Second industry stakeholder platform on the operation of European Union pharmacovigilance legislation

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TitleSecond industry stakeholder platform on the operation of European Union pharmacovigilance legislation
Date12/01/2015 - 12/01/2015
LocationEuropean Medicines Agency, London, UK
SummaryThis meeting focused primarily on experience with risk-management plans (RMP) and post-authorisation safety studies (PASS), with regulators presenting an update on recent developments and stakeholders providing valuable practical feedback on the available guidance and templates. An update on the development of a scientific and regulatory guideline for post-authorisation efficacy studies (PAES) was also provided. Registration by invitation only. Registration closed.

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