• Understand Pharmacovigilance Principles: Gain a deep understanding of the fundamental principles of pharmacovigilance, including its scope and significance in healthcare.
• Enhance Drug Safety Monitoring: Learn techniques for effectively monitoring and reporting adverse drug reactions to improve drug safety.
• Promote Patient Safety: Emphasize the implementation of strategies that ensure patient safety and minimize risks associated with medication use.
• Support Regulatory Compliance: Provide knowledge on current regulatory requirements and how to comply with them to ensure the efficacy and safety of drugs.

Day 1 :

Session 1: Introduction to Pharmacovigilance
● Overview and Importance of Pharmacovigilance
○ Definition and objectives
○ Importance in ensuring drug safety and patient welfare

Session 2: Adverse Drug Reactions (ADRs)
● Definition, Classification, Identification, Assessment, and Reporting of ADRs
○ Types of ADRs
○ Methods for identification and assessment
○ Reporting mechanisms and regulatory requirements

Session 3: Tools and Techniques for ADR Detection and Signal Management
● Tools and methodologies for ADR detection
● Signal management principles and techniques
● Case Studies: Analyzing and managing safety signals

Day 2:

Session 4: Pharmacovigilance in Clinical Trials
● Role of Pharmacovigilance in Clinical Trial Safety Monitoring
○ Adverse event reporting in clinical trials
○ Risk management strategies and minimization measures
● Pharmacovigilance Planning and Risk Management Plans
Session 5: Signal Detection and Risk Management
● Principles of Signal Detection and Signal Management
○ Tools and methodologies for signal detection and assessment
○ Case Studies: Analyzing and managing safety signals

Session 6: Pharmacovigilance Audits, Inspections, and Special Populations

• Overview of Pharmacovigilance Audits and Inspections
  ● Pharmacovigilance Considerations in Special Populations

Day 3:

Session 7: Recent Advancements in Pharmacovigilance

• Overview of Recent Advancements
  ○ Real-world evidence and big data analytics
  ○ Artificial intelligence and machine learning applications
  ○ Integration of electronic health records (EHRs) and patient-reported outcomes
  ○ Global pharmacovigilance harmonization efforts

Session 8: Communication and Reporting

• Effective Communication of Drug Safety Information
  ○ To healthcare professionals and the public
  ● Practical Exercises: Preparing Pharmacovigilance Reports and Communication
  Materials
  Session 9: Future of Pharmacovigilance
• Digital Pharmacovigilance and the Role of Artificial Intelligence
  ● Discussion on Future Challenges and Opportunities in Pharmacovigilance

• Students: Undergraduate and graduate students in pharmacy, medicine, and health sciences interested in drug safety and pharmacovigilance.
• PhD Scholars: Researchers studying drug interactions, adverse effects, or any pharmacological aspects that directly impact patient care.
• Academicians: Faculty members teaching pharmacology, clinical medicine, or pharmacy who integrate pharmacovigilance into their curriculum.
• Industry Professionals: Healthcare professionals, regulatory affairs specialists, and pharmaceutical industry personnel involved in drug safety monitoring.