Pharmaceutical Industry Pharmacovigilance & Drug Safety

سرفصل های دوره

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

1. Introduction to Pharmacovigilance and Drug Safety

1. Introduction

2. Partners in Pharmacovigilance and Drug Safety Monitoring

3. National Pharmacovigilance Centers Role in ADRs Reporting

2. Good Pharmacovigilance Practices

1. Introduction and Principles

2. Pharmacovigilance Quality Management Systems

3. Significances and impacts of Pharmacovigilance Quality Management Systems

4. Pharmacovigilance System Master File and Pharmacovigilance Inspections

5. Pharmacovigilance Audit and Risk Management

6. Collection, Management and Submission of Report

7. Periodic Safety Update Report

8. Post-Authorization Safety Study

9. Signal Management and Additional Monitoring

10. Safety Communication

11. Risk Minimization Measures

3. Signals

1. Signals and Signals Identification

2. Methods of Signals Identification

3. Strengthening the Signal

4. Pharmacovigilance Indicators

5. Relationships and Causality Assessment

6. WHO-UMC Causality Assessment System

7. Algorithmic Methods for Causality Assessment

4. Pharmacovigilance Surveillance and Methods

1. Pharmacovigilance Surveillance and Methods Used for Drug Safety Monitoring

2. Spontaneous Reporting

3. WHO Criteria for Spontaneous Reporting

4. Cohort Event Monitoring (Part 1)

5. Cohort Event Monitoring (Part 2)

6. Difference between Cohort Event Monitoring and Spontaneous Reporting

7. Drug Safety Monitoring - Developing a Consumer Reporting System

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

5. Risk Management

1. Risk Factors

2. Premarket Benefit-Risk Assessment

3. Postmarket Benefit-Risk Assessment

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تولید کننده: Udemy