The document discusses the challenges of pharmacovigilance. It outlines that pharmacovigilance aims to detect, assess, understand and prevent adverse drug reactions. However, there are challenges in detecting ADRs given limitations of preclinical data and changing drug use. Additional challenges include assessing ADRs, obtaining timely reporting from drug sponsors, and standardizing processes across organizations. The document calls for more education of healthcare professionals and patients about drug safety reporting to address gaps in pharmacovigilance.

1. The Challenges of Pharmacovigilance Presented by:- Dr. ROCHAK SONI ICRI (DELHI).

3. WHO definition of Pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem Dr.ROCHAK SONI

6. Detection of ADRs :- The education of doctors, pharmacists, industry and patients about drug safety and the importance of ADR reporting can certainly be listed among the greatest challenges. Dr.ROCHAK SONI

8. Drug Authority Dr.ROCHAK SONI Experience report Drug experience report Drug Information Drug Information Patient Health professional Drug info/ADR reporting Centre

9. Managing a signal A first signal Increasing information and knowledge Public Information 1 Public Information 2 Media coverage Also negative response SCARE Dr.ROCHAK SONI

11. Assessment of Problems in withdrawal & regulation Dr.ROCHAK SONI

15. Other Challenges of pharmacovigilience Dr.ROCHAK SONI

19. Challenges of pharmacovigilence in india Dr.ROCHAK SONI

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24. It is said that pharmacovigilance is not easy and its errors and problems tend to be repeated .[ 1 ] True, we have seen that before. We have had our share of errors and problems. We should now hope that the new programme will have a smooth sailing. It will help us improve the patient safety significantly . Dr.ROCHAK SONI

26. Managing a signal: the future Increasing information and knowledge also negative response Public Information 1 Public Information 2 Media coverage Pre-marketing risk management What do HPs and patients think and want A first signal Dr.ROCHAK SONI

30. Questions? Dr.ROCHAK SONI

31. Dr.ROCHAK SONI