P.G Diploma in Pharmacovigilance

Pharmacovigilance (PV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.[1] Generally speaking, pharmacovigilance is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:
identifying new information about hazards associated with medicines
preventing harm to patients.

Pharmacovigilance is particularly concerned with adverse drug reactions, or ADRs, which are officially described as: "A response to a drug which is noxious and unintended, and which occurs at doses normally used… for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function.

Pharmacovigilance is gaining importance for doctors and scientists as the number of stories in the mass media of drug recalls increases.[citation needed]

Because clinical trials involve several thousand patients at most; less common side effects and ADRs are often unknown at the time a drug enters the market. Even very severe ADRs, such as liver damage, are often undetected because study populations are small. Postmarketing pharmacovigilance uses tools such as data mining and investigation of case reports to identify the relationships between drugs and ADRs.

1. Principles  History and concepts of  Pharmacovigilance
2. Introduction to Pharmacovigilance and Pharmacoepidemiology
3. Functionalities of the Adverse Event Systems (AERS, VAERS and MAUDE)
4. Drug dictionary including Coding in MedDRA , WHO DD
5. Literature sources for ADR information
6. Sample reporting forms and practical experiences on recording
7. Global Pharmacovigilance and Safety Standards
8. The WHO and safety reporting
9. Adverse Drug Events
10. Medical Aspects of Adverse Drug Reactions from Various System Organ Class (SOCs)
11. Pharmacovigilance Reporting Systems and Tools for management of reports
12. Safety Reports
13. CIOMS function and ICH guidelines
14. Good Pharmacovigilance Practice
15. Pharmacovigilance regulations and guidelines
16. Regulations and guidelines of EU (EMEA), FDA, TGA and Japanese regulations
17. In depth understanding of Indian Regulations with specific inputs on Schedule Y
18. Individual case safety  and periodic safety  reports
19. Pre-marketing methodologies in Pharmacovigilance and clinical trials safety – need including EU Clinical Trials directive
20. Post marketing methodologies in Pharmacovigilance and post marketing drug safety
21. Difference in clinical and post marketing safety
22. Causality assessment – principles and case studies
23. Management of Drug Safety Data
24. Differing regulations concerning safety data collection requirements
25. Safety databases used in different parts of the world
26. Signal Detection
27. FDA and EU perspectives
28. Communicating with Regulatory Agencies, Business Partners, Healthcare Professionals & the Media
29. Pharmacovigilance Compliance and Inspections
30. Scope of Pharmacovigilance inspection and conduct of inspection
31. Internal audit of pharmacovigilance activities of a company
32. Pharmacovigilance inspection reports

 

 

Applicants for the Pharmacovigilance  Training Program are recommended to have one of the following:
Bachelor's, Masters, or a Ph.D. in a Science or Allied Health Field; OR Healthcare Professional  Medical Technologist, B.sc, M.sc life sciences.Pharmacy, Biotech, Computer.