Define Pharmacovigilance. Discuss scope and purpose of Pharmacovigilance.
[6 marks]Write a note on ADR in public health.
[5 marks]Explain role of ICSRs in pharmacovigilance.
[5 marks]Write a note on validity and assessment of ICSRs reports.
[6 marks]Define medication error. Discuss types of medication errors.
[5 marks]Write about sources and scope of signal detection.
[5 marks]Write down characterization of pharmacovigilance in clinical trials.
[6 marks]Define SRS. Write down limitations of SRS.
[5 marks]Explain pattern and scale of counterfeiting.
[5 marks]Define ADR. Discuss various types of ADR.
[6 marks]Explain methods of pharmacovigilance.
[5 marks]Write about pharmacovigilance regulation in INDIA.
[5 marks]Explain about WHO and medDRA in briefs.
[6 marks]Write a note on SSFFC medicines.
[5 marks]Discuss the role of pharmacist to prevent medication errors. Q. 6 (a) What is ICSRs? Write about types of ICSRs.
[6 marks]Write a note on adverse hepatic reactions.
[5 marks]Explain pharmacovigilance regulation in USA.
[5 marks]Discuss factors and mechanisms of ADRs.
[6 marks]Write about access and confidentiality Spontaneous ICSR Reporting Systems.
[5 marks]Write down contents and structure of ICSRs.
[5 marks]