Pharmaceutical Industry Pharmacovigilance & Drug Safety

Pharmacovigilance & Drug Safety: Unlocking the Secrets to Ensuring Medication Safety Worldwide

What you'll learn

Introduction to Pharmacovigilance: Understanding the importance and objectives of pharmacovigilance in ensuring drug safety.

Historical Perspective: Incidents that led to the evolution and development of pharmacovigilance.

Regulatory Framework: An overview of global pharmacovigilance regulations and guidelines, including those by the World Health Organization (WHO) and the Interna

Adverse Drug Reactions (ADR) Reporting: The process and significance of reporting ADRs, understanding spontaneous reports.

Signal Detection: Methods and tools used in signal detection and the significance of identifying new safety concerns.

Risk Management: Strategies and tools used in assessing and minimizing risks associated with drug use.

Post-Marketing Surveillance: Strategies used to monitor the safety of a drug after it has been approved and is in the market.

Requirements

There Are No Requirements Necessary To Enroll. I Only Ask To Come Open-Minded And Ready To Learn.

Description

Pharmacovigilance, the science of detecting, assessing, understanding, and preventing adverse effects or any drug-related problem, is a cornerstone of patient safety. This comprehensive course offers a deep dive into the world of drug safety, ensuring that healthcare professionals, researchers, and stakeholders are equipped with the latest knowledge and best practices.Key Learning Outcomes:Foundations of Pharmacovigilance: Traverse the history and significance of pharmacovigilance, understanding its pivotal role in global health.Regulatory Landscape: Explore the international guidelines, regulations, and authorities that shape drug safety surveillance.Adverse Drug Reactions (ADR) and Reporting: Gain insights into the identification, documentation, and reporting of ADRs, enhancing patient safety.Signal Detection & Risk Management: Master the tools and techniques for signal detection and develop strategies to assess and mitigate drug risks.Real-world Pharmacovigilance: Delve into post-marketing surveillance, patient support programs, and the role of big data in monitoring drug safety.Ethics & Challenges: Address the ethical considerations in pharmacovigilance and explore the dynamic challenges and future prospects of the field.Whether you're a healthcare professional aiming to enhance patient safety, a researcher keen on understanding drug effects in populations, or simply a curious learner, this course will equip you with the expertise to navigate the intricate and ever-evolving world of pharmacovigilance. Join us on this enlightening journey and be at the forefront of global medication safety.

Overview

Section 1: Introduction to Pharmacovigilance and Drug Safety

Lecture 1 Introduction

Lecture 2 Partners in Pharmacovigilance and Drug Safety Monitoring

Lecture 3 National Pharmacovigilance Centers Role in ADRs Reporting

Section 2: Good Pharmacovigilance Practices

Lecture 4 Introduction and Principles

Lecture 5 Pharmacovigilance Quality Management Systems

Lecture 6 Significances and impacts of Pharmacovigilance Quality Management Systems

Lecture 7 Pharmacovigilance System Master File and Pharmacovigilance Inspections

Lecture 8 Pharmacovigilance Audit and Risk Management

Lecture 9 Collection, Management and Submission of Report

Lecture 10 Periodic Safety Update Report

Lecture 11 Post-Authorization Safety Study

Lecture 12 Signal Management and Additional Monitoring

Lecture 13 Safety Communication

Lecture 14 Risk Minimization Measures

Section 3: Signals

Lecture 15 Signals and Signals Identification

Lecture 16 Methods of Signals Identification

Lecture 17 Strengthening the Signal

Lecture 18 Pharmacovigilance Indicators

Lecture 19 Relationships and Causality Assessment

Lecture 20 WHO-UMC Causality Assessment System

Lecture 21 Algorithmic Methods for Causality Assessment

Section 4: Pharmacovigilance Surveillance and Methods

Lecture 22 Pharmacovigilance Surveillance and Methods Used for Drug Safety Monitoring

Lecture 23 Spontaneous Reporting

Lecture 24 WHO Criteria for Spontaneous Reporting

Lecture 25 Cohort Event Monitoring (Part 1)

Lecture 26 Cohort Event Monitoring (Part 2)

Lecture 27 Difference between Cohort Event Monitoring and Spontaneous Reporting

Lecture 28 Drug Safety Monitoring - Developing a Consumer Reporting System

Lecture 29 Drug Safety Monitoring: Components of a Report And the Method of Reporting

Section 5: Risk Management

Lecture 30 Risk Factors

Lecture 31 Premarket Benefit-Risk Assessment

Lecture 32 Postmarket Benefit-Risk Assessment

The Ideal Student For This Course Is Anyone Who Wants To Learn About 'Pharmacovigilance' Or An Existing Professional Who Wants To Expand On Their Current Skills.