PSMF

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Retrieved on: 
Dienstag, Mai 28, 2024
Transfer, Steps, Scroll, SPC, Q&A, Google Chrome, European Medicines Agency, VET, Lead, Product lifecycle, Medical device, EMA, GVP, Canonical form, Common, NOT, Companion, PO, Chikungunya, Nature, Location, Button, Sponsor, Task force, PV, Web browser, Public, Workflow, Iris, Outcome, Purchase order, Partex Group, Prevalence, Update, Person, Medicine, Committee, Record, Approximation error, Protocol, Risk, Availability, EEA, Bulk, CVMP, Figure, Signal, PHE, Language, Zika virus, ECTD, Letter, SharePoint, Authorization, Name, Communication, Inspectorate, MIA, PRIME, MAA, Reproduction, European, Glass, Chromium, Section, Marketing, PIP, EAF, Organization, Safety, PLM, Mode, SAS, Treatment, ETF, Sunset, MAH, Standard, MSD, Directive 2001/83/EC, GMP, Public health, Self-management, Union, MSO, Report, Microsoft Excel, Browser, GCP, Civil service commission, N.B, Common Technical Document, VSI, Section 8, Qualification, Withdrawal, Date, Draft, SME, Abbreviation, Access management, Headquarters, PDF, Diagnosis, Section 4, HR, State, History, NEXT, PASS, PSMF, RPI, Save, MB, Inspection, SAP, COVID, Process, Research, Validation, VS, SAWP, Art, European Commission, Translation, Literature, PD, Public Security Section 9, Clinical trial, PRI, Brief, Submission, Annual report, ITF, KOM, Substance, Marketing authorisation, Parallel, Documentation, Contact lens, Human, CHMP, Risk management

IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants

Key Points: 

    Understanding Pharmacovigilance Regulations in APAC Training Course (ONLINE EVENT) - ResearchAndMarkets.com

    Retrieved on: 
    Mittwoch, Mai 15, 2024
    Health, Pharmaceutical, RMP, PSMF, GVP, Pharmacovigilance, Safety

    The "Understanding Pharmacovigilance Regulations in APAC Training Course" conference has been added to ResearchAndMarkets.com's offering.

    Key Points: 
    • The "Understanding Pharmacovigilance Regulations in APAC Training Course" conference has been added to ResearchAndMarkets.com's offering.
    • This two-day pharmacovigilance webinar has been designed to provide a comprehensive guide to compliance in this geographic region.
    • It will provide an ideal opportunity to keep up-to-date with the latest Good Pharmacovigilance Practices (GVP) and post market PV operations in China, and post-market pharmacovigilance regulations in Singapore, Malaysia, the Philippines, and Australia.
    • Gain key takeaways to better understand the new GVP regulations and pharmacovigilance compliance in these countries.

    EudraVigilance registration manual

    Retrieved on: 
    Mittwoch, April 3, 2024
    Scroll, University, Data analysis, Patient, Account, Organization, MAH, Medicine, Manual, MFL, IAM, VAT, Finalize (optical discs), QAT, Competence, Documentation, Letter, Privacy, HQ2, ServiceNow, Environment, Trust (social science), RP, Table, Record, MPR, European Medicines Agency, Restricted area, Yahoo!, Identity management, Change request, Access, Qualified person (European Union), HQ, MMD, Home, Hospital, Research, Service, Network affiliate, Comment, Access management, OMS, Send, MSSO, ISO, Commercial, European, NCA, NCS, Managed services, Next, Document, EMA, PSMF, Language, MedDRA, AMP, Database, ICSR, Figure, EudraGMP, Dictionary, AMPS, Reproduction, Quality assurance, Identity, Virtual, Q2, SME, Change, Importance, Management, Security, Name, Location, Sponsor, Completeness, ID, 24 Hours, User, Vaccine
    Key Points: 

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

      Retrieved on: 
      Mittwoch, April 3, 2024
      Community, Reproduction, Appendix, European Medicines Agency, Patient, Parliament, MAH, Council, Member state, European, NCA, GxP, Legislation, Communication, Comment, Classification, Partnership, Risk, Committee, PSMF, Safety, Calendar, CHMP, State, Documentation, Public, Directive 2001/83/EC, IWG, GVP, Commission, CAPA, Guideline, IO, Computer, PRAC, European Parliament, Registry, Record, Peer review, Language, Collection, Inspection

      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: 
      Samstag, Februar 17, 2024
      Philanthropy, Health, Hospitals, Practice Management, Foundation, General Health, PSMF, Hospital, Algorithm, Workplace, Multimedia, Intelligence, Culture, ZERO, Cause of action, Approximation error, Competition, Open data, Safety, Patient safety, Patient, Knowledge, Movement, Face, Pharmaceutical industry

      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: 
      Donnerstag, Februar 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: 
      Samstag, Januar 27, 2024
      Nursing, Public Policy, Government, Health, Healthcare Reform, Hospitals, Health Insurance, General Health, Momentum, Patient safety, World Health Organization, Patient, Hospital, Cause of action, Open data, Evidence-based medicine, Multimedia, ApiJect Systems, Summit, Competition, University, Algorithm, Johns Hopkins, PCAST, PSMF, Safety, Public health, ZERO, Approximation error

      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: 
      Freitag, Dezember 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: 
      Freitag, September 8, 2023
      Technology, General Health, Public Policy, Government, Foundation, Philanthropy, Hospitals, Science, Cardiology, Diabetes, Health, Health Technology, Public Safety, Research, White House, Federal Government, Software, Advocacy Group Opinion, Artificial Intelligence, Approximation error, Harness, Private sector, Society, Use, Harm, Safety, Health equity, Social, Patient, Information, PSMF, Address, Organization, Patient safety, National Priority, LHC Accelerator Research Program, Develop, Culture, National Patient Safety Foundation, Death, Pharmaceutical industry, Nursing, Medical device, Person, PCAST

      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: 
      Samstag, Juni 3, 2023
      Other Policy Issues, Practice Management, Medical Supplies, Technology, General Health, Telemedicine, Virtual Medicine, Public Policy, Government, Other Health, Surgery, Pharmaceutical, Healthcare Reform, Infectious Diseases, Health Technology, Hospitals, Other Technology, Philanthropy, Biotechnology, Health, Foundation, President Clinton, Approximation error, Optimism, Meet the Future, Science & Technology Summit 2010, University, Centers for Medicare & Medicaid Services, Hospital, Multimedia, ZERO, PSMF, Competition, Medicare, Death, Patient, Patient safety, Algorithm, Open data, United Kingdom, Knowledge, Francisco Valero-Cuevas, Philips, Cause of action, Summit, World Health Organization, World Patient Safety Day, Pharmaceutical industry, Nursing, Satellite navigation device, Science, Health care, Ethics

      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.