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PSUR line listing template PSUR Line listing for suspected adverse events in animals VETERINARY PHARMACOVIGILANCE SCHEME PERIODIC SAFETY UPDATE REPORT MARKETING AUTHORISATION HOLDER FORM FOR REPORTS OF ANIMAL ADVERSE EVENTS TO A VETERINARY MEDICINAL PRODUCT PRODUCT PERIOD OF REPORT FROM. /. /. MAH CASE REF CA CASE REF DATE OF TREATMENT/ VACCINATION EVENT NO. TREATED SPECIES AND AGE JUV/ADULT TO. /. /. a DIED b USED AS RECOMMENDED YES/NO OTHER PRODUCTS USED CONCURRENTLY VeDDRA PRESENTING SIGNS/ DIAGNOSIS Please ensure that this total is put in EEA REPORTS Country Code Organisation ID Case Number Ref Name Country BRIEF INFORMATIVE NARRATIVE AND MAH CONCLUSIONS CAUSALITY ABON CODE Please ensure these sections are completed OVERALL TOTAL OF ALL EEA PAGES Total no. of reports Total no. of animal reactions a THIRD COUNTRY FOR COMPETENT AUTHORITY USE ONLY REFERENCE VOLUME 9B Annexes 349758 DATE OF RECEIPT 140/165 HUMAN CA CASE NAME S OR UNIQUE PATIENT S IDENTIFICATION OCCUPATION EXPOSURE NATU....

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Direct healthcare professional communications. European Risk Management Strategy. Good pharmacovigilance practices. Incident management plan. Medical literature monitoring. Medication errors. Medicines under additional monitoring. Periodic safety update reports (PSURs) Guidance.

While the content of a PSUR can vary, depending on the amount of specific data the vendor chooses to include, the PSUR should, at a minimum, always include: an executive summary, safety conclusions and benefit-risk determination, main findings of the Post Market Clinical Follow-up (PMCF) [or Post Market Performance ...

PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation.

Contents of the PSUR General information. ... History of changes. ... Surveillance results (including clinical follow-up) ... Vigilance results. ... Trend analysis. ... Identification and verification of signals. ... Benefit/risk analysis. ... PSUR conclusion.

What is the Periodic Safety Update Report (PSUR)? The Periodic Safety Update Report (PSUR) is described as a pharmacovigilance document that is intended to provide an evaluation of the risk-benefit balance of medicinal products at defined time points after their authorization.

A PSUR should contain all the present available information of the product in addition to emerging information. The report must present all the relevant data of the risk and benefits associated with the product along with its impact on the market authorization.

Top 10 Tips for Writing PSURs and PMS Reports Keep the goal top of mind. ... Align your report with your PMS plan. ... Identify and gather source data. ... Meet the minimum data requirements outlined in the regulation. ... Perform data analysis. ... Reference previous PSURs/PMS reports. ... Review literature on a regular basis.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232