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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 14th June 2011, 06:59 AM
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JohnMack JohnMack is offline
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Default Social Media Guidance for Adverse Event Reporting

Source: The ABPI Pharmacovigilance Expert Network

The ABPI Pharmacovigilance Expert Network (PEN) recognises the value of using social media to communicate externally with customers. Despite the obvious benefits of using social media, there are regulatory and legal considerations due to the inherent nature of this channel. Attention to company values, legal and policy requirements are necessary for successful participation in the social media environment. These guidance notes provide suggested best practices for the monitoring and management of adverse events (AEs) and product complaints (PCs) from social media use in company sponsored websites. They have been developed by the ABPI and shared with the Medicines and Healthcare Products Regulatory Agency (MHRA).

[See guidance document attached.]
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File Type: pdf ABPI SM AE guidance.pdf (172.2 KB, 507 views)
John Mack, Editor & Publisher
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