Pharmacovigilance for Drug Safety & Efficacy
Ensuring Safer Medicines, Enhancing Patient Care
About This Course
The “Pharmacovigilance for Drug Safety & Efficacy” workshop offers a comprehensive overview of the systems and methodologies used to detect, assess, understand, and prevent adverse effects or other drug-related problems. Over 3 days, participants will delve into the regulatory landscape that governs drug safety, exploring both national and international guidelines. The workshop covers the lifecycle of pharmacovigilance from pre-clinical development to post-market surveillance, emphasizing critical analysis and decision-making based on real-world data.
Aim
This workshop aims to equip participants with the essential skills and knowledge to monitor and evaluate the safety and efficacy of pharmaceuticals. Through a detailed exploration of pharmacovigilance principles and practices, students will learn to identify, assess, and mitigate risks associated with drug use, ensuring public health and compliance with global regulatory standards.
Workshop Objectives
- Understand the principles and scope of pharmacovigilance.
- Learn to identify and report adverse drug reactions effectively.
- Analyze risk-benefit ratios in the context of drug safety.
- Navigate the regulatory requirements for drug safety reporting.
- Apply data analysis tools and techniques in pharmacovigilance.
Workshop Structure
Module 1:
Session 1: Introduction to Pharmacovigilance
● Overview of pharmacovigilance and its significance in the pharmaceutical industry
● Importance of pharmacovigilance in ensuring drug safety and patient welfare
● Regulatory frameworks and guidelines governing pharmacovigilance
Session 2: Adverse Drug Reactions (ADRs)
● Definition and classification of adverse drug reactions
● Identification, assessment, and reporting of ADRs
● Tools and techniques for ADR detection and signal management
Session 3: Pharmacovigilance Databases and Systems
● Introduction to pharmacovigilance databases and their role in data collection and analysis
● Case studies: Analyzing real-world data from pharmacovigilance databases
Session 4: Pharmacovigilance in Clinical Trials
● Role of pharmacovigilance in clinical trial safety monitoring
● Adverse event reporting in clinical trials
● Ethical considerations and patient safety in clinical research
Module 2:
Session 5: Risk Management in Pharmacovigilance
● Overview of risk management strategies in pharmacovigilance
● Risk minimization measures and their implementation
● Pharmacovigilance planning and risk management plans
Session 6: Signal Detection and Management
● Principles of signal detection and signal management
● Tools and methodologies for signal detection and assessment
● Case studies: Analyzing and managing safety signals
Session 7: Pharmacovigilance Audits and Inspections
● Overview of pharmacovigilance audits and inspections
● Preparation and compliance for pharmacovigilance audits
● Ensuring quality and regulatory compliance in pharmacovigilance
Module 3:
Session 8: Pharmacovigilance in Special Populations
● Pharmacovigilance considerations in special populations (pediatrics, geriatrics, pregnant women, etc.)
● Monitoring and reporting adverse events in vulnerable populations
● Case studies: Addressing pharmacovigilance challenges in special populations
Session 9: Pharmacovigilance Communication and Reporting
● Effective communication of drug safety information to healthcare professionals and the public
● Regulatory reporting requirements and timelines
● Practical exercises: Preparing pharmacovigilance reports and communication materials
Session 10: Emerging Trends and Future Directions in Pharmacovigilance
● Latest advancements and technologies in pharmacovigilance
● Digital pharmacovigilance and the role of artificial intelligence
● Discussion on future challenges and opportunities in pharmacovigilance
Who Should Enrol?
- Undergraduate degree in Pharmacy, Nursing, Medicine, or related health sciences.
- Professionals in pharmaceutical, biotechnology, or clinical research organizations.
- Individuals passionate about improving drug safety and patient care.
Workshop Outcomes
- Mastery of drug safety monitoring techniques
- Enhanced ability to comply with international drug safety laws
- Skills in managing drug-related risks
- Expertise in adverse effect analysis and reporting
- Preparedness for leadership roles in pharmacovigilance
Fee Structure
Standard: ₹3,998 | $100
Discounted: ₹1999 | $50
What You’ll Gain
- Live & recorded sessions
- e-Certificate upon completion
- Post-workshop query support
- Hands-on learning experience
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