appendix-1-pharmacovigilance-inspection-report-template-vet_en.doc - Insert lead inspector’s competent authority logo emblem PHARMACOVIGILANCE

Appendix-1-pharmacovigilance-inspection-report-template-vet_en.doc

This preview shows page 1 - 5 out of 16 pages.

Insert lead inspector’s competent authority logo / emblem PHARMACOVIGILANCE INSPECTION REPORT Pharmacovigilance system name: Company Name: Inspection number: INS/PHV/XXXX/XXX [Enter EMA inspection reference number and/or NCA inspection reference as applicable] [Delete guidance notes and other non-applicable parts of this document before finalising] Version number: Date of issuance:
Image of page 1
Table of contents Abbreviations 3 SECTION A: Administrative information 4 SECTION B: General information 5 B.1. Scope and reason for the inspection ........................................................................................ 5 B.2. Reference texts and documents for the inspection ................................................................... 5 B.3. Conduct of the inspection with summary of the organisation and any significant changes and action taken since last inspection ........................................................................................................ 5 SECTION C: Inspected items 6 SECTION D: Findings 6 D.1. Definitions of inspection finding grading .................................................................................. 6 D.2. Guidance for responding to inspection findings ........................................................................ 6 D.3. Inspection findings ................................................................................................................... 7 D.3.1. Critical findings ..................................................................................................................... 7 D.3.2. Major findings ....................................................................................................................... 8 D.3.3. Minor findings ....................................................................................................................... 8 D.3.4. Comments / Recommendations ............................................................................................ 9 SECTION E: 9 E.1 Conclusions 9 E.2 Recommendations 9 E.3 Evaluation by the inspectors of the response from the inspectee 9 E.4 Final conclusions and recommendations 9 SECTION F: Date and signatures of lead and other inspectors, experts if applicable 9 APPENDIX I - Summary of items inspected - optional 10 APPENDIX II - Pharmacovigilance inspection plan 15 APPENDIX III - Closing meeting attendance record 16 Page 2/16
Image of page 2
Abbreviations ADR Adverse Drug Reaction / Adverse Reaction AE/AER Adverse Event / Adverse Event Report CA Competent Authority CAPA Corrective Action Preventive Action CVMP Committee for Medicinal Products for Veterinary Use CRO Contract Research Organisation CSR Clinical Study Report CSU Central Safety Unit EMA European Medicines Agency ICH International Conference on Harmonisation ICSR Individual Case Safety Report IR Inspection Report MAH Marketing Authorization Holder PhV/PV Pharmacovigilance PSUR Periodic Safety Updates Report QA Quality Assurance QPPV Qualified Person for Pharmacovigilance RA Regulatory Authority SAE Serious Adverse Event SAR Serious Adverse Reaction SSAR Suspected Serious Adverse Reaction SmPCs Summary of Product Characteristics SOP Standard Operating Procedure SUSAR Suspected Unexpected Serious Adverse Reaction TBA To Be Announced [Please delete or add any abbreviations, as applicable. Delete guidance notes and other non-applicable parts of this document before finalising] Page 3/16
Image of page 3
SECTION A: Administrative information Inspection type: National routine, etc Name and address(es) of site(s) inspected: Contact person: If different from QPPV Date(s) of inspection: Lead inspector if any: Reporting inspector if any: Accompanying inspector(s) and experts: Previous PhV inspections: Date and competent authority (inspectorates) Purpose of inspection: Products selected to provide system examples: As part of the general systems review, there are products chosen for close evaluation of ADR reports, PSURs, etc.
Image of page 4
Image of page 5

You've reached the end of your free preview.

Want to read all 16 pages?

  • Fall '17
  • William Heywood

What students are saying

  • Left Quote Icon

    As a current student on this bumpy collegiate pathway, I stumbled upon Course Hero, where I can find study resources for nearly all my courses, get online help from tutors 24/7, and even share my old projects, papers, and lecture notes with other students.

    Student Picture

    Kiran Temple University Fox School of Business ‘17, Course Hero Intern

  • Left Quote Icon

    I cannot even describe how much Course Hero helped me this summer. It’s truly become something I can always rely on and help me. In the end, I was not only able to survive summer classes, but I was able to thrive thanks to Course Hero.

    Student Picture

    Dana University of Pennsylvania ‘17, Course Hero Intern

  • Left Quote Icon

    The ability to access any university’s resources through Course Hero proved invaluable in my case. I was behind on Tulane coursework and actually used UCLA’s materials to help me move forward and get everything together on time.

    Student Picture

    Jill Tulane University ‘16, Course Hero Intern

Stuck? We have tutors online 24/7 who can help you get unstuck.
A+ icon
Ask Expert Tutors You can ask You can ask You can ask (will expire )
Answers in as fast as 15 minutes
A+ icon
Ask Expert Tutors