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Published on: August 30, 2018
Ongoing challenges in pharmacovigilance
1US Food and Drug Administration, 10903 New Hampshire Ave., Building 22, Room 4304, Silver Spring, MD, USA, gerald.dalpan@fda.hhs.gov.
Abstract:
While pharmacovigilance systems have made substantial progress in the past several decades, all pharmacovigilance systems face a common set of ongoing challenges in drug safety surveillance in five principal interrelated areas: engaging the public, collaboration and partnerships, incorporating informatics, adopting a global approach, and assessing the impact of efforts. In broad terms, these challenges are not new. Rather, advances in science and technology, along with more demanding societal expectations, have changed the nature of these challenges and provided new opportunities to move the field forward. Differences in organization and levels of development, as well as regional differences, necessarily imply that a single approach is not suitable for all regions, though sharing of best practices can help each region.
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