Unexpected Adverse Event definition
Unexpected Adverse Event means an Adverse Event, the specificity or severity of which is not consistent with the current package insert or investigator’s brochure for the Licensed Product. An Unexpected Adverse Event includes any event that may be symptomatically and pathophysiologically related to an event listed in the current package insert or investigator’s brochure, but differs from the listed event because of greater severity or specificity.
Unexpected Adverse Event means each of the following (a) an adverse drug experience that is not (i) consistent with the applicable product information (e.g., the Investigator brochure), (ii) listed at the specificity or severity that has been observed, or (iii) consistent with the risk information in the general investigational plan; (b) any other unanticipated problem associated with a Product Candidate that relates to the rights, safety, or welfare of subjects participating in a Clinical Trial; (c) an “unexpected adverse event or unexpected suspected adverse reaction,” as defined 21 C.F.R. Part 312.32(a); and (d) an “unexpected adverse reaction,” as defined in Article 2(p) of EU Directive 2001/20/EC.
Unexpected Adverse Event means any adverse experience that is not listed in the current labeling for the biological product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differ from the event because of greater severity or specificity. “Unexpected”, as used in this definition, refers to an adverse experience that has not been previously observed rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product.
Examples of Unexpected Adverse Event in a sentence
Any notification made by telephone or email shall be confirmed in writing within forty-eight (48) hours, which confirmation shall contain a detailed summary of the Serious and Unexpected Adverse Event.
Provide an Unexpected Adverse Event report to the ACEC as soon as practicable following such events.
Sajo shall notify Blake (i) of any Adverse Event, Serious Adverse Event or Unexpected Adverse Event (as defined at 21 CFR § 312.32(a)) arising from the Studies, within twenty-four (24) hours after Sajo receives information about the event, to be confirmed in writing within two (2) business days and (ii) immediately in writing to Blake.
More Definitions of Unexpected Adverse Event
Unexpected Adverse Event or “Unexpected Suspected Adverse Reaction” means the definition as stated in the Protocol or an adverse event or suspected adverse reaction which is considered “unexpected” because it is not listed in the Investigator Brochure or is not listed at the specificity or severity that has been observed; or, when an Investigator Brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. Unexpected Adverse Event and Unexpected Suspected Adverse Reaction are further defined in 21 C.F.R. 312.32.
Unexpected Adverse Event means any adverse event, the nature, severity or frequency of which is not consistent with information in the most current investigator’s brochure, or with respect to a marketed product the most current SPC or package insert.
Unexpected Adverse Event means each of the following (a) an adverse drug experience that is not (i) consistent with the applicable product information (e.g., the Investigator brochure); (ii) listed at the specificity or severity that has been observed; or (iii) consistent with the risk information in the general investigational plan; (b) any other unanticipated problem associated with a Product Candidate that relates to the rights, safety, or welfare of subjects participating in a Clinical Trial; (c) an “unexpected adverse event or unexpected suspected adverse reaction,” as defined in 21 C.F.R. Part 312.32(a); and (d) an “unexpected adverse reaction,” as defined in Article 2(p) of EU Directive 2001/20/EC and Article 2.2(34) of Regulation (EU) No 536/2014.
Unexpected Adverse Event or “Unexpected Suspected Adverse Reaction” means an AE or SAR which is considered “unexpected” because it is not listed in the Investigator Brochure or is not listed at the specificity or severity that has been observed; or, when an Investigator Brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. Unexpected Adverse Event and Unexpected Suspected Adverse Reaction are further defined in 21 C.F.R. § 312.32.
Unexpected Adverse Event means the definition as stated in the Protocol.”]