Roll up your sleeves for a two-day, introductory workshop on how to prepare an effective electronic Common Technical Document (eCTD) submission. This in-person workshop includes skill-building, interactive exercises, case studies and small group discussions.
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A look at the blended approach and other options for an
outsourced pharmacovigilance model and their benefits for small pharmaceutical
companies. This article provides advice on the steps required to complete a
successful PV outsourcing project.
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Health Canada says it is boosting its efforts to inspect pharmaceutical manufacturers, and promises to be more transparent with inspection results in the future.
overview of expedited pathways for US medical devices that are alternatives to Traditional
510(k)s and Premarket Approval Applications (PMAs). These include Special
510(k), Abbreviated 510(k) and Humanitarian Device Exemption (HDE) submission types.