The term “Emerging Safety Issue” has been introduced with the publication of the GVP modules. This presentation will explore the available regulatory guidance on ESI, help to interpret it, and discuss how MAHs in the EU should update their processes in order to adequately cover ESI-related requirements.”

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