Individual Case Safety Reports Clause Samples
The 'Individual Case Safety Reports' clause establishes the requirements and procedures for reporting specific safety events or adverse reactions related to a product, typically in the context of pharmaceuticals or clinical trials. It outlines the obligations of the parties to collect, document, and promptly share detailed information about any individual incidents that may impact patient safety, such as unexpected side effects or serious adverse events. This clause ensures that all relevant safety data is communicated efficiently and in compliance with regulatory standards, thereby supporting patient protection and regulatory compliance.
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Individual Case Safety Reports. The Party holding the Regulatory Authority Authorisation for the Product for clinical trials in a country shall be responsible for submitting SAE reports to the Regulatory Authority in that country according to the current applicable laws, regulations and guidelines, regardless of whether the report originated from that Party or not. Information on which Party holds the Regulatory Authority Authorisation for the clinical trials will be exchanged and updated at the time of the transfer of the reports to the other Party. The Party holding the Regulatory Authority Authorisation for clinical trials shall be responsible for the electronic submission to the EMEA of all reportable cases for the Product to Clinical Trial Modules, as required.
Individual Case Safety Reports. 8.1.1 Licensee shall be responsible for its own medical assessment of the reported ADRs when entering the report into Licensee’s safety database according to local requirements and its internal SOPs. In general, the principle of the implied positive causality (meaning that the report is considered to be related with regard to further Licensee and regulatory submission) shall be applied to all Spontaneous Reports of ADRs. Licensee shall assess the expectedness, seriousness and causality according to local requirements and their internal SOPs. Licensee will provide information about reported ADRs to Oncolytics and solicit comment from Oncolytics for reports to be entered into Licensee’s safety database. Oncolytics will respond promptly to any request for comment received from Licensee.
8.1.2 ICSRs shall be sent to the Qualified Person of Oncolytics. The reports shall be distributed in Oncolytics safety networks according to Oncolytics’ SOP.
8.1.3 ICSRs in Licensee’s safety database shall be crosschecked at regular intervals to ensure that all the applicable ICSRs are appropriate according to this Agreement.
Individual Case Safety Reports. Aspen will provide to Iroko case reports for the Medicinal Products that meet the Valid Case criteria as defined in this Agreement.
Individual Case Safety Reports. Format and content for the reporting of one or several suspected Adverse Reactions to a medicinal product that occur in a single patient at a single time point. The company which has been granted authorisation(s) by the relevant regulatory authorities, necessary to market the Medicinal Product in a given country/region and therefore the legal responsibility to comply with pharmacovigilance requirements.
Individual Case Safety Reports