New Year Offer End Date: 30th April 2024
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Pharmacovigilance for Drug Safety & Efficacy

“Ensuring Safety and Quality: Navigating Pharmacovigilance in the Pharmaceutical Industry”

About Program:

The “Overview of Pharmacovigilance relevant to Pharmaceutical Industry Program” is a comprehensive and insightful event designed to provide a thorough understanding of pharmacovigilance within the pharmaceutical industry. This program aims to empower professionals by equipping them with the knowledge and tools necessary to navigate the complex landscape of drug safety monitoring and reporting. Participants will delve into the fundamental principles of pharmacovigilance, gaining insights into adverse drug reactions, signal detection, risk assessment, and regulatory requirements.

Aim: The aim of the “Pharmacovigilance for Drug Safety & Efficacy Program” is to provide participants with a comprehensive understanding of pharmacovigilance and its significance in the pharmaceutical industry.

Program Objectives:

  1. Understanding the Principles of Pharmacovigilance: To provide participants with a scientific foundation and understanding of the principles that govern pharmacovigilance, including the detection, assessment, and prevention of adverse drug reactions.
  2. Exploring Pharmacovigilance Data Analysis: To introduce participants to the scientific methods and techniques used in analyzing pharmacovigilance data, enabling them to identify safety signals and assess the risks associated with medicinal products.
  3. Examining the Role of Pharmacovigilance in Drug Safety Monitoring: To explore the role of pharmacovigilance in the post-marketing surveillance of drugs, including the systematic collection and analysis of safety data to ensure the ongoing assessment of their safety profile.
  4. Understanding Signal Detection and Management: To familiarize participants with the scientific approaches and methodologies employed in signal detection and management, including the identification, evaluation, and prioritization of potential safety signals.
  5. Assessing Risk-Benefit Profiles: To enable participants to understand the scientific basis of assessing the risk-benefit profiles of medicinal products, considering both the potential benefits and risks associated with their use.
  6. Exploring Pharmacovigilance Regulations and Guidelines: To provide participants with an understanding of the scientific basis underlying pharmacovigilance regulations and guidelines, enabling them to interpret and apply them appropriately in their professional roles.
  7. Investigating Emerging Trends in Pharmacovigilance: To explore the scientific advancements and emerging trends in the field of pharmacovigilance, including the application of artificial intelligence, big data analytics, and real-world evidence in drug safety monitoring.
  8. Analyzing Pharmacovigilance Case Studies: To engage participants in scientific discussions and analysis of pharmacovigilance case studies, allowing them to critically evaluate and apply scientific principles in practical scenarios.
  9. Promoting Scientific Rigor in Reporting and Documentation: To emphasize the importance of accurate and comprehensive scientific reporting and documentation in pharmacovigilance, ensuring the integrity and reliability of safety data.
  10. Encouraging Scientific Collaboration and Research: To foster a scientific culture of collaboration and research in pharmacovigilance, encouraging participants to explore scientific inquiry, contribute to the literature, and engage in evidence-based practices.

What you will learn?

Day 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

Day 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

Day 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

Fee Plan

INR 1999 /- OR USD 50

Intended For : Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals of Pharmaceutical Sciences, Pharmacology, Pharmacy, Pharmaceutical Industry

Career Supporting Skills

Pharmacovigilance Documentation Good Pharmacovigilance Practices (GVP) Pharmacovigilance Risk Assessment and Benefit-Risk Analysis Pharmacovigilance Data Analysis Pharmacovigilance Quality Management

Program Outcomes

  1. Proficiency in Pharmacovigilance Data Analysis: Participants will develop scientific skills in analyzing pharmacovigilance data, identifying safety signals, and assessing the risks associated with medicinal products using scientific approaches and statistical methods.
  2. Expertise in Signal Detection and Management: Participants will acquire scientific expertise in detecting, evaluating, and managing safety signals, applying scientific methodologies to prioritize signals and determine appropriate risk mitigation strategies.
  3. Knowledge of Pharmacovigilance Regulations and Guidelines: Participants will gain a scientific understanding of pharmacovigilance regulations and guidelines, allowing them to interpret and apply them in a scientifically rigorous manner.
  4. Ability to Assess Risk-Benefit Profiles: Participants will be able to scientifically assess the risk-benefit profiles of medicinal products, considering scientific evidence and applying scientific principles to evaluate the potential benefits and risks.
  5. Familiarity with Scientific Reporting and Documentation: Participants will develop scientific proficiency in reporting and documenting pharmacovigilance data, ensuring accuracy, reliability, and scientific integrity in their reports and documentation.
  6. Awareness of Emerging Scientific Trends: Participants will stay informed about emerging scientific trends in pharmacovigilance, such as the integration of real-world evidence, big data analytics, and artificial intelligence, enabling them to stay updated with the latest scientific advancements.
  7. Competence in Pharmacovigilance Research: Participants will have the scientific knowledge and skills to engage in pharmacovigilance research, contributing to the scientific literature and advancing knowledge in the field.