1. To provide an opportunity
for the students to learn about development of Pharmacovigilance as a science,
basic terminologies used in Pharmacovigilance, global scenario of
Pharmacovigilance.
2. To train students on
establishing Pharmacovigilance programs in an organization, various methods
that can be used to generate safety data and signal detection.
SYLLABUS
1. Introduction to clinical
research and Pharmacovigilance and their importance
• Clinical
trial history and stages
• History
and development of Pharmacovigilance
2. Definitions and Basic
terminologies used in Pharmacovigilance
3. ICH-GCP Guidelines and
Guidelines on Good Pharmacovigilance Practices (GVP)
4. SAE Reporting Amendments to
DCGI in India
5. Seriousness and Causality
assessment
6. Dechallenge and Rechallenge
7. Drug dictionaries and coding
in Pharmacovigilance
• MedDRA
and Standardized MedDRA queries
• WHO
drug dictionary
8. Signal detection, Risk
assessment and management
• Identification
of new adverse drug reactions
• Signal
detection in pre and post marketing period
• Prioritization
and risk assessment
• Risk
management
9. Argus Safety Databse
10. Case Narratives
• Regulatory
perspectives of narrative writing
• Case
narratives from clinical trial data
• Case narratives from post marketing
reporting
• Quality assessment of case narratives
• Spontaneous Case reporting
• Literature Case reporting
11.
Information resources in Pharmacovigilance
• Basic drug information resources
• Specialized resources for ADRs
• Critical evaluation of medication
safety literature
• CIOMS
12.
Communication in Pharmacovigilance
• Effective communication in
Pharmacovigilance
• Communication in Drug Safety Crisis
management
• Communicating with Regulatory
Agencies, Business Partners, Healthcare facilities & Media
• Dear Doctor Letters to Healthcare
Professionals and e-mail etiquettes
• E-mail etiquettes
13. On Job
Responsibilities
14. Resume
Preparation
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