About

The Certificate Course in Pharmacovigilance offers an in-depth exploration into the critical role of drug safety monitoring in the healthcare industry. Throughout this month-long program, participants will engage with the fundamental concepts of pharmacovigilance, including adverse event reporting, risk management, and data analysis. The course is designed to blend theoretical knowledge with practical skills through case studies, regulatory document reviews, and real-world data evaluation exercises.

Aim

This program aims to provide comprehensive training in pharmacovigilance principles and practices, focusing on the monitoring, assessment, and prevention of adverse effects associated with pharmaceutical products. Participants will learn to ensure drug safety and compliance with global regulatory standards, enhancing patient care and public health outcomes

Objectives

• Develop a robust understanding of pharmacovigilance systems and their importance in healthcare.
• Learn to effectively manage and report adverse drug reactions.
• Understand global regulatory requirements and how to comply with them.
• Analyze real-world evidence and case reports to improve drug safety.
• Enhance skills in communication and collaboration with regulatory bodie.

Curriculum

1. Week 1: Introduction to Pharmacovigilance and Drug Safety

   • Definition, objectives, and global importance of pharmacovigilance
   • Historical evolution and landmark drug safety incidents
   • Types and classification of adverse drug reactions (ADRs)
   • Overview of drug development lifecycle and regulatory checkpoints

2. Week 2: ADR Reporting Systems and Regulatory Frameworks

   • Spontaneous reporting systems: WHO-UMC, Vigibase, MedWatch
   • Pharmacovigilance guidelines (ICH, EMA, CDSCO, FDA)
   • Signal detection and risk assessment methods
   • Data mining techniques in safety surveillance

3. Week 3: Advanced Pharmacovigilance Tools and Technology

   • Case processing and narrative writing (ICSRs, PSURs)
   • Pharmacovigilance software: Argus, ARISg, Veeva Vault Safety
   • Integration of AI, machine learning, and automation in drug safety
   • Data visualization and dashboards for safety signal analytics

4. Week 4: Career Pathways, Compliance, and Future Trends

   • Roles in PV: Drug safety associate, quality reviewer, risk assessor
   • Audit, inspection readiness, and pharmacovigilance compliance
   • Global outsourcing and PV operations in India
   • Emerging trends: Real-world evidence, mobile reporting apps, and predictive PV models

Outcomes

• Expert knowledge of pharmacovigilance protocols and practices.9764-scaled
• Ability to navigate and comply with international drug safety regulations.
• Proficiency in adverse event reporting and risk assessment
• Skills in data analysis and interpretation for drug safety
• Collaboration and communication skills with regulatory authorities