Exchange of Safety Reports Sample Clauses

Exchange of Safety Reports. Distributor agrees to provide Principal with all relevant safety information received by Distributor in relation to any Principal Product(s), including both initial and follow-up reports, from any source within one (1) business day of becoming aware of the information. Applicable individual case safety reports (ICSRs) include but are not limited to the following: • Adverse Events from any source. • “Special situation” events: drug exposure including pregnancy/breast feeding, occupational exposure, off-label use, overdose, medication errors, misuse/abuse, lack of therapeutic effect, possible drug interaction, unintended beneficial effects, transmission via an infectious agent o These situations should be reported to Principal regardless of whether or not there is an associated adverse event. Potential sources of safety information may include but are not limited to: • Clinical trials • Health care professionals or consumers • Product quality complaint • Medical information enquiry • Local media e.g. newspaper, internet or radio • Patient support programs • Local Literature • Local Pharmacovigilance website or database* *Distributor will be responsible for the screening ICSRs associated with the Product from the local pharmacovigilance website/database if requested by the local authority and will exchange the ICSRs with the Principal as per Section 7 of SDEA. To be considered as a Valid Case, an AE or “special situation” report must include all the following: • One or more identifiable reporting source • One single identifiable patient characterised by initials, patient identification number, date of birth, age, age group or gender. • One or more (Principal) suspected medicinal products • One or more suspected adverse event or “special situation”. Every effort should be made by the Distributor to obtain the minimum criteria above. However, if this is not possible, the Distributor should send whatever information is available to Principal by the Safety Contacts (see Schedule 1) within one (1) business day. For the purposes of the SDEA, all Valid and Invalid Cases shall be exchanged providing the information is related to TopRidge Adverse Event Reporting Form 1. 0 version or TopRidge Pregnancy Outcome Report Form Version 1.0 (Schedule 2) to Principal according to Table 1. Table 1 SAFETY REPORT TYPE FORMAT METHOD OF TRANSFER TIMELINE All AEs/ADRs and Special Reports (serious and non- serious) Principal’s AE Form Email/ (see Contact information Schedule 1) one (...
Sample 1
AutoNDA by SimpleDocs

Related to Exchange of Safety Reports

  • DISASTER OR EMERGENCY REPORTS Any disaster or emergency situation, natural or man-made, such as fire or severe weather, shall be reported telephonically within 72 hours, followed by a comprehensive written report within seven days to DHA.

  • SAFETY REGULATIONS Equipment shall meet all State and Federal safety regulations.

  • Data and Reports The School is consistent in providing information, data, documentation, evindence and reports requested by the Commission pursuant to HRS §302D-17. x Review of submissions.

  • MATERIAL SAFETY DATA SHEETS Contractor is required to ensure Material Safety Data Sheets (“MSDS”) are available, employees are trained in the use of MSDS, and MSDS are in a readily accessible place at the Site. This requirement applies to all materials with an associated MSDS per the federal “Hazard Communication” standard or employees’ Right-to-Know laws. Contractor is also required to ensure proper labeling and training on any substance brought onto the Site and that any person working with the material (or who is subject to possible exposure by use of the material or contact with the material), is informed of the possible and/or real hazards of the substance, and follows proper handling and protection procedures.

  • Material Safety Data Sheet Seller shall provide to Buyer with each delivery any Material Safety Data Sheet applicable to the work in conformance with and containing such information as required by the Occupational Safety and Health Act of 1970 and regulations promulgated thereunder or its State approved counterpart.

  • INFORMATION AND APPLICATIONS POLICY LANGUAGE For State Agency Authorized User Acquisitions: Any web-based information and applications development, or programming delivered pursuant to the contract or procurement, will comply with New York State Enterprise IT Policy NYS-P08-005, Accessibility of Web-Based Information and Applications as follows: Any web-based information and applications development, or programming delivered pursuant to the contract or procurement, will comply with New York State Enterprise IT Policy NYS-P08-005, Accessibility of Web-Based Information and Applications as such policy may be amended, modified or superseded, which requires that state agency web-based information and applications are accessible to persons with disabilities. Web-based information and applications must conform to New York State Enterprise IT Policy NYS-P08-005 as determined by quality assurance testing. Such quality assurance testing will be conducted by the State Agency Authorized User and the results of such testing must be satisfactory to the Authorized User before web-based information and applications will be considered a qualified deliverable under the contract or procurement.

  • Accident Reports If any of the Equipment is damaged, lost stolen, or destroyed, or if any person is injured or dies, or if any property is damaged as a result of its use, maintenance, or possession, You will promptly notify Us of the occurrence, and will file all necessary accident reports, including those required by law and those required applicable insurers. You, Your employees, and agents will cooperate fully with Us and all insurers providing insurance under this Agreement in the investigation and defense of any claims. You will promptly deliver to Us any documents served or delivered to You, Your employees, or Your agents in connection with any claim or proceeding at law or in equity begun or threatened against You, Us, or both You and Us.

  • Information and Reports The contractor will provide all information and reports required by the Acts, the Regulations, and directives issued pursuant thereto and will permit access to its books, records, accounts, other sources of information, and its facilities as may be determined by the sponsor or the Federal Aviation Administration to be pertinent to ascertain compliance with such Nondiscrimination Acts And Authorities and instructions. Where any information required of a contractor is in the exclusive possession of another who fails or refuses to furnish the information, the contractor will so certify to the sponsor or the Federal Aviation Administration, as appropriate, and will set forth what efforts it has made to obtain the information.

  • New Hampshire Specific Data Security Requirements The Provider agrees to the following privacy and security standards from “the Minimum Standards for Privacy and Security of Student and Employee Data” from the New Hampshire Department of Education. Specifically, the Provider agrees to:

  • Rectification of Safety Hazard 60.12 Where, because of the existence of a safety hazard, a site has been stopped for a defined period of time and Employees sent off site by agreement between Site Managers and any combination of Union Official/s, Health and Safety Committee, those people who remain on site to do rectification work will be paid at the rate of double time for all such work.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!