Pharmacovigilance in Ensuring Drug Safety and Patient Welfare is a critical resource for healthcare and pharmaceutical professionals, focusing on effective pharmacovigilance practices to detect, assess, and prevent adverse drug effects, thereby enhancing patient safety and ensuring compliance with global regulatory standards.

Aim

The aim of this guide is to empower healthcare and pharmaceutical professionals with advanced pharmacovigilance skills, enhancing their ability to monitor, analyze, and report adverse drug reactions. This knowledge ensures higher drug safety standards, better patient outcomes, and compliance with regulatory requirements, fostering a safer healthcare environment

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Workshop Objectives

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.

Workshop Structure

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

Participant’s Eligibility

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.

Workshop Outcomes

Adverse Drug Reaction Identification: Ability to identify and understand the mechanisms of adverse drug reactions.
Data Analysis Skills: Proficiency in analyzing pharmacovigilance data to discern patterns that indicate potential safety issues.
Reporting and Communication: Skills in accurately documenting and reporting adverse effects as per regulatory standards.
Risk Management: Capability to develop and implement risk management strategies in clinical and pharmaceutical settings.

Mentor Profile

Name: Dr. Bandoo Chhagan Chatale
Designation: Founder and Mentor
Affiliation: Pharmacy Success Hub

Dr. Bandoo Chhagan Chatale is a distinguished figure in the pharmacy sector, celebrated for his visionary and mission-oriented approach. As the founder and mentor of Pharmacy Success Hub since July 2014, he has been a guiding force in empowering pharmacy professionals. He completed his Ph.D. in Pharmaceutical Chemistry from the Institute of Chemical Technology, Mumbai, in September 2020, after obtaining his master’s degree from NIPER, Mohali in June 2014. With a decade of experience in teaching and research, Dr. Chatale specializes in Computer-Aided Drug Design, taste masking, synthesis of small chemical entities, cocrystal formation, and Hot Melt Extrusion (HMT) Technology. His work extends into the innovative realms of Artificial Intelligence in Pharmacy and Healthcare. Dr. Chatale has authored six international research articles and holds a design patent granted by the UK government, marking significant contributions to his field.

Fee Structure

Student

INR. 1399
USD. 50

Ph.D. Scholar / Researcher

INR. 1699
USD. 55

Academician / Faculty

INR. 2199
USD. 60

Industry Professional

INR. 2699
USD. 85

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Future Career Prospects

Director of Pharmacovigilance: Oversee a company’s entire pharmacovigilance department, strategizing drug safety measures and compliance.
Chief Safety Officer: Lead the safety oversight for pharmaceutical products, focusing on risk assessment and mitigation strategies.
Head of Drug Safety Research: Guide research initiatives focused on assessing long-term safety and efficacy of drugs.
Global Pharmacovigilance Manager: Manage and harmonize pharmacovigilance practices across multiple countries, adapting to diverse regulatory landscapes.