ADVANCED DIPLOMA IN PHARMACOVIGILANCE

Duration   3 Months
Fees   35 Thousand

Eligibility

Medical - MBBS, BDS, Post Graduate in Medicine & other specialists
Pharmacy - B Pharm, D Pharm, M. Pharm,
Classes   2 days per week
Faculty   Industry Professionals & Experts
Job Opportunities   Drug Safety Scientist / Medical Reviewer / Quality Analyst in pharmacovigilance / Safety Reviewer
Job Openings   TCS, Accenture,Cognizant,Quintiles,Lambda

PHARMACOVIGILANCE COURSE MODULES

1. Pharmacovigilance
  • Introductions to CR /PV Course Objectives
  • Basics of Clinical Research
  • Historical Perspectives
  • ADR Definition; Classification; Identification
  • ADR Assessment & Reporting
  • Causality Assessment of Suspected Adverse Drugs Reactions
  • Management of Pharmacovigilance Data
  • Risk Management in Pharmacovigilane
  • Importance of PV National & International Scenario
  • Regulatory Aspect of PV
  • Establishment of PV Program
  • Drug Dictionary + Coding in PV
  • Drug Safety Evaluation in Special Population
  • Communication in PV
  • ICH and PV
  • Risk Management Plan
  • PV Compliance and Inspection
  • Practical MEDRA and Other Dictionary
  • Practical Case Processing
  • Practical Narrative Writing
  • Pharmacovigilance Software
  • Aggregate reporting & PSUR



2. Mock Interview
  • Inter Personal Skills
  • Group Discussions
  • Soft Skills
  • Personality Development
3. Seminar & Final Examination
COURSE MODULES
ADVANCED DIPLOMA


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