Adverse Event Reporting definition

Adverse Event Reporting means the procedure relating to drug safety and/or pharmacovigilance concerning Products as separately agreed upon between the Parties.
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Examples of Adverse Event Reporting in a sentence

  • These include: o Training on the DSHS system for documenting vaccine encounters during the event o Training on the DSHS system for collecting ImmTrac2 consent forms o Training on the DSHS Data Logger you will be issued on the event day by the COVID-19 Vaccine Storage Facility o Training on the Vaccine Adverse Event Reporting System (VAERS) o Training on How to Prepare All Physical Event Paperwork for Submission to the Appropriate Texas Public Health Entity.

  • During the Exclusive Period, either Party shall promptly report to the other Party any information regarding adverse events related to the use of the Product in accordance with the Adverse Event Reporting Procedures (as may be amended from time to time upon mutual agreement) set forth as Exhibit E and incorporated herein by reference.

  • Pharmacist must report adverse events to the Vaccine Adverse Event Reporting System (VAERS) within seventy-two (72) hours of the adverse event.

  • From time to time after the Effective Date, representatives from both Parties shall meet to review and revise or replace such Adverse Event Reporting and pharmacovigilance procedures.

  • To the extent Trubion has or receives any information regarding any adverse drug experience which may be related to the use of any Licensed Product or to Licensed Product Development, Trubion shall promptly provide Wyeth with all such information in accordance with the Adverse Event Reporting and pharmacovigilance procedures set forth in Exhibit 4.4 attached hereto (as may be amended from time to time upon written mutual agreement of the Parties).

  • D-1 Exhibit E Adverse Event Reporting Procedures ...................................

  • The Parties agree to use commercially reasonable efforts to reach agreement on Adverse Event Reporting Procedures which will be set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from Purchaser to Supplier, the “Adverse Event Reporting Procedures”) at least three (3) months prior to Launch but shall reach such agreement no later than one (1) month prior to Launch.

  • Each Party shall fully, accurately and promptly provide to the other Party with all data known to it at any time during the term of this Agreement or thereafter, which data indicate that any Product marketed by WCH is or may be unsafe, lacks utility, or otherwise does not meet Specifications in accordance with the Adverse Event Reporting Procedures set forth in Exhibit D attached hereto (as the same may be amended from time to time by notice in writing from WCH to IMPAX).

  • The process and responsibilities for such reports will be governed by the Adverse Event Reporting Addendum separately agreed to by the Parties.

  • FDA’s Guidance on Adverse Event Reporting to Institutional Review Boards in Clinical Trials (January 2009) may be used in meeting this requirement The provisions of this Section shall survive for two years after termination of this Agreement.

Related to Adverse Event Reporting

  • Adverse Event means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Licensed Product, whether or not having a causal relationship with such Licensed Product, including, without limitation, any unfavorable and unintended sign (including, without limitation, abnormal laboratory findings of clinical concern), symptom or disease temporally associated with the use of such Licensed Product.

  • 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.

  • Day reporting means a program of enhanced supervision

  • 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.

  • Rapid(ly) report(ing) means within 72 hours of discovery of any cyber incident.