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About

Our Good Pharmacovigilance Practice (GPV) online training platform allows you to access our courses from wherever you are. Get trained and certified at your convenience. If you are involved in any aspect of pharmacovigilance (GPV), our four course modules will help you comply with European & US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory and quality compliance. If you are involved in any aspect of pharmacovigilance then the Overview of Pharmacovigilance & Drug Safety course will help you comply with European & US law which states that you must have a good understanding of the principles and guidelines within pharmacovigilance. The course is perfect for you if you are involved in all areas of drug safety, pharmacovigilance, and regulatory and quality compliance. The course contains interactive mini-exams at the end of each chapter to help reinforce learning.

The Overview of Pharmacovigilance & Drug Safety course gives you a good understanding of the basic principles of pharmacovigilance – the course covers the history of pharmacovigilance & drug safety, key components within adverse event reporting in the clinical and post-marketing settings and an overview of signal detection & risk management. Keeping products on the market without interruption becomes more essential with the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance are keys to product longevity, consumer confidence and regulatory compliance. This module will provide you with a strong foundation of knowledge on pharmacovigilance and drug safety.

Course Syllabus

  1. Learning Objectives for This Module
  2. What Is Pharmacovigilance?

  1. Thalidomide 1957–1961
  2. Thalidomide’s Impact on Regulations
  3. History of Pharmacovigilance, 1962–2000
  4. History of Pharmacovigilance, 2000–Present Day

  1. Pre-Marketed AEs
  2. Limitations of Pre-Approval Clinical Trials
  3. Likelihood of Observing ADRs in Patients Usually Studied in Clinical Trials
  4. Post-Marketed AEs
  5. Pre- and Post-Marketing: Basic Differences
  6. The Importance of Adverse Event Reporting
  7. Reasons for Adverse Event Collection & Reporting

  1. Pharmacovigilance Definitions
  2. Acronyms Used in This Training Session
  3. ICH Definition of Adverse Event
  4. Examples of Adverse Events
  5. Examples of Adverse Events II
  6. ICH Definition of Adverse Drug Reaction – Clinical
  7. ICH Definition of Adverse Drug Reaction – Post-Marketing
  8. Suspected Unexpected Serious Adverse Reaction
  9. Sources of ADRs

  1. Pharmacovigilance Process

  1. Assessing Adverse Events
  2. Regulatory Definition of a Serious Adverse Event
  3. Seriousness: Life-Threatening
  4. Examples of Life-Threatening Adverse Events I
  5. Examples of Life-Threatening Adverse Events II
  6. Seriousness: Disability
  7. Seriousness: Medically Significant Events I
  8. Seriousness: Medically Significant Events II
  9. Intensity
  10. Intensity II
  11. Difficulty Assessing Relationship of AEs With Drug
  12. Causality
  13. Causality II
  14. Definitely Related
  15. Probably Related
  16. Possibly Related
  17. Unlikely to Be Related
  18. Relationship Testing
  19. Lack of Efficacy – ICH I
  20. Lack of Efficacy – ICH II
  21. Special Situations I
  22. Special Situations II – Death
  23. Special Situations III – Medical Error
  24. Expectedness
  25. Labeled vs. Listed

  1. General Types of Reports
  2. Expedited Reporting – What to Report I
  3. Expedited Reporting – What to Report II
  4. Expedited Reporting – What Not to Report
  5. Reporting Timeframes for ICSRs
  6. Reporting Timeframes for ICSRs (Continued)
  7. Reporting to IRB/ECs
  8. Investigator Notification
  9. Minimum Criteria for Reporting
  10. Minimum Data Set Day 0
  11. Reporting Format I
  12. Reporting Format II
  13. CIOMS Report
  14. FDA 3500A Report (“MedWatch” Report)
  15. Key Data Elements for Inclusion in Expedited Reports
  16. Aggregate Reports
  17. PSUR Reporting
  18. PSUR/PBRER
  19. PSUR Periodicity, Non-EU
  20. PSUR Periodicity, EU
  21. Managing Blinded Therapy Cases
  22. Managing Blinded Therapy Cases II
  23. Managing Blinded Therapy Cases III
  24. Adverse Reaction Types

Course Benefits

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CPD Points

Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.

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Certification

Receive a personal certificate to show your subject knowledge on course completion.

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Affordable

You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.

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Flexibility

The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.

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Keep Up to Date

You will stay up to date with any legislative changes in pharmacovigilance as our training courses are constantly monitored, reviewed and updated.

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Learn from Industry Experts

The course content has been developed to ensure that you comply with pharmacovigilance legislation through the application of learning outcomes. The course is written by Steve Jolley, who is a chairperson for the Drug Information Association (DIA)


Our Certified Customers

novartis
NHS
takeda
roche
dhl

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