Pharmacovigilance Training Online
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Pharmacovigilance 1 - Drug Safety

Module 1 of 4 - Overview of Pharmacovigilance & Drug Safety Course

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, regulatory and quality compliance. The course contains interactive mini exams at the end of each chapter to help re-inforce learning. Updated March 2020.

  • Average study time:
    study time

    4 hrs

  • Personal development points (CPD):
    points

    4 points

  • Price:
    points

    £79.00

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Course Details

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.

Benefits for you

  • 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.
  • Certification - Receive a personal certificate to show your subject knowledge on course completion.
  • Affordable - You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
  • Flexibility - The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
  • 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.
  • 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)

Course Syllabus

1. Overview of Pharmacovigilance 

  • 1.1 Learning Objectives for this Module 
  • 1.2 What is pharmacovigilance? 

2. Brief History of Pharmacovigilance 

  • 2.1 Thalidomide 1957-1961 
  • 2.2 Thalidomide’s Impact on Regulations 
  • 2.3 History of Pharmacovigilance - 1962-2000 
  • 2.4 History of Pharmacovigilance - 2000-2020 
  • 2.5 Mini exam

3. Clinical vs. Post-Marketing - Adverse Events 

  • 3.1 Pre-Marketed AEs 
  • 3.2 Limitations of Pre-approval Clinical Trials 
  • 3.3 Likelihood of Observing ADRs in Patients Usually Studied in Clinical Trials 
  • 3.4 Post-Marketed AEs 
  • 3.5 Pre- and Post- marketing: Basic Differences 
  • 3.6 The Importance of Adverse Event Reporting 
  • 3.7 Reasons for Adverse Event Collection & Reporting
  • 3.8 Mini exam 

4. Terms, Definitions and Examples for Adverse Event Reporting 

  • 4.1 Pharmacovigilance Definitions 
  • 4.2 Acronyms Used in this Training Session 
  • 4.3 ICH Definition of Adverse Event 
  • 4.4 Examples of Adverse Events 
  • 4.5 Examples of Adverse Events II 
  • 4.6 ICH Definition of Adverse Drug Reaction - CLINICAL 
  • 4.7 ICH Definition of Adverse Drug Reaction - POST MARKETING 
  • 4.8 Suspected Unexpected Serious Adverse Reaction 
  • 4.9 Sources of ADRs 
  • 4.10 Mini exam

5. Adverse Event Process Flow 

  • 5.1 Pharmacovigilance Process 
  • 5.2 Mini exam

6. Assessing Adverse Event Reports 

  • 6.1 Assessing Adverse Events 
  • 6.2 Regulatory Definition of a Serious Adverse Event 
  • 6.3 Seriousness: Life Threatening 
  • 6.4 Examples of Life Threatening Adverse Events 
  • 6.5 Seriousness: Disability 
  • 6.6 Seriousness: Medically Significant Events 
  • 6.7 Intensity 
  • 6.8 Intensity II 
  • 6.9 Serious vs. Severe Quiz
  • 6.10 Difficulty Assessing Relationship of AEs with Drug 
  • 6.11 Causality 
  • 6.12 Causality II 
  • 6.13 Definitely Related 
  • 6.14 Probably Related 
  • 6.15 Possibly Related 
  • 6.16 Unlikely to be Related 
  • 6.17 Causality Quiz 
  • 6.18 Relationship Testing 
  • 6.19 Lack of Efficacy - ICH 
  • 6.20 Expectedness 
  • 6.21 Assessing Expectedness/Labeledness/Listedness 
  • 6.22 Labelled vs. Listed
  • 6.23 Mini exam

7. Reporting Adverse Events: Types, Timelines, Receivers

  • 7.1 General Types of Reports 
  • 7.2 Expedited Reporting – What to Report 
  • 7.3 Expedited Reporting – What to Report II 
  • 7.4 Expedited Reporting – What not to report 
  • 7.5 Reporting Timeframes for ICSRs 
  • 7.6 Reporting Timeframes for ICSRs continued. 
  • 7.7 Reporting to IRB/ECs 
  • 7.8 Investigator Notification 
  • 7.9 Minimum Criteria for Reporting 
  • 7.10 Minimum Data Set – Day “0” 
  • 7.11 Reporting Format 
  • 7.12 Reporting Format II 
  • 7.13 CIOMS Report 
  • 7.14 FDA 3500A Report (“MedWatch” report) 
  • 7.15 Key Data Elements for Inclusion in Expedited Reports 
  • 7.16 Aggregate Reports 
  • 7.17 PSUR Reporting 
  • 7.18 PSUR/PBRER 
  • 7.19 PSUR Periodicity, non-EU 
  • 7.20 PSUR Periodicity, EU 
  • 7.21 Managing Blinded Therapy Cases 
  • 7.22 Managing Blinded Therapy Cases II 
  • 7.23 Managing Blinded Therapy Cases III 
  • 7.24 Adverse Reaction Types
  • 7.25 Mini exam

 

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