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Setting up of new pharmacovigilance centres

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this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.

this is just an overview of the setting up of pharamcovigilance with fake name of company and product. budget is also an imagination. there is not exact representation of the actual situation.

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  • 1. Pharmacovigilance Centre
    Proposal By
    Cure & Care Pharma
    Abu building,
    New Delhi
    1
    Cure & Care Pharma Confidential Report
  • 2. Cure & Care Pharma
    Leading & fast growing pharmaceutical company involved in manufacturing & marketing of ethical pharmaceutical formulations, neutraceuticals and veterinary products
    Founded in 1984
    Penetrated various therapeutic areas like Pain Management, Diabetes, Orthopaedics, Cardiovascular, Erectile dysfunction, nutrients
    Equipped with modern facilities, it implemented Information technology & Telecommunication
    Certification by World Health Organisation authority (WHO-GMP)
    2
    Cure & Care Pharma Confidential Report
  • 3. Pharmacovigilance Centre
    Is a centre of expertise for the art and science of monitoring and analysis of drug.
    Should be set up with the approval of the authority responsible for the regulation of medicines (“regulatory authority”).
    Functions within the regulatory authority, a hospital, an academic institution or as an independent facility such as a trust or foundation.
    3
    Cure & Care Pharma Confidential Report
  • 4. Pharmacovigilance Framework
    4
    Cure & Care Pharma Confidential Report
  • 5. Need of Pharmacovigilance
    Cure & Care Pharma Confidential Report
    5
    Increasing availability of drugs
    Too many drugs and irrational combination
    Aggressive marketing
    Irrational Practice
    Treatment without provisional diagnose
    Wrong choice and incorrect dose of drug
    Lack of documentation
    Resultant medical errors lead to ADEs and not ADRs
    Lack of culture of rational practice and following protocols
  • 6. Why the need for pharmacovigilance
    6
    Cure & Care Pharma Confidential Report
  • 7. Scope
    To communicate about the risks and benefits to patients, prescriber and public
    To undertake active surveillance depending upon the availability of support system
    To provide training to healthcare provider about the ADR reporting procedures
    To communicate drug related information to national regulatory authorities which in turn communicate with other national regulatory authorities to discuss the safety data
    To raise the public awareness of the drug safety and contribute to development of public health policy
    7
    Cure & Care Pharma Confidential Report
  • 8. Who can report
    Any health care professional (doctor including dentist, nurses, pharmacist)
    Consumer
    Patient
    Marketing authorization holder
    8
    Cure & Care Pharma Confidential Report
  • 9. Way to report
    Manual submission of form
    CDSCO Reporting Form
    SAEForm_General.doc
    Online submission to www.cdsco.nic.in
    www.candc.com/aereporting
    In case of any doubt you may send this form to the national pharmacovigilance center at CDSCO, Directorate General Of Health Services, Ministry Of Health And Family Welfare, NirmanBhawan, New Delhi
    9
    Cure & Care Pharma Confidential Report
  • 10. What happened to submitted information
    10
    Cure & Care Pharma Confidential Report
  • 11. need to provide such emerging centres with some information:
    the materials and resources required• how to operate• what kind of support is needed• where to find adequate literature sources• what kind of assistance can be expected• what is the relationship to be sought with drug information centres and poison information systems, and so on.
    11
    Cure & Care Pharma Confidential Report
  • 12. Financial Requirements
    Infrastructure
    Human Resource
    Communication
    Operation Expenses
    12
    Cure & Care Pharma Confidential Report
  • 13. Capacity Building Model
    13
    Cure & Care Pharma Confidential Report
  • 14. Infrastructure
    Location
    Equipments
    Database
    14
    Cure & Care Pharma Confidential Report
  • 15. Communication
    Multiline Telephone
    Internet
    FAX
    15
    Cure & Care Pharma Confidential Report
  • 16. Operation Expenses
    Electricity
    Maintenance
    Miscellaneous Day To Day
    16
    Cure & Care Pharma Confidential Report
  • 17. Human Resource
    17
    Cure & Care Pharma Confidential Report
  • 18. Budget
    18
    Cure & Care Pharma Confidential Report
  • 19. Budget Analysis
    19
    Cure & Care Pharma Confidential Report
  • 20. Reporting Database
    Vigibase Online
    It is web-based reporting software solution for pharmacovigilance centre. This software allows seamless electronic transmission of reports within a country
    This web makes possible improved communication between prescriber and pharmacovigilance centres.
    20
    Cure & Care Pharma Confidential Report
  • 21. Why vigibase
    The main features of vigibase online is:
    It is an advanced security system that makes it available only for authorized personnel to avoid illicit access to data.
    The system can set up online ADR reporting by prescriber
    The report is made available to the first level of assessment either a regional or national centre.
    When the report is completed, it is updated for searching by the reporting centre and all other national centres. It will then be available for statistical analysis of any type ADR of reported by national centres.
    21
    Cure & Care Pharma Confidential Report
  • 22. Hurdle in planning the PVG center
    Cure & Care Pharma Confidential Report
    22
    Lack of spontaneous reporting.
    Lack of Awareness.
    Time Consuming and Tedious
    Scientific support, academic resources and training to the people involved
    A feedback provided about the status of reports submitted, deficiencies if any and results of casualty assessment provide us an insight about quality of work and reports
    Additional infrastructure (personnel, a dedicated telephone line and internet connection) can also improve the scope and functioning of the center
    Knowing the status of our reports vis-a-vis the global database would be an added feedback that will not only help us introspect and improve, but also provide us a valid authenticated document that could convince the skeptics among the clinicians about the value of their spontaneous reports.
  • 23. Annexure
    Cure & Care Pharma Confidential Report
    23
    Annexure I SAE Form General
    Annexure II CDSCO AE Reporting Form
    Annexure III User Manual
  • 24. 24
    Thank You
    Presented by
    Tina
    Naveen
    Priti
    Cure & Care Pharma Confidential Report