Pharmaceutical Industry Pharmacovigilance & Drug Safety

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Magine Solutions Team

2:12:46

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1. Introduction to Pharmacovigilance and Drug Safety

1. Introduction.mp4

06:18

2. Partners in Pharmacovigilance and Drug Safety Monitoring.mp4

03:30

3. National Pharmacovigilance Centers Role in ADRs Reporting.mp4

03:38

2. Good Pharmacovigilance Practices

1. Introduction and Principles.mp4

01:30

2. Pharmacovigilance Quality Management Systems.mp4

03:25

3. Significances and impacts of Pharmacovigilance Quality Management Systems.mp4

04:54

4. Pharmacovigilance System Master File and Pharmacovigilance Inspections.mp4

03:32

5. Pharmacovigilance Audit and Risk Management.mp4

06:36

6. Collection, Management and Submission of Report.mp4

04:34

7. Periodic Safety Update Report.mp4

02:09

8. Post-Authorization Safety Study.mp4

03:55

9. Signal Management and Additional Monitoring.mp4

03:13

10. Safety Communication.mp4

04:11

11. Risk Minimization Measures.mp4

06:03

3. Signals

1. Signals and Signals Identification.mp4

03:01

2. Methods of Signals Identification.mp4

03:52

3. Strengthening the Signal.mp4

04:20

4. Pharmacovigilance Indicators.mp4

07:03

5. Relationships and Causality Assessment.mp4

04:23

6. WHO-UMC Causality Assessment System.mp4

05:09

7. Algorithmic Methods for Causality Assessment.mp4

02:21

4. Pharmacovigilance Surveillance and Methods

1. Pharmacovigilance Surveillance and Methods Used for Drug Safety Monitoring.mp4

03:33

2. Spontaneous Reporting.mp4

03:43

3. WHO Criteria for Spontaneous Reporting.mp4

05:11

4. Cohort Event Monitoring (Part 1).mp4

02:26

5. Cohort Event Monitoring (Part 2).mp4

03:15

6. Difference between Cohort Event Monitoring and Spontaneous Reporting.mp4

03:22

7. Drug Safety Monitoring - Developing a Consumer Reporting System.mp4

03:51

8. Drug Safety Monitoring Components of a Report And the Method of Reporting.mp4

04:02

5. Risk Management

1. Risk Factors.mp4

05:20

2. Premarket Benefit-Risk Assessment.mp4

06:47

3. Postmarket Benefit-Risk Assessment.mp4

03:39

Description

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.

Who is this 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.

What You Need to Know?

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

More details

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.
Who this course is 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.

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