PSMF

EudraVigilance registration manual

Retrieved on: 
Wednesday, April 3, 2024
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Key Points: 

    Union procedure on the preparation, conduct and reporting of EU pharmacovigilance inspections

    Retrieved on: 
    Wednesday, April 3, 2024
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    Union procedure on the preparation, conduct and

    Key Points: 
      • Union procedure on the preparation, conduct and
        reporting of EU pharmacovigilance inspections
        Table of contents
        1.
      • Record management and archiving ....................................................................... 12

        References ................................................................................................ 12
        Appendix 1 ?Pharmacovigilance inspection report .................................... 13
        Appendix 2- Inspection overview (IO) ...................................................... 14
        Appendix 3- Pharmacovigilance inspection outcome sharing .................... 15
        Appendix 4- Classification of inspection findings....................................... 16

        Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 2/16

        1.

      • Guidelines on the interpretation of legislative pharmacovigilance
        requirements are published in the adopted good pharmacovigilance practices (GVPs) Module III ?
        pharmacovigilance inspections.
      • Preparation of a risk-based programme for pharmacovigilance inspections is presented in the Union
        procedure on the coordination of EU pharmacovigilance inspections.
      • Scope
        This procedure constitutes a guideline in preparing, conducting and reporting national competent
        authority (NCA) pharmacovigilance inspections and outlines the steps taken of the Committee for
        Medicinal Products for Human Use (CHMP) requested pharmacovigilance inspections.
      • Those are covered under the Union procedure on the
        management of pharmacovigilance inspection findings which may impact the robustness of the benefitrisk profile of the concerned medicinal products.
      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 3/16

        3.

      • Preparation
        Preparation encompasses those activities undertaken after the selection of an MAH, or third party, for
        a pharmacovigilance inspection and prior to inspection conduct.
      • For the selection of involved
        parties for CHMP requested inspections, refer to the Union procedure on the coordination of EU
        pharmacovigilance inspections.
      • Announcement communications could include, for example, the

        Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 4/16

        name of the inspector(s), MAH, the objectives and nature of the inspection (i.e.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 5/16

        ?

        Feedback from other competent authority functions, in particular pharmacovigilance assessors.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 6/16

        ?

        If teleconference(s) are planned during the inspection with experts, assessors, MAH personnel
        located off site etc.

      • ?

        Union procedure on the management of pharmacovigilance inspection findings which may impact
        the robustness of the benefit-risk profile of the concerned medicinal products.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 12/16

        Appendix 1 ?Pharmacovigilance inspection report
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 13/16

        Appendix 2- Inspection overview (IO)
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 14/16

        Appendix 3- Pharmacovigilance inspection outcome sharing
        Click here for the template.

      • Union procedure on the preparation, conduct and reporting of EU pharmacovigilance
        inspections
        EMA/INS/PhV/192230/2014

        Page 16/16

    Patient Safety Movement Foundation Outlines 2024 Action Plan for Creating a Safer Healthcare System

    Retrieved on: 
    Saturday, February 17, 2024
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    At the Patient Safety Movement Foundation’s annual Mid-Year Event on January 26, patient safety experts from around the world participated in the creation of an action plan to eliminate preventable patient and healthcare worker harm.

    Key Points: 
    • At the Patient Safety Movement Foundation’s annual Mid-Year Event on January 26, patient safety experts from around the world participated in the creation of an action plan to eliminate preventable patient and healthcare worker harm.
    • The Patient Safety Leadership Association was inaugurated by the Patient Safety Movement Foundation to respond to the need for a targeted forum for chief quality and patient safety officers and patient safety activists.
    • View the full release here: https://www.businesswire.com/news/home/20240217110649/en/
      Dr. Mike Ramsay, CEO of the Patient Safety Movement Foundation, addresses attendees at the 2024 Mid-Year Event about the urgent steps the healthcare system needs to take to protect patient safety.
    • More information about the Patient Safety Leadership Association is available on the Patient Safety Movement Foundation’s website at: https://psmf.org/patient-safety-leadership-association/ .

    A Practical Guide to Producing and Maintaining the Pharmacovigilance System Master File (PSMF) Training Course (ONLINE EVENT) - ResearchAndMarkets.com

    Retrieved on: 
    Thursday, February 8, 2024
    Health, Pharmaceutical, PSMF, Safety, Pharmacovigilance, Marketing, European, Medical device

    The "A Practical Guide to Producing and Maintaining the PSMF Training Course" conference has been added to ResearchAndMarkets.com's offering.

    Key Points: 
    • The "A Practical Guide to Producing and Maintaining the PSMF Training Course" conference has been added to ResearchAndMarkets.com's offering.
    • This course will be relevant for anyone working in pharmacovigilance who requires a comprehensive overview of the PSMF, including QPPVs and those responsible for safety assessments.
    • The pharmacovigilance system master file (PSMF) is a legal requirement for any medicinal product authorised in the European Union.
    • This course will provide a practical guide to planning, writing, maintaining and updating the PSMF to ensure compliance.

    Patient Safety Movement Foundation’s Mid-Year Meeting Charts Course for Global Patient Safety Initiatives in 2024

    Retrieved on: 
    Saturday, January 27, 2024
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    The Patient Safety Movement Foundation (PSMF) convened its annual Mid-Year Event to discuss safety challenges in the healthcare system that result in millions of preventable deaths around the world.

    Key Points: 
    • The Patient Safety Movement Foundation (PSMF) convened its annual Mid-Year Event to discuss safety challenges in the healthcare system that result in millions of preventable deaths around the world.
    • View the full release here: https://www.businesswire.com/news/home/20240126619652/en/
      Patient Safety Movement Foundation Founder Joe Kiani speaks about the road ahead in global efforts to eliminate preventable patient harm at the PSMF's annual Mid-Year Event.
    • In 2012, Joe Kiani founded the non-profit Patient Safety Movement Foundation (PSMF) to eliminate preventable medical errors in hospitals.
    • His team worked with patient safety experts from around the world to create Actionable Evidence-Based Practices (AEBP) that address the top challenges.

    A Practical Guide to Producing and Maintaining the PSMF Training Course: A Legal Requirement for Any Medicinal Product Authorised in the European Union - ResearchAndMarkets.com

    Retrieved on: 
    Friday, December 15, 2023
    Pharmaceutical, Legal, Professional Services, Health, Marketing, PSMF, Safety, Pharmacovigilance, Brexit

    The "A Practical Guide to Producing and Maintaining the PSMF Training Course" conference has been added to ResearchAndMarkets.com's offering.

    Key Points: 
    • The "A Practical Guide to Producing and Maintaining the PSMF Training Course" conference has been added to ResearchAndMarkets.com's offering.
    • This course will provide a practical guide to planning, writing, maintaining and updating the PSMF to ensure compliance.
    • The programme will cover the importance of the PSMF in regulatory inspections, including common PSMF inspection findings.
    • Gain an overview of the key issues in producing, maintaining and updating the PSMF

    PCAST Working Group, Co-Led by PSMF Founder Joe Kiani, Releases Report on Transforming Patient Safety

    Retrieved on: 
    Friday, September 8, 2023
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    Titled “A Transformational Effort on Patient Safety,” the report also outlines the many ways that “patient safety is an urgent national public health issue.” The distinguished PCAST Working Group on Patient Safety is co-led by the founder of the Patient Safety Movement Foundation , Joe Kiani , and Microsoft’s Chief Scientific Officer, Eric Horvitz.

    Key Points: 
    • Titled “A Transformational Effort on Patient Safety,” the report also outlines the many ways that “patient safety is an urgent national public health issue.” The distinguished PCAST Working Group on Patient Safety is co-led by the founder of the Patient Safety Movement Foundation , Joe Kiani , and Microsoft’s Chief Scientific Officer, Eric Horvitz.
    • I am optimistic that these recommendations will help fast-track solving this critical problem that destroys so many lives,” said Joe Kiani, co-leader of the PCAST Working Group on Patient Safety.
    • 1.A Appoint a Patient Safety Coordinator Reporting to the President on Efforts to Transform Patient Safety Among All Relevant Government Agencies.
    • Joe Kiani, who founded the Patient Safety Movement Foundation (PSMF) in 2012 and served for many years as its first chair, was appointed to PCAST in September 2021.

    The Patient Safety Movement Foundation Concludes Its 10th Annual World Patient Safety, Science & Technology Summit

    Retrieved on: 
    Saturday, June 3, 2023
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    President Bill Clinton, 42nd President of the United States, headlined day two of the 10th Annual World Patient Safety, Science & Technology Summit, presented by the Patient Safety Movement Foundation (PSMF).

    Key Points: 
    • President Bill Clinton, 42nd President of the United States, headlined day two of the 10th Annual World Patient Safety, Science & Technology Summit, presented by the Patient Safety Movement Foundation (PSMF).
    • View the full release here: https://www.businesswire.com/news/home/20230602005417/en/
      Joe Kiani, founder of the Patient Safety Movement Foundation, discusses efforts to improve patient safety worldwide with former President Bill Clinton at the 10th Annual World Patient Safety, Science & Technology Summit in Newport Beach, California.
    • His team worked with patient safety experts from around the world to create Actionable Evidence-Based Practices (AEBP) that address the top challenges.
    • The Foundation's annual World Patient Safety, Science & Technology Summit brings together all stakeholders, including patients, healthcare providers, medical technology companies, government employers, and private payers.

    10th Annual World Patient Safety, Science & Technology Summit Begins

    Retrieved on: 
    Friday, June 2, 2023
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    Day one of the 10th Annual World Patient Safety, Science & Technology Summit presented by the Patient Safety Movement Foundation (PSMF) saw global leaders across the world of patient safety call for an increased urgency in addressing the issue of preventable harm within healthcare.

    Key Points: 
    • Day one of the 10th Annual World Patient Safety, Science & Technology Summit presented by the Patient Safety Movement Foundation (PSMF) saw global leaders across the world of patient safety call for an increased urgency in addressing the issue of preventable harm within healthcare.
    • View the full release here: https://www.businesswire.com/news/home/20230601006140/en/
      Joe Kiani, founder of the Patient Safety Movement Foundation, speaks at the 10th Annual World Patient Safety, Science & Technology Summit in Newport Beach, California.
    • His team worked with patient safety experts from around the world to create Actionable Evidence-Based Practices (AEBP) that address the top challenges.
    • The Foundation's annual World Patient Safety, Science & Technology Summit brings together all stakeholders, including patients, healthcare providers, medical technology companies, government employers, and private payers.

    10th Annual World Patient Safety, Science & Technology Summit Is Sold Out!

    Retrieved on: 
    Saturday, May 27, 2023
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    Registration for the 10th Annual Patient Safety, Science & Technology Summit is now closed.

    Key Points: 
    • Registration for the 10th Annual Patient Safety, Science & Technology Summit is now closed.
    • View the full release here: https://www.businesswire.com/news/home/20230526005374/en/
      Annual World Patient Safety, Science & Technology Summit (Photo: Business Wire)
      “We are very encouraged at the response we received for our first in-person Summit since Covid-19,” said Dr. Michael Ramsay, CEO, Patient Safety Movement Foundation.
    • We will also hear directly from patients and families affected by preventable medical errors.”
      For more information about the 10th Annual World Patient Safety, Science & Technology Summit and future events, please visit https://psmf.org/events .
    • The Foundation's annual World Patient Safety, Science & Technology Summit brings together all stakeholders, including patients, healthcare providers, medical technology companies, government employers, and private payers.