Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

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. Updated December 2017.

  • Average study time:
    study time

    4 hrs

  • Personal development points (CPD):

    4 points

  • Price:


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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

2. Brief History of Pharmacovigilance

Thalidomide 1957-1961
Thalidomide’s Impact on Regulations
History of Pharmacovigilance

3. Clinical vs. Post-Marketing - Adverse Events

Pre-Marketed AEs
Limitations of Pre-approval Clinical Trials
Likelihood of Observing ADRs in Patients Usually Studied in Clinical Trials
Post-Marketed AEs
Pre- and Post- marketing: Basic Differences
The Importance of Adverse Event Reporting
Reasons for Adverse Event Collection & Reporting

4. Terms, Definitions and Examples for Adverse Event Reporting

Pharmacovigilance Definitions
Common Acronyms
ICH Definition of Adverse Event
Examples of Adverse Events
ICH Definition of Adverse Drug Reaction - CLINICAL
ICH Definition of Adverse Drug Reaction - POST MARKETING
Suspected Unexpected Serious Adverse Reaction
Sources of ADRs

5. Adverse Event Process Flow

6. Assessing Adverse Event Reports

Assessing Adverse Events
Regulatory Definition of a Serious Adverse Event
Seriousness: Life Threatening
Examples of Life Threatening Adverse Events
Seriousness: Disability
Seriousness: Medically Significant Events
Serious vs. Severe Quiz 1 to 3
Difficulty Assessing Relationship of AEs with Drug
Definitely Related
Probably Related
Possibly Related 
Unlikely to be Related 
Causality Quiz 1 to 3
Relationship Testing
Lack of Efficacy - ICH
Assessing Expectedness/Labeledness/Listedness
Labelled vs. Listed

7. Reporting Adverse Events: Types, Timelines, Receivers

General Types of Reports
Expedited Reporting – What to Report
Suspected Unexpected Serious Adverse Reaction
Expedited Reporting – What not to report
Reporting Timeframes for ICSRs
Reporting to IRB/ECs
Investigator Notification
Minimum Criteria for Reporting
Minimum Data Set – Day “0”
Reporting Format
CIOMS Report
FDA 3500A Report (“MedWatch” report)
Key Data Elements for Inclusion in Expedited Reports
Aggregate Reports
PSUR Reporting
PSUR Periodicity, non-EU
PSUR Periodicity, EU
Managing Blinded Therapy Cases
Adverse Reaction Types


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