Adverse Event Experience definition

Adverse Event Experience shall have the meaning set forth in Section 9.2.
Sample 1Sample 2Sample 3
Adverse Event Experience means (a) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (b) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurring following administration, of the Licensed Product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by the Licensed Product, including such an event or experience as occurs in the course of the use of the Licensed Product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of the Licensed Product, and including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States.
Sample 1Sample 2
Adverse Event Experience means (a) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (b) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurring following administration, of a Licensed Product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by a Licensed Product, including such an event or experience as occurs in the course of the use of a Licensed Product in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of a Licensed Product, and including those events or experiences - 49 -
Sample 1

Examples of Adverse Event Experience in a sentence

  • Each Party shall investigate the Complaint and, to the extent required to be reported to any Regulatory Authority or related to any Adverse Event Experience, notify the other Party in reasonable detail of any Complaint received by it within five (5) days after the initial report of the event, and in any event in sufficient time to allow such Party to comply with all Applicable Law in any country.

  • Subject to the terms of this Agreement, within three (3) months of the Effective Date, GPC Biotech and Licensee shall discuss and develop mutually acceptable guidelines and procedures for the investigation, exchange, receipt, recordation, communication (as between the Parties) and exchange of Adverse Event Experience information and all other information regarding matters covered in this Article 9.

  • Subject to the terms of this Agreement, promptly following the commencement of the Co-Promotion Period, Licensor and Licensee shall discuss and develop mutually acceptable guidelines and procedures for the investigation, exchange, receipt, recordation, communication (as between the Parties) and exchange of Adverse Event Experience information and all other information regarding matters covered in this ARTICLE 9.

  • Subject to the terms of this Agreement, within three (3) months of the Effective Date, GPC Biotech and Yakult shall discuss and develop mutually acceptable guidelines and procedures for the investigation, exchange, receipt, recordation, communication (as between the Parties) and exchange of Adverse Event Experience information and all other information regarding matters covered in this Article 8.

  • Table 8: Overall Adverse Event Experience during the Blinded Phase (PP population)CategorySunitinib (N=202)Placebo (N=102)Patients with ≥ 1 adverse event, n (%)190 (94)Source: A6181004 trial report Treatment-related adverse events, serious adverse events, and treatment-related serious adverse events appeared to be more common on the sunitinib arm.

  • It is anticipated that such Pharmacovigilance Agreement shall include provisions for the exchange between the Parties of Adverse Event Experience reports, the creation and maintenance by Licensee of an electronic database comprised of all adverse events reported on a worldwide basis with respect to the Licensed Products and the establishment of appropriate mechanisms by which Licensor can, in a timely manner, access such database to comply with Applicable Law.


More Definitions of Adverse Event Experience

Adverse Event Experience means (i) any finding from tests in laboratory animals or in vitro that suggests a significant risk for human subjects including reports of mutagenicity, teratogenicity or carcinogenicity and (ii) any undesirable, untoward or noxious event or experience associated with the clinical, commercial or other use or occurring following administration, of the Licensed Products in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by the Licensed Products, including such an event or experience as occurs in the course of the use of the Licensed Products in professional practice, in a clinical trial, from overdose, whether accidental or intentional, from abuse, from withdrawal or from a failure of expected pharmacological or biological therapeutic action of the Licensed Products, and including those events or experiences that are required to be reported to the regulatory authorities, including the European Medicines Agency and the FDA under the respective applicable laws, subject to Exhibit 4
Sample 1
Adverse Event Experience means an adverse experience required to be reported to a Regulatory Authority, including under the Pharmaceutical Affairs Law or Applicable Law in the United States.
Sample 1
Adverse Event Experience shall have the meaning set forth in Section 9.2. 1.1.2 “Affiliate” shall mean, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common
Sample 1

Related to Adverse Event Experience

  • 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.

  • 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.

  • 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.

  • Work experience means an activity in the unpaid employment component in which the participant works without pay at a job site to develop good work habits and basic vocational skills that enhance the likelihood the participant will become employed. "Work experience" is available through private for-profit businesses, nonprofit organizations, or public agencies.¶

  • 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 reaction means an unexpected outcome that threatens the health or safety of a patient as a result of a medical service, nursing service, or health-related service provided to the patient.

  • Teaching Experience means full-time employment as a teacher in a public school, private school licensed or accredited by the State Board of Education, or institution of higher education,

  • Serious Adverse Event means any adverse event that led to any of the following:

  • 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;

  • Professional experience means the actual and lawful pursuit of the profession concerned;

  • 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.

  • 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.

  • 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.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Adverse impact on visibility means visibility impairment which interferes with the management, protection, preservation or enjoyment of the visi- tor’s visual experience of the Federal Class I area. This determination must be made on a case-by-case basis taking into account the geographic extent, in- tensity, duration, frequency and time of visibility impairment, and how these factors correlate with (1) times of vis- itor use of the Federal Class I area, and(2) the frequency and timing of natural conditions that reduce visibility.

  • Potential Material Event means any of the following: (i) the possession by the Company of material information not ripe for disclosure in the Registration Statement, which shall be evidenced by determinations in good faith by the Board of Directors of the Company that disclosure of such information in the Registration Statement would be detrimental to the business and affairs of the Company, or (ii) any material engagement or activity by the Company which would, in the good faith determination of the Board of Directors of the Company, be adversely affected by disclosure in the Registration Statement at such time, which determination shall be accompanied by a good faith determination by the Board of Directors of the Company that the Registration Statement would be materially misleading absent the inclusion of such information.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Regulatory Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • Co-occurring disorder specialist means an individual

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Unproven/ Experimental treatment means the treatment including drug experimental therapy which is not based on established medical practice in India.

  • Product Complaint means any oral, electronic or written communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a marketed product, including failure of the product, labelling or packaging to meet specifications, whether or not the product is related to or caused the alleged deficiency. A complaint may allege that an Adverse Event or Medical Device Malfunction (as defined herein) has occurred.

  • Commercial Discovery means any Discovery, which has been declared to be commercial by the Contractor;