Discuss forms and formats of SRS.
[6 marks]Define Signal. Discuss sources and scope of signal detection.
[5 marks]Discuss potential and limitation of SRS.
[5 marks]Define : substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medicines,
[6 marks]Explain Pattern and scale of counterfeiting,
[5 marks]Write methods of detection of medication errors.
[5 marks]Explain current methods of Pharmacovigilance.
[6 marks]Write a note on Pharmacovigilance in clinical trial
[5 marks]Write a note on Pharmacovigilance regulation in india.
[5 marks]Write role of ICSRs in pharmacovigilance
[6 marks]Write a note on observational studies
[5 marks]Describe structure, validity and assessment of ICSRs in Pharmacovigilance
[5 marks]Define ADRs. Explain the types of ADRs with suitable examples.
[6 marks]Write role of pharmacist in the management of adverse drug reactions.
[5 marks]Differentiate between Adverse drug reaction and Adverse event. Q. 6 (a) What are merits and demerits of spontaneous reporting?
[6 marks]Write a note on adverse drug reactions of Liver
[5 marks]Write a note on Dermatological ADRs.
[5 marks]Write a note on naranjo’s causality assessment scale.
[6 marks]Explain spontaneous reporting of adverse drug reactions with suitable examples.
[5 marks]Write mechanism of ADRs with examples.
[5 marks]