ESTABLISHMENT OF PHARMACOVIGILANCE (Clinical Research & Pharmacovigilance).pptx

The contents in these slides include Establishment of PV centres in hospital& Industry, National programmes related to PV, and Roles & responsibilities in PV.

1. ESTABLISHMENT OF PHARMACOVIGILANCE Presented by: Simrose Fateema Roll no. 51 M. Pharm 1 st year 2 nd semester Subject Incharge : Dr. Dureshahwar Mam (PEER Assisted Learning) 1 MAULANA AZAD EDUCATIONAL TRUST'S    Y . B. CHAVAN COLLEGE OF PHARMACY, AURANGABAD  

2. CONTENT Establishment of PV centres in hospital, Industry. National programmes related to PV. Roles and responsibilities in PV 2

3. Establishment of PV in hospitals Basic requirement Data acquisition b. Dissemination Establishment Internal education Database design Promotion Networking Manpower and machinery Funding 3

4. Case Report form: Report of suspected ADRs are taken in CRF with following information. Patient ADE monitoring Suspected medicines Risk factor 4

5. Constitution and functioning Funds and government supports, manpower such as pharmacologist, toxicologist and computers, internet help in development of PV centres. PV centres provide free CRF to health care worker then they fill the CRF. DATA collection, classification and storage. Then DATA mining analysis, hypothesis and signal. Signal generated relevant, if yes Dissemination information education communication. 5

6. Role of PV in Hospitals DATA Processing Medicine regulation Information service Prevention of ADRs Hypothesizing 6

7. Establishment of PV in Industry Improves patient care and safety in relation to use of medicine. Protect patient from unrecognized drug hazards Carried out clinical trials before launching drug in market to ensure its safety and effectiveness. Calculate benefits to risk ratio. 7

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9. PV Programme in India Initiated by CDSCO and coordinated by AIIMS NEW Delhi Then in 2011 it was shifted to National Coordinating Centre (NCC) and Indian Pharmacopeia Commission, Gaziabad. 9

10. Mission: To provide benefits of medicine outweighs the risk Safeguard the health of the Indian population. Objectives: To monitor ADRs in populations. To create awareness among medical professionals about ADRs reporting. Generate evidence based recommendations on the safety of medicines. 10

11. Goals: To developed PV system in India. To encourage medical professionals in reporting of ADRs. Collection of CRF. To expand PV centres in all hospitals. To make ADR reporting mandatory To developed electronic reporting system. 11

12. Working Pattern of PV in India Health profession filled ADRs forms NCC check the completeness of the data Enter DATA in Vigiflow NCC analyzed and CDSCO for regulatory intervention. WHO Uppsala Centre, Sweden 12

13. National C oordinating Centre Preparation of SOP, guidance documents and training manual Cross check completeness. Reporting CDSCO headquarters. Conduct training workshop. CDSCO Take regulatory decision and action on the basis of recommendations of NCC. Collaboration with WHO Uppsala Monitoring Centre. Provide financial support to run PVPI . 13

14. 14 Role and responsibilities of PV Investigator Sponsor Monitor Study coordinator Contract research organization [ Role and responsibilities of the above mention personals in PV is similar to Clinical trial.]

15. THANK YOU ! 15