Expedited Reporting Sample Clauses
The Expedited Reporting clause requires parties to promptly notify each other of certain significant events or developments, often within a shortened or specifically defined timeframe. This typically applies to situations such as adverse events, breaches, or regulatory issues, where rapid communication is critical. By mandating swift disclosure, the clause ensures that all parties can respond quickly to urgent matters, thereby minimizing risks and facilitating timely decision-making.
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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. 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.
1.2 The same time frames apply to the follow-up reports. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.3 The Licensee will report to its Authorities all Serious Adverse Drug Reactions occurring in the DUSA Territory regarding the Product, and will send copies to the Licensor.
1.4 The Licensor will report to the Licensee all Serious Adverse Drug Reactions occurring in the Photonamic Territory and [ * ] regarding any other Photonamic medicines containing the same active compound as the Product when transmitted by Photonamic's Licensees, for purposes of information.
1.5 The Licensor will send to the Licensee copies of all reports of Serious Adverse Drug Reactions (expected and unexpected) occurring outside the European Union regarding any other Photonamic medicines containing the same active compound as the Product. The Licensee will report the Unexpected Serious Adverse Drug Reactions to its Authorities, using medac's case number.
1.6 Each party shall ensure parallel reporting to the Regulatory Authorities of all local and foreign expedited reports in their respective countries in which a marketing authorization or a marketing license is granted, according to the requirements of the applicable laws and regulations in such countries.
1.7 Expedited reporting between the parties shall be conducted according to the definitions of The Rules Governing Medicinal Products in the European Union Volume 9 - Pharmacovigilance; provided, however, that if a Regulatory Authority has a requirement which is stricter than the requirements of The Rules Governing Medicinal Products in the European Union Volume 9 - Pharmacovigilance, the parties will comply with such stricter requirement. The parties shall promptly inform each other in writing about such stricter requirements applicable in their respective territory, especially after the requirements have been changed.
1.8 Both parties have agreed upon the format of the suspected Adverse Drug Reaction report and an e-mail or fax transmission mode.
1.9 The safety reference Product Information used for determining the labeling of a reaction is the current version of the Su...
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. 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. 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. 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. 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 of SUN. SUN will have the responsibility of maintaining and updating Product label (P...
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 Sponsor will report all relevant information about SUSARs that are fatal or life-threatening as soon as possible to the FDA and in any case no later than 7 days after knowledge by the Sponsor/designee of such a case, and the relevant follow-up information will subsequently be communicated within an additional 8 days. All other SUSARs will be reported to the FDA as soon as possible but within a maximum of 15 days of first knowledge by the Sponsor/designee. The Sponsor/designee will also inform all Investigators as required.
Expedited Reporting