Pharmacovigilance Course

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Description

Pre-Booking Coupon CODE  : PNFT50

Pharmacovigilance Mastery Program (45 Days Intensive)

🔹 Course Highlights

✨ 42 Hours On-Demand Video
📚 31 Articles + Books Included
📝 Quiz After Every Lecture
📱 Access on Mobile & Laptop
🏆 Industry-Recognized Certification
💼 Interview Question Bank
📄 Resume Samples Included
🛠️ Dedicated Technical Support


📘 MODULE STRUCTURE

🟢 Module 1: Foundation of Pharmacovigilance

  • Introduction & Evolution of Pharmacovigilance
  • Basic Terminologies in PV
  • Global Importance of Drug Safety

🔵 Module 2: Adverse Drug Reactions (ADR)

  • Types & Classification of ADR
  • Mechanisms of ADR
  • Real Clinical Case Studies

🟣 Module 3: Global PV Regulations & Systems

  • WHO Drug Monitoring Programme
  • ATC Classification System
  • International Regulatory Frameworks

🟡 Module 4: Signal Detection & Drug Safety

  • Signal Detection Methods
  • Risk Identification Techniques
  • Data Interpretation in PV

🔴 Module 5: Drug Safety Monitoring

  • Post-Marketing Surveillance
  • Safety Monitoring Strategies
  • Case Processing Workflow

🟠 Module 6: Pharmacovigilance Data Management

  • Data Collection & Validation
  • ICSR Processing
  • Database Handling & Reporting

🟤 Module 7: Risk Management in PV

  • Risk Management Plans (RMP)
  • Benefit-Risk Assessment
  • Minimization Strategies

Module 8: PV Audit & Inspection

  • Audit Procedures
  • Regulatory Inspections
  • Compliance Requirements

Module 9: Good Pharmacovigilance Practices (GVP)

  • GVP Guidelines
  • Quality Systems in PV
  • Documentation Standards

🟢 Module 10: MedDRA & Pharmacoepidemiology

  • MedDRA Coding System
  • Drug Utilization Studies
  • Epidemiological Concepts

🔵 Module 11: Drug Safety Communication

  • Safety Reports & Alerts
  • Communication Strategies
  • Regulatory Submissions

🟣 Module 12: Special Pharmacovigilance Areas

  • Herbal Medicines PV
  • Medical Devices & Vaccines
  • Pregnancy & Lactation Safety
  • Paediatrics & Geriatrics

🟡 Module 13: CIOMS & Safety Reporting

  • CIOMS Guidelines
  • PSUR (Periodic Safety Update Reports)
  • ICSR Documentation

🔴 Module 14: Future of Pharmacovigilance

  • AI in Pharmacovigilance
  • Automation & Digital PV
  • Industry Trends & Career Scope

🟠 Module 15: Clinical Pharmacology Integration

  • Anti-Hypertensive Drugs
  • Anti-Diabetic Drug Classification
  • Anti-Neoplastic Drugs
  • NSAIDs & Blood Disorders

🟤 Module 16: Immunology & Hematology Basics

  • WBC & RBC Functions
  • Antigen & Antibody Concepts
  • Clinical Relevance in Drug Safety

🚀 Bonus Section (Career Boosters)

  • 💼 Interview Preparation Bank
  • 📄 Ready-to-Use Resume Templates
  • 🎯 Industry-Oriented Case Studies
  • 🧠 Quiz-Based Learning After Each Module

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