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PHARMACOVIGILANCE AND PATIENT SAFETY

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Comprehensive Short Course on Pharmacovigilance and Patient Safety
Total Duration: 50 hours
Live Online Sessions: 24 hours
Self-Paced Learning: 12 hours
Assessments & Project: 14 hours
Training Fee: Contact for pricing
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Pharmacy & Patient Safety

COMPREHENSIVE SHORT COURSE ON PHARMACOVIGILANCE AND PATIENT SAFETY

( 5.0 )
Overview

The Comprehensive Short Course in Pharmacovigilance and Patient Safety is a multidisciplinary program designed to equip healthcare professionals, regulatory officers, and industry stakeholders with the knowledge and skills required for effective medicine safety surveillance and patient protection. Pharmacovigilance (PV) is a critical component of public health, ensuring that medicines are used safely and effectively.

ICT Requirements

  • Computer/Laptop with Microphone & Camera in working condition
  • Good Internet connection
  • Access to Google Forms/MS Forms
  • Ability to perform basic MS Word and Excel functions
Learning Outcomes

Upon successful completion of this course, participants will be able to:

  • Explain the fundamental principles and global frameworks of pharmacovigilance
  • Detect, assess, and report adverse drug reactions accurately and efficiently
  • Analyze safety data to identify signals and contribute to regulatory actions
  • Implement pharmacovigilance systems in hospitals, communities, and public health programs
  • Apply risk management, quality assurance, and compliance strategies in PV practice
  • Use digital tools and databases for PV data management and decision-making
  • Demonstrate leadership, accountability, and regulatory responsibility in medicine safety
Assessment

Throughout the training program, various assessment techniques will be employed:

Pre-Test: Baseline knowledge assessment

Continuous Assessment: Weekly quizzes and participation in theoretical and practical sessions

Case Study Analysis: Real-world scenarios for practical application

Capstone Project Evaluation: Comprehensive final project presentation

Post-Test: Comprehensive final evaluation

Passing Criteria

To qualify for a certificate of competence, candidates must achieve a minimum passing score of 80% or above on the post-test administered at the end of the training.

Target Audience

This course is designed for healthcare professionals, regulatory officers, pharmaceutical industry stakeholders, and individuals interested in pharmacovigilance and regulatory affairs.

Training Modality

Delivery Mode: Blended learning, Online live sessions, LMS for self-paced content.

Live Sessions: Conducted via Google Meet on Mondays and Wednesdays, 2 hours per session over 6 weeks (12 sessions total).

Curriculum
Course Description

This introductory module provides the foundation for understanding pharmacovigilance as a critical aspect of patient safety and public health. It explores the origin, purpose, and structure of global and national PV systems, introduces key concepts such as adverse drug reactions and adverse events, and highlights the multidisciplinary nature of pharmacovigilance.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the role of pharmacovigilance in healthcare systems
  • Identify and differentiate between ADRs, AEs, and medication errors
  • Outline the global pharmacovigilance framework and its stakeholders
  • Describe the structure and function of national pharmacovigilance programs
  • Demonstrate basic competence in completing an ADR report
Contents to Cover
  • Overview of Pharmacovigilance: Definition, objectives, and scope
  • Historical Evolution of PV: Key milestones and drug safety crises
  • Global and Regional PV Frameworks: WHO-UMC, EMA, FDA, MHRA systems
  • Core Concepts and Terminologies: ADRs, AEs, medication errors, signal detection
  • Roles and Responsibilities in PV: Healthcare professionals, patients, and institutions
  • Ethical and Legal Basis of PV: Regulatory obligations and good pharmacovigilance practice
Course Description

This module focuses on understanding the nature, types, and mechanisms of adverse drug reactions and adverse events. Participants will learn how to detect, evaluate, and prevent ADRs using standardized tools and frameworks.

Learning Outcomes

By the end of this module, participants will be able to:

  • Define and distinguish ADRs from adverse events and medication errors
  • Describe the classification and mechanisms of ADRs
  • Identify high-risk drugs and patient populations for ADRs
  • Apply causality assessment principles to ADR identification
  • Implement preventive and management strategies for ADRs in clinical settings
Contents to Cover
  • Introduction to Adverse Drug Reactions (ADRs): Definitions and distinctions
  • Classification of ADRs: Type A, B, C, D, E, F with clinical examples
  • Mechanisms of ADRs: Pharmacological, immunological, genetic, and idiosyncratic
  • Risk Factors for ADRs: Patient-related, drug-related, environmental factors
  • Detection, Prevention, and Management of ADRs: Clinical identification and monitoring
  • Documentation and Reporting of ADRs: Steps in ADR reporting process
  • Case Studies and Practical Exercises: Analysis of historical ADR events
Course Description

This module provides an in-depth understanding of spontaneous reporting systems as the backbone of pharmacovigilance. Participants will explore how national and international PV systems function, the processes of ADR reporting, and the role of data aggregation and analysis in identifying safety signals.

Learning Outcomes

By the end of this module, participants will be able to:

  • Describe the key elements and workflow of spontaneous reporting systems
  • Identify appropriate tools and forms for ADR reporting
  • Complete and submit ADR reports accurately and promptly
  • Understand how reported data contribute to signal detection and regulatory action
  • Promote a culture of pharmacovigilance and reporting within their institutions
Contents to Cover
  • Introduction to Spontaneous Reporting Systems: Definition, purpose, and importance
  • Structure and Function of National Pharmacovigilance Centers: Organization and roles
  • ADR Reporting Tools and Platforms: National forms, WHO-UMC Vigiflow and VigiBase
  • Reporting Process and Best Practices: Who should report and when to report
  • Barriers and Strategies to Improve Reporting: Common obstacles and motivation approaches
  • Use of Spontaneous Reporting Data: Aggregation, analysis, and impact on regulatory decisions
  • Case Studies and Practical Exercises: Simulation of ADR reporting using national forms
Course Description

This module provides participants with an in-depth understanding of how to determine whether an adverse event is caused by a drug and how to identify potential safety signals from pharmacovigilance data.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the concept and purpose of causality assessment in pharmacovigilance
  • Apply established algorithms for assessing drug-event relationships
  • Interpret pharmacovigilance data to identify safety signals
  • Understand the process of signal validation and prioritization
  • Communicate and document signal findings in accordance with best practice guidelines
Contents to Cover
  • Introduction to Causality Assessment: Definition, purpose, and importance
  • Methods and Tools for Causality Assessment: WHO-UMC system, Naranjo algorithm
  • Practical Application of Causality Assessment: Case-based exercises
  • Introduction to Signal Detection: Definition and objectives
  • Methods and Tools for Signal Detection: Quantitative and qualitative methods
  • Signal Validation, Assessment, and Prioritization: Criteria and steps in evaluation
  • Case Studies and Exercises: Review of real-world safety signals
Course Description

This module introduces the principles and practices of pharmacovigilance risk management and safety communication. It focuses on identifying medicine-related risks, developing structured risk management plans, and implementing risk minimization strategies.

Learning Outcomes

By the end of this module, participants will be able to:

  • Define and describe the components of risk management in pharmacovigilance
  • Develop and evaluate a Risk Management Plan (RMP)
  • Apply risk minimization tools and strategies in clinical and regulatory contexts
  • Communicate safety information effectively during routine monitoring and crises
  • Contribute to a culture of proactive risk management and patient safety
Contents to Cover
  • Introduction to Risk Management in Pharmacovigilance: Definition and objectives
  • Risk Management Plans (RMPs): Structure, content, and regulatory requirements
  • Risk Identification, Evaluation, and Mitigation: Methods and tools
  • Safety Communication in Pharmacovigilance: Principles and examples
  • Crisis Communication and Media Management: Handling safety crises
  • Roles and Responsibilities in Risk Management: Collaboration among stakeholders
  • Case Studies and Practical Exercises: Real-world examples of risk communication
Course Description

This module focuses on the operationalization of pharmacovigilance within hospital settings. It explores strategies for establishing effective PV systems, integrating reporting into clinical workflows, and ensuring collaboration between hospital departments.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the structure and importance of hospital-based pharmacovigilance systems
  • Identify and report ADRs effectively within clinical settings
  • Integrate PV activities with hospital governance and quality assurance mechanisms
  • Engage hospital committees in promoting medicine safety and rational drug use
  • Develop an institutional plan to enhance ADR reporting and feedback
Contents to Cover
  • Introduction to Hospital Pharmacovigilance: Definition and significance
  • Establishing a Hospital Pharmacovigilance Unit: Organizational structure and SOPs
  • Detection and Reporting of ADRs in Hospitals: Identification during ward rounds
  • Integration of PV into Hospital Committees and Systems: Collaboration with DTCs
  • Training and Sensitization of Hospital Staff: Capacity building approaches
  • Challenges and Opportunities in Hospital PV: Barriers and best practices
  • Case Studies and Practical Exercises: Simulation of hospital ADR reporting
Course Description

This module explores the practice of pharmacovigilance in community pharmacies, clinics, and public health programs. It covers systems for detecting and reporting ADRs in non-hospital environments and highlights how pharmacovigilance contributes to the safety of mass treatment and immunization programs.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the significance of community-based pharmacovigilance in promoting patient safety
  • Identify and report ADRs and other medicine-related problems from community settings
  • Integrate PV practices into public health programs such as HIV, TB, malaria, and immunization
  • Design and implement community awareness and reporting campaigns
  • Strengthen linkages between community-based PV structures and national regulatory authorities
Contents to Cover
  • Introduction to Community Pharmacovigilance: Scope and importance
  • Roles of Stakeholders in Community PV: Pharmacists, nurses, community health volunteers
  • Public Health Program Pharmacovigilance: Integration into disease-specific programs
  • Tools and Procedures for Community-Based ADR Reporting: Forms and mobile platforms
  • Community Engagement and Awareness Creation: Educating the public on safe medicine use
  • Designing a Community PV System: Steps in establishing community PV networks
  • Case Studies and Practical Exercises: Simulation of ADR detection in retail pharmacy
Course Description

This module explores the importance of pharmacovigilance in monitoring medicine safety for populations with special physiological or clinical characteristics and for products with unique mechanisms or formulations.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the rationale for specialized pharmacovigilance approaches in vulnerable populations
  • Identify and manage safety issues related to pediatric, geriatric, and pregnant populations
  • Conduct pharmacovigilance for vaccines, biologics, and herbal products
  • Recognize and report adverse events related to medical devices and cosmetics
  • Contribute to national safety monitoring initiatives for diverse therapeutic products
Contents to Cover
  • Introduction to Pharmacovigilance in Special Populations: Definition and categories
  • Pharmacovigilance in Pediatric and Geriatric Populations: ADR patterns and considerations
  • Pharmacovigilance in Pregnancy and Lactation: Drug safety considerations
  • Vaccine Pharmacovigilance and AEFI Monitoring: Vaccine safety systems
  • Biologics and Biosimilars: Unique safety challenges and regulatory requirements
  • Herbal and Traditional Medicines Vigilance: Common ADRs and safety issues
  • Medical Devices and Cosmetics Vigilance: Adverse event reporting
  • Case Studies and Practical Exercises: Real-world examples of safety monitoring
Course Description

This module provides a detailed overview of the Qualified Person for Pharmacovigilance (QPPV) role, which is central to the governance and accountability of pharmacovigilance systems.

Learning Outcomes

By the end of this module, participants will be able to:

  • Explain the regulatory background and purpose of the QPPV role
  • Describe the key responsibilities and decision-making authority of QPPVs
  • Understand the structure and content of a Pharmacovigilance System Master File (PSMF)
  • Apply QPPV principles in managing safety data, audits, and inspections
  • Promote organizational compliance and leadership in pharmacovigilance governance
Contents to Cover
  • Introduction to the QPPV Role: Definition and background
  • Regulatory Requirements and Global Standards: QPPV obligations under various frameworks
  • Roles and Responsibilities of the QPPV: Oversight of pharmacovigilance systems
  • QPPV in Governance and Compliance: Ensuring continuous compliance with GVP
  • Pharmacovigilance System Master File (PSMF): Structure, components, and maintenance
  • QPPV Leadership and Communication: Effective communication with regulatory authorities
  • Challenges and Future Directions for QPPVs: Common challenges and emerging trends
  • Case Studies and Practical Exercises: Real-world examples of QPPV-led safety decisions
Course Description

This module introduces participants to the principles and practices of pharmacovigilance data management. It focuses on data collection, validation, storage, analysis, and reporting using both manual and electronic systems.

Learning Outcomes

By the end of this module, participants will be able to:

  • Understand the workflow of data collection, entry, and submission in PV systems
  • Use appropriate tools and databases for ADR reporting and analysis
  • Apply MedDRA coding and E2B reporting standards correctly
  • Interpret PV data to support signal detection and risk assessment
  • Maintain confidentiality and data security in PV activities
Contents to Cover
  • Introduction to Pharmacovigilance Data Management: Overview and importance
  • Pharmacovigilance Information Systems and Databases: Global and regional databases
  • Electronic Data Standards and Formats: ICH E2B(R3) and MedDRA terminology
  • Data Collection and Quality Management: Data sources and verification
  • Data Analysis and Interpretation: Quantitative and qualitative methods
  • Data Confidentiality and Security: Ethical considerations and data protection
  • Integration of PV Data into Decision-Making: Linking PV data to risk management
  • Case Studies and Practical Exercises: Data entry and validation exercises
Course Description

This module focuses on strengthening pharmacovigilance systems through structured quality assurance and performance monitoring. It provides participants with tools and methodologies to assess PV system functionality, identify gaps, implement corrective actions, and ensure compliance with international best practices.

Learning Outcomes

By the end of this module, participants will be able to:

  • Describe essential components of an effective PV system
  • Conduct systematic evaluation and benchmarking of PV performance
  • Apply QA principles to ensure PV data reliability and regulatory compliance
  • Develop and implement internal audits and improvement plans
  • Design sustainable strategies for system strengthening and stakeholder engagement
Contents to Cover
  • Overview of Pharmacovigilance System Strengthening: Concept and importance
  • Components of a Functional PV System: Core structures and interlinkages
  • Quality Assurance in Pharmacovigilance: Definition, scope, and importance
  • PV System Audits and Inspections: Internal and external audit processes
  • Performance Indicators and Monitoring Tools: Key performance indicators (KPIs)
  • Continuous Improvement Strategies: Risk-based approaches to system strengthening
  • Governance and Sustainability: Role of leadership in sustaining PV systems
  • Case Studies and Practical Exercises: Real-world examples of PV system improvement
Course Description

This module provides an in-depth understanding of pharmacovigilance auditing, inspection, and compliance frameworks. It focuses on the principles of internal and external audits, regulatory inspection processes, and strategies for ensuring compliance with national and international PV regulations.

Learning Outcomes

By the end of this module, participants will be able to:

  • Distinguish between the purposes and processes of PV audits and inspections
  • Demonstrate knowledge of global PV compliance standards and GVP modules
  • Prepare effectively for PV audits and inspections
  • Develop and implement CAPA plans to address non-conformities
  • Contribute to continuous PV system improvement and regulatory accountability
Contents to Cover
  • Introduction to Pharmacovigilance Auditing and Inspection: Definitions and objectives
  • Regulatory Framework for PV Compliance: Global PV regulations and legal obligations
  • Audit and Inspection Processes: Audit life cycle and regulatory inspection workflow
  • Inspection Readiness and Management: Preparing for announced and unannounced inspections
  • Common Findings and Compliance Issues: Typical audit/inspection deficiencies
  • Corrective and Preventive Actions (CAPA): Developing and implementing CAPA plans
  • Quality Management and Continuous Improvement: Integrating audit findings
  • Case Studies and Practical Exercises: Mock pharmacovigilance inspection
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