Pharmaceutical Industry Pharmacovigilance & Drug Safety

Pharmaceutical Industry Pharmacovigilance & Drug Safety, available at $29.99, has an average rating of 4.58, with 32 lectures, based on 93 reviews, and has 267 subscribers.

You will learn about 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. This course is ideal for individuals who are 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. It is particularly useful for 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.

Enroll now: Pharmaceutical Industry Pharmacovigilance & Drug Safety

Summary

Title: Pharmaceutical Industry Pharmacovigilance & Drug Safety

Price: $29.99

Average Rating: 4.58

Number of Lectures: 32

Number of Published Lectures: 32

Number of Curriculum Items: 32

Number of Published Curriculum Objects: 32

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will 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.

Who Should Attend

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.

Target Audiences

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.

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.

Course Curriculum

Chapter 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

Chapter 2: Good Pharmacovigilance Practices

Lecture 1: Introduction and Principles

Lecture 2: Pharmacovigilance Quality Management Systems

Lecture 3: Significances and impacts of Pharmacovigilance Quality Management Systems

Lecture 4: Pharmacovigilance System Master File and Pharmacovigilance Inspections

Lecture 5: Pharmacovigilance Audit and Risk Management

Lecture 6: Collection, Management and Submission of Report

Lecture 7: Periodic Safety Update Report

Lecture 8: Post-Authorization Safety Study

Lecture 9: Signal Management and Additional Monitoring

Lecture 10: Safety Communication

Lecture 11: Risk Minimization Measures

Chapter 3: Signals

Lecture 1: Signals and Signals Identification

Lecture 2: Methods of Signals Identification

Lecture 3: Strengthening the Signal

Lecture 4: Pharmacovigilance Indicators

Lecture 5: Relationships and Causality Assessment

Lecture 6: WHO-UMC Causality Assessment System

Lecture 7: Algorithmic Methods for Causality Assessment

Chapter 4: Pharmacovigilance Surveillance and Methods

Lecture 1: Pharmacovigilance Surveillance and Methods Used for Drug Safety Monitoring

Lecture 2: Spontaneous Reporting

Lecture 3: WHO Criteria for Spontaneous Reporting

Lecture 4: Cohort Event Monitoring (Part 1)

Lecture 5: Cohort Event Monitoring (Part 2)

Lecture 6: Difference between Cohort Event Monitoring and Spontaneous Reporting

Lecture 7: Drug Safety Monitoring – Developing a Consumer Reporting System

Lecture 8: Drug Safety Monitoring: Components of a Report And the Method of Reporting

Chapter 5: Risk Management

Lecture 1: Risk Factors

Lecture 2: Premarket Benefit-Risk Assessment

Lecture 3: Postmarket Benefit-Risk Assessment

Instructors

Magine Solutions Team
This is Our World!

Rating Distribution

1 stars: 1 votes
2 stars: 0 votes
3 stars: 7 votes
4 stars: 23 votes
5 stars: 62 votes

Frequently Asked Questions

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