Adverse Drug Experience Report definition

Adverse Drug Experience Report means any oral, written or electronic report of any Adverse Drug Experience transmitted to any Person.
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Adverse Drug Experience Report means any oral, written or electronically transmitted report of any "adverse drug experience" as defined or contemplated by 21 C.F.R. 314.80 or 312.32 or their local equivalents, associated with the use of Atorvastatin or any Product.
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Adverse Drug Experience Report means any oral, written or electronically transmitted report of any "adverse drug experience" (as defined in the FD&C Act, including, but not limited to, 21 C.F.R. 314.80 or 312.32), associated with the use of doxazosin mesylate (including the Product).
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Examples of Adverse Drug Experience Report in a sentence

  • See Office of Epidemiology and Biostatistics, Food andDrug Administration, Annual Adverse Drug Experience Report: 1996 (Oct.

  • Premarketing reportPost-marketing report • PeriodicBenefitRiskEvaluation Report (PBRER).• Periodic Safety Update Report (PSUR).• Periodic Adverse Drug Experience Report (PADER).• Development Safety Update Report.

  • Exeltis, Periodic Adverse Drug Experience Report for Benznidazole Tablet, Dec/18/2018months after the commercial launch of benznidazole (Table 3).

  • Submit all cases of hepatotoxicity as 15-day Alert reports (as described under 21 CFR 314.80(c)(1)), and provide detailed analyses of events of hepatotoxicity reported from clinical studies and post-marketing reports in your periodic safety report (i.e., the Periodic Adverse Drug Experience Report [PADER] required under 21 CFR 314.80(c)(2) or the ICH E2C Periodic Benefit-Risk Evaluation Report [PBRER] format).

  • The post approval aggregate report is Periodic Benefit Risk Evaluation Report (PBRER), Periodic Adverse Drug Experience Report (PADER), and Periodic Safety Update Report (PSUR).

  • Morphabond Periodic Adverse Drug Experience Report 04- 03-16 to 07-02-16 (Q3).

  • We request that for a period of 5 years from the U.S. approval date, you provide detailed analyses of events of blood disorders and hepatic adverse events reported from clinical study and post-marketing reports in your periodic safety report (i.e., the Periodic Adverse Drug Experience Report [PADER] required under 21 CFR 314.80(c)(2) or the ICH E2C Periodic Benefit-Risk Evaluation Report [PBRER]format).

  • We acknowledge receipt of your submission dated May 24, 2007 and to the related Addendum 1 to the Periodic Adverse Drug Experience Report 2007, dated May 24, 2007.

  • This joint decline pointed to a stronger deceleration in the pace of underlying monetary expansion than before.

  • Approximately 15 minutes into shift, he reviewed Tank 121 levels and determined the changes (about 1 m³) were within the accuracy of the measurement device (SAAB radar accuracy ± 1 m³).• 05:47, 24 January - the fourth creep alarm was received.


More Definitions of Adverse Drug Experience Report

Adverse Drug Experience Report means any oral, written or electronic report of any Adverse Drug Experience transmitted to any Party.
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Adverse Drug Experience Report means any oral, written or electronically transmitted report of any "adverse drug experience" as defined by 21 C.F.R. 314.80, associated with the use of the Product, and the term "Serious Adverse Drug Experience Report" shall mean any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
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Related to Adverse Drug Experience Report

  • Adverse Drug Experience means any of: an “adverse drug experience,” a “life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80.

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Adverse Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Peer-reviewed medical literature means a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed for scientific accuracy, validity and reliability by unbiased independent experts, and that has been determined by the international committee of medical journal editors to have met the uniform requirements for manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Independent Engineering Report means a report, in form and substance satisfactory to the Administrative Agent and each of the Lenders, prepared by an Independent Engineer, addressed to the Administrative Agent and the Lenders with respect to the Oil and Gas Properties owned by the Borrower or its Subsidiaries (or to be acquired by the Borrower or any of its Subsidiaries, as applicable) which are or are to be included in the Borrowing Base, which report shall (a) specify the location, quantity, and type of the estimated Proven Reserves attributable to such Oil and Gas Properties, (b) contain a projection of the rate of production of such Oil and Gas Properties, (c) contain an estimate of the net operating revenues to be derived from the production and sale of Hydrocarbons from such Proven Reserves based on product price and cost escalation assumptions specified by the Administrative Agent and the Lenders, and (d) contain such other information as is customarily obtained from and provided in such reports or is otherwise reasonably requested by the Administrative Agent or any Lender.

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Evaluation Report means a report on the evaluation of tenders prepared under CSO 12

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

  • clinical evidence means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Engineering Report means either an Independent Engineering Report or an Internal Engineering Report.

  • Progress Report means the report similar in form and content to that attached hereto as Appendix III.

  • FDA means the United States Food and Drug Administration.