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  • Regulatory NewsRegulatory News

    EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events

    The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events. In the lead up to the launch of the new EudraVigilance system, EMA says national competent authorities, marketing authorization holders (MAHs) and sponsors of clinical trials have to make  final preparations  to ensure that their processes and IT infrastructures can work with the new...
  • Regulatory NewsRegulatory News

    WHO Makes Drug Side Effects Easier to Find With New Database

    Last week, the World Health Organization (WHO) boosted its transparency efforts with the launch of a new, open access drug safety database called VigiAccess. Background The practice of postmarket drug monitoring, or pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. During clinical trials, it is not possible to determine every possible side effect or reaction to a drug or vaccine. By monitoring drugs and collecting re...
  • Regulatory NewsRegulatory News

    With New Rule in Place, FDA Establishes Procedures for Submitting Vaccine Safety Problems

    A new draft guidance document issued this week by the US Food and Drug Administration (FDA) establishes best practices for the submission of safety reports related to the use of vaccines. Background FDA has since 2009 been advocating for a rule which would require all mandatory postmarketing safety reports to be submitted to the agency in electronic form (instead of paper), saying that the change could allow it to better process, review and archive the documents. The r...
  • Regulatory NewsRegulatory News

    FDA Launching Pilot Program to Assess Vaccine Safety Reporting Capabilities

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) is launching a pilot program intended to assess its capacity to receive reports of adverse events related to the use of vaccines. At present, CBER—working in tandem with the Centers for Disease Control and Prevention (CDC)—receives vaccine-related adverse events electronically through its Vaccine Adverse Event Reporting System (VAERS), which accepts the International Conferenc...