Safety Information definition
Safety Information means (a) any Adverse Event, including any Adverse Event related to a quality defect or received through a medical information inquiry, or (b) any Adverse Event related to a report of falsified or counterfeit medicinal product or (c) any of the following with or without an associated Adverse Event:
Safety Information. The Contractor assumes full responsibility for the safety of his employees, equipment and supplies. USE OF THE IDAHO DEPARTMENT OF LANDS NAME: Contractor agrees that it will not, prior to, in the course of, or after performance under this contract, use IDL's name in any advertising or promotional media as a customer or client of Contractor without the prior written consent of IDL. PUBLIC RECORDS: Pursuant to Idaho Code Section 74-101 through 74-126, information or documents received from the Contractor may be open to public inspection and copying unless exempt from disclosure. The Contractor shall clearly designate individual documents as “exempt” on each page of such documents and shall indicate the basis for such exemption. IDL will not accept the marking of an entire document as exempt. In addition, IDL will not accept a legend or statement on one (1) page that all, or substantially all, of the document is exempt from disclosure. The Contractor shall indemnify and defend IDL against all liability, claims, damages, losses, expenses, actions, attorney fees and suits whatsoever for honoring such a designation or for the Contractor’s failure to designate individual documents as exempt. The Contractor’s failure to designate as exempt any document or portion of a document that is released by IDL shall constitute a complete waiver of any and all claims for damages caused by any such release. If IDL receives a request for materials claimed exempt by the Contractor, the Contractor shall provide the legal defense for such claim.
Safety Information means any information relating to:
(a) the death, serious injury or illness of a person that may have been caused by the use or misuse of the Purchaser’s product (a serious injury or illness includes any acute physical injury or illness requiring medical or surgical treatment by, or under the supervision of, a qualified doctor or nurse); or
(b) human health and/or wellbeing arising following exposure of humans to the Supplier’s products such as Adverse Event information, including: any unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated); reports of patients taking drugs whilst pregnant or breastfeeding; drug abuse or drug withdrawal; medication errors or misuse, including drug overdose, whether accidental or intentional; information received as part of product complaints; failure to produce expected benefits (i.e. lack of efficacy); reports of occupational exposure; reports of drug interaction; reports of paternal exposure to a GSK Product; transmission of an infectious agent via a medicinal product and information regarding unexpected therapeutic benefits such as unexpected improvement in a concurrent condition other than the one being treated;
Examples of Safety Information in a sentence
Within [***] after the Effective Date, the Parties shall enter into one (1) or more pharmacovigilance agreement(s) (“Pharmacovigilance Agreement”), which shall set forth the Parties’ respective obligations surrounding pharmacovigilance for the Licensed Compounds and Licensed Products, including the exchange of Safety Information and reporting obligations to Regulatory Authorities in accordance with Applicable Law and the maintenance and control of the global safety database.
In the event Vir Bio conducts any Clinical Study pursuant to Section 7.9.4(c), and at any time Licensee desires to obtain rights to use or reference the data from such Clinical Study in the Territory, excluding any Safety Information Vir Bio is required to provide to Licensee pursuant to the applicable Pharmacovigilance Agreement or Section 3.6.2 (the “Unilateral Study Data”), Licensee shall provide written notice thereof to Vir Bio.
Licensee shall be responsible for reporting Safety Information in the Territory with respect to the applicable Licensed Product(s) in conformance with Applicable Law; and Vir Bio shall have corresponding obligations with respect to the Licensed Product(s) in the Vir Bio Territory.
More Definitions of Safety Information
Safety Information has the meaning set forth in Section 9.5.
Safety Information means (a) any Adverse Event, including any Adverse Event related to a quality defect or received through a medical information inquiry, or (b) any Adverse Event related to a report of falsified or counterfeit medicinal product or (c) any of the following with or without an associated Adverse Event: (i) any unspecified event of death, (ii) drug exposure during lactation, (iii) drug exposure during pregnancy or at the time of conception (maternal or paternal), (iv) lack of therapeutic efficacy, (v) overdose, (vi) misuse, (vii) abuse, (viii) medication error potential, intercepted or actual, (ix) unintended beneficial effects, (x) occupational exposure, (xi) off label use, or (xii) suspected transmission of an infectious agent. „Bezpečnostní informace“ znamená (a) jakýkoliv Nežádoucí účinek, včetně jakéhokoliv Nežádoucího účinku souvisejícího s vadou jakosti nebo získaného prostřednictvím dotazů na lékařské informace, nebo (b) jakýkoliv Nežádoucí účinek související s hlášením o padělaném nebo nepravém léčivém přípravku nebo (c) jakoukoliv z následujících skutečností s nebo bez souvisejícího Nežádoucího účinku: (i) jakoukoliv nespecifikovanou událost úmrtí, (ii) vystavení léku v průběhu kojení, (iii) vystavení léku v průběhu těhotenství nebo v době početí (ze strany matky nebo otce), (iv) nedostatek terapeutického účinku, (v) předávkování, (vi) nesprávné použití, (vii) zneužití, (viii) chybový potenciál medikace, zachycený nebo skutečný, (ix) neúmyslné prospěšné účinky, (x) expozice při zaměstnání, (xi) použití neuvedené na štítku, nebo (xii) podezření na přenos infekčního činitele.
Safety Information means (a) any Adverse Event, including any Adverse Event related to a quality defect or received through a medical information inquiry, or (b) any Adverse Event
Safety Information means all serious and unexpected suspected adverse reactions (SUSARs), Serious Adverse Events, Serious Adverse Drug Reactions, and other clinically relevant adverse events, safety and toxicity findings, in each case, with respect to a Compound (whether administered alone or in combination with other pharmaceutical agents).
Safety Information means information contained in safety data collection and processing systems established for the sole purpose of improving aviation safety and qualified to be protected under specified conditions;
Safety Information means (a) any Adverse Event, including any Adverse Event related to a quality defect or received through a medical information inquiry, or (b) any Adverse Event related to a report of falsified or counterfeit medicinal product or (c) any of the following with or without an associated Adverse Event: (i) any unspecified event of death, (ii) drug exposure during lactation, (iii) drug exposure during pregnancy or at the time of conception (maternal or paternal), (iv) lack of therapeutic efficacy, (v) overdose, (vi) misuse, (vii) abuse, (viii) medication error - potential, intercepted or actual, (ix) unintended beneficial effects, (x) occupational
Safety Information means all filings, submissions and reports concerning the safety of the Investigational Medicinal Product or Pharmacovigilance with or to any Regulatory Authority or Ethics Committee, or a body designated or recognized by any Regulatory Authority or Ethics Committee for such purposes.