Examples of Serious Adverse Experience in a sentence
In any event, each Party shall notify the other Party within [*] of any Serious Adverse Experience (as set forth in 21 CFR 314.80).
In addition to the foregoing, the Parties shall update the current guidelines and procedures to govern receipt, processing, assessment and submission of Aldurazyme Adverse Experience and Serious Adverse Experience reports to the FDA, the European Commission and other regulatory authorities within sixty (60) days after the Effective Date.
Furthermore, upon Sponsor's reasonable request, DCR shall promptly investigate any such Serious Adverse Experience and shall submit follow-up reports of new information in a timely manner.
A Serious Adverse Experience or Event (SAE) is any AE that occurring at any dose results in any of the following outcomes: death, life-threatening adverse toxicity experience, inpatient hospitalization or prolongation of existing hospitalization (excluding hospitalization for elective procedures or transfusions), a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
The designated reporting form [Sponsor or CTCC provided Serious Adverse Experience Notification Form (SAEN) or MedWatch Form] must be completed for all Serious Adverse Experiences regardless of causality or expectedness.