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Long Courses

Advanced Pharmacovigilance: Ensuring Drug Safety in Clinical Research

Advanced Pharmacovigilance, Drug Safety Clinical Research, Pharmacovigilance Systems, Adverse Drug Reactions, Clinical Trials, Pharmacovigilance Plans

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MODE
Virtual (Google Meet)

TYPE
Self Paced

LEVEL
Moderate

DURATION
3 Months

VIDEO LENGTH
1

About

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring that medicines are safe and effective, by monitoring the effects of pharmaceuticals after they have been licensed for use. This field involves the collection and analysis of data from patients and healthcare providers to identify new information about hazards associated with medicines and prevent harm to patients. Key components of pharmacovigilance include adverse drug reaction reporting, safety signal detection, risk management, and communication. It aims to improve patient care and safety, contribute to the assessment of benefit, harm, effectiveness, and risk of medicines, and promote the safe, rational, and more effective use of medicines.

Aim

This program aims to provide participants with an in-depth understanding of pharmacovigilance principles, practices, and regulatory requirements in the context of clinical research. Participants will learn how to effectively monitor and evaluate drug safety data, detect adverse events, and contribute to patient safety throughout the drug development lifecycle.

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Short Courses Objectives

Understand the fundamental principles and concepts of pharmacovigilance in clinical research.
Learn the regulatory requirements and guidelines governing pharmacovigilance activities.
Gain knowledge of adverse event reporting and management, including signal detection, causality assessment, and risk-benefit evaluation.
Develop skills in pharmacovigilance data collection, analysis, and reporting using standardized tools and databases.
Understand the role of pharmacovigilance in post-marketing surveillance and risk management of medicinal products.

Short Courses Structure

Week 1: Introduction to Pharmacovigilance

Overview of pharmacovigilance and its significance in clinical research

Historical background and evolution of pharmacovigilance practices

Week 2: Pharmacovigilance Regulatory Framework

International regulations and guidelines governing pharmacovigilance

Role of regulatory authorities and their expectations for compliance

Week 3: Adverse Event Reporting and Signal Detection

Adverse event classification, coding, and reporting requirements

Signal detection methods and tools for identifying safety concerns

Week 4: Pharmacovigilance Databases and Systems

Overview of pharmacovigilance databases (e.g., VigiBase) and their use

Case management systems and electronic reporting platforms

Week 5: Risk Assessment and Benefit-Risk Evaluation

Principles of risk assessment and benefit-risk evaluation in pharmacovigilance

Decision-making processes for regulatory actions and risk management plans

Week 6: Safety Data Exchange and Collaboration

International safety data exchange programs and initiatives

Collaborative pharmacovigilance networks and their benefits

Week 7: Pharmacovigilance Audits and Inspections

Preparing for pharmacovigilance audits and regulatory inspections

Best practices for maintaining compliance and inspection readiness

Week 8: Pharmacovigilance in Clinical Trials

Adverse event reporting in clinical trials and safety monitoring practices

Investigator responsibilities and sponsor obligations in pharmacovigilance

Week 9: Pharmacovigilance in Post-Marketing Surveillance

Post-marketing safety studies and real-world data collection
Risk management strategies and pharmacovigilance in post-approval phase

Week 10: Signal Management and Risk Communication

Signal management processes and assessment of emerging safety concerns

Effective risk communication to healthcare professionals and the public

Week 11: Pharmacovigilance Quality Management

Quality management systems and pharmacovigilance quality indicators

Ensuring quality and continuous improvement in pharmacovigilance activities

Week 12: Pharmacovigilance Future Trends and Closing Remarks

Emerging trends and technologies in pharmacovigilance

Recapitulation of key concepts and closing remarks

Participant’s Eligibility

Graduates, Post Graduates, Research Scholars, Academicians, Industry Professionals of Pharmaceutical, Clinical Research Organizations, Healthcare Institutions

Short Courses Outcomes

Comprehensive understanding of pharmacovigilance principles and practices in clinical research.
Knowledge of regulatory requirements and guidelines governing pharmacovigilance.
Proficiency in adverse event reporting, signal detection, and risk-benefit evaluation.
Skills in pharmacovigilance data collection, analysis, and reporting.
Competence in post-marketing surveillance and risk management of medicinal products.

Fee Structure

We are excited to announce that we now accept payments in over 20 global currencies, in addition to USD. Check out our list to see if your preferred currency is supported. Enjoy the convenience and flexibility of paying in your local currency!

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