![]() In the United States these reports are referred to as a Periodic Adverse Drug Experience Reports (PADERs). ![]() In most countries post-marketing periodic reports are referred to as a Periodic Safety Update Reports (PSURs) or Periodic Benefit Risk Evaluation Reports (PBRER)s.The timing and content of periodic reports for marketed products are based on local requirements (ie, every 6 months, every year, every 3 years, etc).Periodic reports provide an overall safety re-evaluation at defined time-points and contribute to the ongoing assessment of whether changes should be made to product information or the risk management plan.The purpose of these periodic safety reports is to provide an aggregate review and analysis of all adverse event reports received over a defined time period.Periodic safety reports are submitted to regulatory agencies in accordance with government regulations.The clock starts (day 0) on the date when any personnel of the MAH first receive a case report that fulfill the minimum criteria Non-Serious cases are reported within 90 calendar days to the EU health authority (EMA).Serious post marketing cases are reported within 15 calendar days to the NCA (national competent authorities)/HA (health authorities).Clinical trial other Serious cases and safety issues are reported in 15 days calendar days timeframe.Clinical Death/Life threatening cases and SUSAR (Suspected Unexpected Serious Adverse Reaction) cases are reported within 7 calendar days to the NCA (national competent authorities)/HA (health authorities).Globally ICSR are reported under 3 categories : The decisions on when and how to report individual case reports are based on the requirements of each country’s local law.Worldwide regulatory authorities require expedited submission of individual safety reports received by drug companies that meet certain, specific criteria, including criteria for the seriousness of a clinical event, whether or not a report has been previously observed and an assessment of the event’s relatedness to administration of the product.Pharma companies are required to report safety information to regulatory authorities according to specific timelines. Types of reports provided to regulatory authorities: Also, timelines in pharmacovigilancemake use of a concept called calendar days rather than weekdays or weekends. ICSR reporting timelines primarily vary based on the seriousness of an event and the nature of the reporter. Once ICSR assessed for seriousness, causality and labelling, case will be submitted to regulatory authority. Events are categorized as Adverse event (AE), Severe adverse event (SAE), Severe adverse reaction (SAR), Suspected unexpected serious adverse reaction (SUSAR), Life-Threatening (LT). The event is categorized based on the level of serious health effect on the affected patient. Once these conditions are satisfied an ICSR is filed for the adverse event that has occurred. The drug suspected of causing reaction/event.Once report is received it is checked for following four parameters ![]()
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