Expedited Reporting. 1.1 Each party shall report to the other party Serious Adverse Drug Reactions regarding the Product within a maximum of [ * ] from being received by either party.
Expedited Reporting. SUSARs are subject to expedited reporting. The process will be further described in the Study Specific Safety Management Plan. The Sponsor has authorised the CRO to execute its responsibilities for expedited safety report submission to the appropriate regulatory authorities within specific time periods of being notified of the event (within 7 or 15 calendar days depending the character of the SUSAR); therefore, it is important that the Investigator submit additional information requested as soon as it becomes available.
Expedited Reporting. All SAEs must be reported to Philips within 24 hours of the Investigator becoming aware of the event. Additionally, any medical device deficiencies that might have led to a SAE if: • suitable action had not been taken; • intervention had not been made; or • circumstances had been less fortunate must also be reported to Philips within 24 hours of the Investigator becoming aware of the event. Furthermore, any new findings or updates in relation to previously reported SAE or device deficiencies which may have potentially led to SAE must be reported to Philips within 24 hours of the Investigator becoming aware of the new findings or updates.
Expedited Reporting. Supplier is responsible for determining seriousness, expectedness per the package insert and the company's opinion of relatedness. Supplier is responsible for preparing any regulatory forms for submission in the Territory. Teva will make the determination as to whether a report meets criteria for expedited reporting to regulatory authorities in the Territory. Teva will be responsible for submission of expedited reports to the regulatory authorities in the Territory. Both parties will submit the appropriate reports of individual case reports to the regulatory authorities of the countries in their territories within the time frames required by the current legislation in each ountry.
Expedited Reporting. The responsibility for expedited reporting of AEs relating to the Product(s) covered by this SDEA to regulatory authority in the Territory, as per applicable regulatory requirements in the Territory, will be that of SUNCMS and/or its delegate where the Product is available to patients and/or with the written Letter of Authorization/Delegation from the MAH SUN requested by applicable regulations in the Territory. Periodic Safety Reporting SUNCMS will be responsible for generation and submission of Periodic Safety Reports with the Product(s) covered by this SDEA as per applicable regulatory requirements in the Territory. SUN will be provided promptly, on request, with all the required information e.g. sales data to generate the report by CMS.. Information contained in Periodic Safety Report is the property of the Party generating them and proprietary rights will be respected. Each Party will keep the other informed of any recall related to Product(s) covered under the Business Contracts and any safety-related queries from regulatory authorities and co-operate in responding promptly. Risk Management Plan SUN will be responsible for preparing, maintaining, and updating and submitting Risk Management Plan in the territories as per applicable regulatory requirements. CMS will provide inputs to SUN for development and submission of a Risk Management Plan within the timelines in which information is requested by SUN. Signal Management SUN will be responsible for global safety signal management, as per international regulations, and CMS will be responsible for local safety signal management as per applicable regulatory requirements in the Territory. SUN will communicate any important identified risk with the Product(s) to CMS upon its confirmation. If CMS identifies any identified risk with the Product(s), it will promptly inform SUN and will provide reasonable further assistance in the signal evaluation, if needed. Major Safety Issues For actions relating to major safety issues (e.g. regulatory action, recall, suspension or stopping of clinical studies due to safety reasons) with the productProduct(s) covered by the agreementSDEA, SUN and CMS will inform each other immediately within TWO (2) business days. Each party will arrange to have ready access, at all times, to detailed distribution information on the product(s), in order to facilitate recalls/withdrawals, if this should become necessary. Any public statement, if required, shall be issued at the discretion ...
