Adverse Event Report definition

Adverse Event Report shall have the meaning provided in the Collaboration Agreement.
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Adverse Event Report means the written report to the appropriate Regulatory Authority from a device manufacturer required whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices: (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
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Adverse Event Report means any oral, written or electronically transmitted report of any Adverse Event.
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Examples of Adverse Event Report in a sentence

  • If the Supplier files FDA or other foreign Adverse Event Report, Correction and Removal / Field Safety Corrective Action Report, or initiates any form of field corrective activity, Supplier shall provide Mevion with copies of the reports and any Corrective Action documentation.

  • Simbec will notify Company of each serious or unexpected adverse event within 24 hours of its knowledge of the event using the Serious Adverse Event Report form provided by the Company.

  • The Serious Adverse Event Report Form and if applicable, a copy of redacted source documents (such as hospital discharge summary, medical records, etc.) related to the SAE will be sent as: • e-mail to: ▇▇▇▇▇▇@▇▇▇▇.▇▇▇; or • fax to: +▇ (▇▇▇) ▇▇▇-▇▇▇▇ The Investigator will assess whether the event is causally related to the investigational product.

  • A complete and accurate copy of all Adverse Event Report Forms referenced in such index have been previously provided to Parent.

  • BI PHARMA KG shall notify COUL▇▇▇ ▇▇▇ediately by telephone and not later than 5 (five) working days in writing after receipt by BI PHARMA KG's quality assurance department of any and all complaints, adverse reaction reports, safety issues or toxicity issues relating to Product (each an "Adverse Event Report"), regardless of the origin of such information, BI PHARMA KG shall advise COUL▇▇▇ ▇▇ such Adverse Event Report.

  • Within 24 hours of learning of the pregnancy, the investigator should complete a Serious Adverse Event Report eCRF.

  • APPENDIXES: The following appendixes are part of the Agreement: APPENDIX A: Protocol (Patient Treatment Plan); APPENDIX B: Investigator's Brochure (or IPP); APPENDIX C: Adverse Event Report.

  • Prior to any settlement of the BSN Litigation, the CE2 Claims, the Iovate Litigation, the ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Claims, and/or the Adverse Event Report Claims, the Sellers shall obtain the written consent of the Buyer to the proposed terms of any settlement which consent shall not be unreasonably withheld, delayed or conditioned.

  • Notification will include a completed Adverse Event Report Form attached hereto as Schedule 5 and any additional documents provided by the reporter.

  • Institution will report SAEs using one of the following: (i) a reporting form approved by the local regulatory authority, (ii) a CIOMS form, (iii) a Pfizer provided Investigator Sponsored Research or Clinical Research Collaboration Non-Interventional Serious Adverse Event Report Form, or (iv) any other form prospectively approved by Pfizer.


More Definitions of Adverse Event Report

Adverse Event Report. (also termed "Adverse Drug Experience Report") means any oral, written or electronically transmitted report of any Adverse Event or Adverse Drug Experience.
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Adverse Event Report means the MedWatch Report (with CAERS #92818) received from the Department of Health and Human Services of the US Food and Drug Administration.
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Adverse Event Report means a report relating to any “adverse event”, as used in 21 C.F.R. § 803.50 et seq., concerning the Pinnacle Hip System, including reports received by Defendants and reports submitted by Defendants to the FDA.
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Related to Adverse Event Report

  • 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.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • 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.

  • Incident Report means a written report of any injury, accident, acts of physical aggression, or unusual incident involving an individual.

  • MI Report means a report containing Management Information submitted to the Authority in accordance with Framework Schedule 9 (Management Information);