The E2B(R2) standard was first adapted in February 2001. Since then, many changes have been made across the countries where it applies. These changes have promoted an update to E2B(R2) with the new E2B(R3) - which will have a major impact on pharmacovigilance systems and processes, particularly on adverse event reporting and collection of data on drugs. Based on QuintilesIMS’s extensive experience in this area, this insight brief examines how the new standards impact day-to-day safety operations and offers tips for project management of the implementation of the new standards.
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