Adverse Events definition

Adverse Events means any serious or unexpected side effect, injury, toxicity, or sensitivity reaction, or any adverse drug reaction reports and the severity thereof associated with the Product where the term “serious” as used in this Section refers to an experience which results in death, permanent or substantial disability, a vegetative state, inpatient hospitalization or prolongation of hospitalization, a congenital anomaly, cancer, an overdose, or is life threatening. The term “unexpected” as used in this definition means an adverse drug experience that is not listed in the then current labeling for the Product and includes an event that may be symptomatically or pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity.

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Adverse Events 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 a product in humans, occurring at any dose, whether expected or unexpected and whether or not considered related to or caused by a product, including such an event or experience as occurs in the course of the use of a 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 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 Regulatory Authorities under corresponding applicable Law outside the United States.

Adverse Events means any untoward medical occurrence in a patient or clinical investigation subject who is administered a medicinal product, which occurrence may have, but does not necessarily have to have, a causal relationship with the medicinal product, including any occurrence designated as an adverse event under 21 C.F.R. 312.32 and any other Applicable Laws.

Examples of Adverse Events in a sentence

• Such information will include the Investigator's Brochure (IB) and information on Suspected Unexpected Serious Adverse Events (SUSARs) for unlicensed products or the Summary of Product Characteristics (SPC) for licensed products.

• Such agreement shall describe the coordination of collection, investigation, reporting, and exchange of information concerning Adverse Events or any other safety problem of any significance, and product quality and product complaints involving Adverse Events, sufficient to permit each Party, its Affiliates, licensees or sublicensees to comply with its legal obligations.

• The Parties shall co-operate with regard to the reporting and handling of Adverse Events in accordance with the applicable regulatory laws and regulations on pharmacovigilance.

• There have not been any Material Adverse Events with respect to the Products or the Business.

• The clinical activities conducted by PPD, including but not limited to the collection, evaluation and reporting of Adverse Events, shall be in accordance with ICH guidance, meeting GCP standards and in compliance with applicable laws and regulations.

More Definitions of Adverse Events

Adverse Events has the meaning ascribed to it in Section 3.8.

Adverse Events means any undesirable event or reaction reported to or known by the Parties regarding the Labeled Drug that is determined to be potentially associated with the use of the Labeled Drug in humans.

Adverse Events means those events as defined by the FDA and published in the U. S. Code of Federal Regulations, as amended from time to time and published in the Federal Register, or by the PMDA or any similar definitions under laws within the License Territory relating to adverse drug experiences relating to the use of the Product in the License Territory.

Adverse Events shall have the meaning set out in Section 3.11.

Adverse Events shall have the meaning set forth in Section 4.10 hereof.

Adverse Events has the meaning set forth in Section 9.2(o).

Adverse Events means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, and “Serious Adverse Events” is an Adverse Event that is considered “serious”, because, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, a life-threatening Adverse Event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or a congenital anomaly/birth defect.