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.

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Setting up of new pharmacovigilance centres

  1. 1. Pharmacovigilance Centre<br />Proposal By<br />Cure & Care Pharma<br />Abu building,<br />New Delhi<br />1<br />Cure & Care Pharma Confidential Report<br />
  2. 2. Cure & Care Pharma<br />Leading & fast growing pharmaceutical company involved in manufacturing & marketing of ethical pharmaceutical formulations, neutraceuticals and veterinary products<br />Founded in 1984<br />Penetrated various therapeutic areas like Pain Management, Diabetes, Orthopaedics, Cardiovascular, Erectile dysfunction, nutrients<br />Equipped with modern facilities, it implemented Information technology & Telecommunication<br />Certification by World Health Organisation authority (WHO-GMP)<br />2<br />Cure & Care Pharma Confidential Report<br />
  3. 3. Pharmacovigilance Centre<br /> Is a centre of expertise for the art and science of monitoring and analysis of drug.<br /> Should be set up with the approval of the authority responsible for the regulation of medicines (“regulatory authority”). <br /> Functions within the regulatory authority, a hospital, an academic institution or as an independent facility such as a trust or foundation.<br />3<br />Cure & Care Pharma Confidential Report<br />
  4. 4. Pharmacovigilance Framework<br />4<br />Cure & Care Pharma Confidential Report<br />
  5. 5. Need of Pharmacovigilance<br />Cure & Care Pharma Confidential Report<br />5<br />Increasing availability of drugs<br />Too many drugs and irrational combination<br />Aggressive marketing<br />Irrational Practice<br />Treatment without provisional diagnose<br />Wrong choice and incorrect dose of drug<br />Lack of documentation<br />Resultant medical errors lead to ADEs and not ADRs<br />Lack of culture of rational practice and following protocols<br />
  6. 6. Why the need for pharmacovigilance<br />6<br />Cure & Care Pharma Confidential Report<br />
  7. 7. Scope<br />To communicate about the risks and benefits to patients, prescriber and public<br />To undertake active surveillance depending upon the availability of support system<br />To provide training to healthcare provider about the ADR reporting procedures<br />To communicate drug related information to national regulatory authorities which in turn communicate with other national regulatory authorities to discuss the safety data<br />To raise the public awareness of the drug safety and contribute to development of public health policy<br />7<br />Cure & Care Pharma Confidential Report<br />
  8. 8. Who can report<br />Any health care professional (doctor including dentist, nurses, pharmacist) <br />Consumer<br />Patient<br />Marketing authorization holder<br />8<br />Cure & Care Pharma Confidential Report<br />
  9. 9. Way to report<br />Manual submission of form<br />CDSCO Reporting Form<br />SAEForm_General.doc<br />Online submission to<br /><br />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<br />9<br />Cure & Care Pharma Confidential Report<br />
  10. 10. What happened to submitted information<br />10<br />Cure & Care Pharma Confidential Report<br />
  11. 11. need to provide such emerging centres with some information:<br />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.<br />11<br />Cure & Care Pharma Confidential Report<br />
  12. 12. Financial Requirements<br />Infrastructure<br />Human Resource<br />Communication<br />Operation Expenses<br />12<br />Cure & Care Pharma Confidential Report<br />
  13. 13. Capacity Building Model<br />13<br />Cure & Care Pharma Confidential Report<br />
  14. 14. Infrastructure<br />Location<br />Equipments<br />Database<br />14<br />Cure & Care Pharma Confidential Report<br />
  15. 15. Communication<br />Multiline Telephone<br />Internet<br />FAX<br />15<br />Cure & Care Pharma Confidential Report<br />
  16. 16. Operation Expenses<br />Electricity<br />Maintenance<br />Miscellaneous Day To Day<br />16<br />Cure & Care Pharma Confidential Report<br />
  17. 17. Human Resource<br />17<br />Cure & Care Pharma Confidential Report<br />
  18. 18. Budget<br />18<br />Cure & Care Pharma Confidential Report<br />
  19. 19. Budget Analysis<br />19<br />Cure & Care Pharma Confidential Report<br />
  20. 20. Reporting Database<br />Vigibase Online<br />It is web-based reporting software solution for pharmacovigilance centre. This software allows seamless electronic transmission of reports within a country <br />This web makes possible improved communication between prescriber and pharmacovigilance centres.<br />20<br />Cure & Care Pharma Confidential Report<br />
  21. 21. Why vigibase<br />The main features of vigibase online is:<br />It is an advanced security system that makes it available only for authorized personnel to avoid illicit access to data.<br />The system can set up online ADR reporting by prescriber <br />The report is made available to the first level of assessment either a regional or national centre.<br />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.<br />21<br />Cure & Care Pharma Confidential Report<br />
  22. 22. Hurdle in planning the PVG center<br />Cure & Care Pharma Confidential Report<br />22<br />Lack of spontaneous reporting.<br />Lack of Awareness.<br />Time Consuming and Tedious<br />Scientific support, academic resources and training to the people involved <br />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<br />Additional infrastructure (personnel, a dedicated telephone line and internet connection) can also improve the scope and functioning of the center<br />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.<br />
  23. 23. Annexure<br />Cure & Care Pharma Confidential Report<br />23<br />Annexure I SAE Form General<br />Annexure II CDSCO AE Reporting Form<br />Annexure III User Manual <br />
  24. 24. 24<br />Thank You<br />Presented by <br />Tina<br />Naveen<br />Priti<br />Cure & Care Pharma Confidential Report<br />