Comprehensive Pharmacovigilance Training Course Overview

Module 1: Introduction to Pharmacovigilance

  • Definition and scope of pharmacovigilance
  • History and evolution of pharmacovigilance
  • Importance of pharmacovigilance in healthcare
  • Role of regulatory bodies (FDA, EMA, ICH, WHO, etc.)
  • Key terms in pharmacovigilance (e.g., Adverse Drug Reactions, Risk Management)

Module 2: Adverse Drug Reactions (ADRs)

  • Types of adverse drug reactions (Type A, Type B, Type C, etc.)
  • Classification of ADRs (e.g., dose-dependent, dose-independent)
  • Mechanisms of ADRs
  • Identification and reporting of ADRs
  • Factors influencing ADR occurrence (age, comorbidities, genetics, etc.)

Module 3: Pharmacovigilance Regulations and Guidelines

  • International regulations and guidelines (e.g., ICH E2E, ICH E2E Pharmacovigilance, ICH E2E Post-Marketing Surveillance)
  • Role of the International Conference on Harmonisation (ICH)
  • WHO Program for International Drug Monitoring
  • FDA and EMA guidelines
  • Indian Pharmacovigilance guidelines

Module 4: Pharmacovigilance Processes

  • Signal detection in pharmacovigilance
  • Data collection and reporting of adverse events (Spontaneous Reporting System)
  • Case processing (Data entry, assessment, and evaluation of ADRs)
  • MedDRA coding (Medical Dictionary for Regulatory Activities)
  • Signal analysis and risk management
  • Risk minimization strategies

Module 5: Drug Safety and Risk Management

  • Risk assessment and risk management strategies
  • Risk-benefit assessment
  • Risk Communication (e.g., Risk Communication Plans, Risk Communication Tools)
  • Post-market surveillance and Phase IV studies
  • Pharmacovigilance in special populations (e.g., Pediatrics, Geriatrics, Pregnant Women)

Module 6: Pharmacovigilance in Clinical Trials

  • Role of pharmacovigilance in clinical trials
  • Identifying and managing ADRs in clinical trials
  • Pharmacovigilance during Phase I, II, and III trials
  • Good Clinical Practice (GCP) and pharmacovigilance
  • Serious Adverse Events (SAEs) reporting

Module 7: Post-Market Surveillance and Market Authorization

  • Importance of post-marketing surveillance
  • Phases of post-marketing surveillance (Phase IV trials)
  • Real-World Evidence (RWE) and Real-World Data (RWD)
  • Monitoring drug safety after approval

Module 8: Signal Detection and Management

  • Signal detection methodology
  • Statistical methods for signal detection (e.g., Bayesian analysis, disproportionality analysis)
  • Data sources for signal detection (e.g., spontaneous reporting systems, clinical trial data)
  • Signal validation and confirmation

Module 9: Pharmacovigilance Data Management

  • Adverse event reporting systems (e.g., E2B format, FDA’s FAERS, EMA’s EudraVigilance)
  • Tools for data collection and management (e.g., Oracle Argus, Veeva Vault QMS, PV databases)
  • Coding and classification of adverse events (MedDRA, WHO-ART)
  • Data validation and analysis

Module 10: Pharmacovigilance in Different Settings

  • Pharmacovigilance in hospitals, community pharmacies, and clinical settings
  • Role of pharmacists in pharmacovigilance
  • Collaborative efforts between industry and health professionals
  • National and global pharmacovigilance systems

Module 11: Pharmacovigilance and Regulatory Affairs

  • Reporting obligations for pharmaceutical companies and healthcare professionals
  • Good Pharmacovigilance Practices (GVP)
  • Risk communication and product labeling
  • Preparing Periodic Safety Update Reports (PSUR) and Risk Management Plans (RMP)
  • Regulatory compliance and audits in pharmacovigilance

Module 12: Pharmacovigilance Software and Tools

  • Overview of pharmacovigilance software tools (e.g., Oracle Argus, ArisGlobal, Veeva Vault)
  • Electronic reporting systems and the role of technology
  • Data mining tools and signal detection software
  • Reporting adverse events using national and international platforms (e.g., VAERS, WHO's VigiBase)

Module 13: Pharmacovigilance in Drug Development

  • Role of pharmacovigilance in preclinical and clinical development
  • Risk assessments during drug development
  • Safety reporting in clinical trials and during post-marketing
  • Pharmacovigilance roles within pharmaceutical companies

Module 14: Ethics in Pharmacovigilance

  • Ethical considerations in adverse drug reaction reporting
  • Confidentiality and privacy issues in pharmacovigilance
  • Informed consent for reporting adverse events
  • Ethical responsibilities of healthcare professionals

Module 15: Current Trends and Future Directions in Pharmacovigilance

  • Advances in pharmacovigilance techniques (e.g., artificial intelligence, machine learning)
  • The role of social media and patient reporting in pharmacovigilance
  • The impact of big data and electronic health records
  • The future of pharmacovigilance in global healthcare

Assessment and Certification

  • Case studies
  • Assignments and quizzes
  • Practical training (using pharmacovigilance software tools)
  • Final examination or project

Love to hear from you, Get in Touch