Adverse Drug Event means any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Adverse Drug Event means any untoward medical occurrence in a patient or clinical investigation subject administered with the Product, including any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Product, whether or not considered related to the Product. Affected Obligations is defined in clause 21.1(a)(ii).
Adverse Drug Event means an injury resulting from the use of a drug.
Examples of Adverse Drug Event in a sentence
The parties agree to develop and commit to a Safety Data Exchange Agreement (“SDEA”) that allows them to fulfill their respective regulatory and pharmacovigilence obligations relating to Adverse Drug Event and Adverse Drug Reaction reporting.
More Definitions of Adverse Drug Event
Adverse Drug Event means an unexpected and undesired incident that results in patient injury or death or an adverse outcome for a patient, including injury or complication.
Adverse Drug Event means any noxious, unintended, or untoward medical occurrence in a patient or clinical investigation subject associated with the use of a medicinal or investigational product, whether or not related to the medicinal or investigational product.
Adverse Drug Event means any experience with any of the Finished Products which may adversely impact the Marketing Authorization and which shall include any unfavorable, unusual or unwanted signs, symptoms, or laboratory values (whether or not considered drug related) experienced by a patient or customer that may be attributable to the Active Pharmaceutical Ingredient.
Adverse Drug Event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related, pursuant to FDA regulation 21 CFR 312.32 and Art. 2 lit. (m) of the Directive.
Adverse Drug Event means any unwanted medical occurrence in a subject to whom a drug is administered and includes an occurrence which is not caused by or related to the drug;
Adverse Drug Event or "ADE" means an injury from a medicine or lack of an intended medicine.
Adverse Drug Event means any event involving a medication that causes or leads to patient harm, while the medication is in the control of the facility. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."