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In Good Pharmacovigilance Practices (GVP) Module VI, adverse event reporting is a crucial aspect of ensuring the safety of medicinal products. Here’s an overview of adverse event reporting based on GVP Module VI:
1. Definition of Adverse Event (AE) and Serious Adverse Event (SAE): GVP Module VI typically provides definitions for adverse events and serious adverse events. An adverse event is any untoward medical occurrence associated with the use of a medicinal product, while a serious adverse event is an event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
2. Reporting Requirements: Module VI outlines the requirements for reporting adverse events to regulatory authorities, such as the FDA in the USA. This includes the timeframe within which adverse events must be reported, typically emphasizing the importance of timely reporting, especially for serious adverse events.
Sponsor-investigators have reporting responsibilities when adverse events occur in their study. In addition to submitting these events to their IRB, they must also submit in respect to the protocol’s data safety monitoring plan and to the FDA following FDA regulation 21 CFR 312.32(c). Reporting of these events to the FDA are required for all IND/IDE holders.
Initial reporting: Any suspected adverse events or any adverse events that are considered serious and unexpected must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event. Unexpected fatal or life-threatening suspected adverse events must be reported to the FDA as soon as possible but no later than within 7 calendar days of first being notified of the event.
Follow-up reporting: Any relevant additional information obtained related to the initial report should be submitted as a Follow-up Safety Report and must be reported to the FDA as soon as possible but no later than within 15 calendar days of first being notified of the event.
Adverse events that don’t meet these categories should be submitted with your annual report with a summary of all events that have occurred.
3. Format and Content of AE Reports: Guidelines are provided regarding the format and content of adverse event reports submitted to regulatory authorities. This includes the information that should be included in the report, such as details about the patient, the medicinal product(s) involved, the adverse event itself, and any actions taken in response to the event.
The IND/IDE should be submitted to the respective office in the FDA that monitors your IND/IDE: CDER, CBER or CDRH
4. Electronic Reporting: Module VI may also address electronic reporting requirements, emphasizing the increasing use of electronic systems for the submission of adverse event reports. This includes specifications for electronic data formats and transmission methods.
5. Follow-up Reporting: Guidance is provided on follow-up reporting, which may include providing additional information about reported adverse events as it becomes available, as well as reporting on the outcome of any actions taken in response to the events.
6. Global Harmonization: GVP Module VI may also emphasize the importance of global harmonization in adverse event reporting, encouraging consistency in reporting requirements and procedures across different regulatory jurisdictions.
7. Training and Compliance: Pharmaceutical companies are typically required to ensure that personnel involved in adverse event reporting are adequately trained and comply with the reporting requirements outlined in GVP Module VI.
Adverse event reporting is a critical component of pharmacovigilance, as it helps regulatory authorities monitor the safety of medicinal products and take appropriate actions to protect public health. Compliance with the requirements outlined in GVP Module VI is essential for pharmaceutical companies to fulfill their pharmacovigilance obligations and maintain regulatory compliance.