Course Duration: 45 Hours
This paper will provide an opportunity for the student to learn about development of pharmacovigilance as a science, basic terminologies used in pharmacovigilance, global scenario of Pharmacovigilance, train students on establishing pharmacovigilance programme in an organization, various methods that can be used to generate safety data and signal detection. This paper also develops the skills of classifying drugs, diseases and adverse drug reactions.
At completion of this paper it is expected that students will be able to (know, do, and appreciate):
- Why drug safety monitoring is important?
- History and development of pharmacovigilance
- National and international scenario of pharmacovigilance
- Dictionaries, coding and terminologies used in pharmacovigilance
- Detection of new adverse drug reactions and their assessment
- International standards for classification of diseases and drugs
- Adverse drug reaction reporting systems and communication in pharmacovigilance
- Methods to generate safety data during pre clinical, clinical and post approval phases of drugs’ life cycle
- Drug safety evaluation in paediatrics, geriatrics, pregnancy and lactation
- Pharmacovigilance Program of India (PvPI) requirement for ADR reporting in India
- ICH guidelines for ICSR, PSUR, expedited reporting, pharmacovigilance planning
- CIOMS requirements for ADR reporting
- Writing case narratives of adverse events and their quality.