Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

Pharmacovigilance 3 - Pv Audit

Module 3 of 4 - Pharmacovigilance Audit Course

If you need to ensure that your company is prepared for an inspection by a regulatory body, then The Pharmacovigilance Audit course will help you comply with the principles and guidelines they have set within their legislative requirements. This course will help you conduct a diagnostic overview of pharmacovigilance activities to gain a rapid understanding of the company’s current position, against the best means of practice that correspond with regulations.

  • Average study time:
    study time

    3 hrs

  • Personal development points (CPD):

    3 points

  • Price:


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Course Details

The Pharmacovigilance Audit course is perfect for you if are involved in all areas of drug safety, pharmacovigilance, regulatory and quality compliance. The course covers the key components of audits and inspections; including why they are conducted, different types of approaches to audits and how to prepare for inspections.

This course delivers an introduction to the basics of pharmacovigilance & drug safety, including in-depth explanations of audits & inspections, as well as an explanation of how to prepare for a pharmacovigilance inspection. 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 of pharmacovigilance auditing.

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. The Pharmacovigilance Audit 

2. Audits & Inspections

Audits vs Inspections
Types of Audits & Inspections
Who Can be Audited?

3. Preparing for a  Pharmacovigilance Inspection

Preparing for a Pharmacovigilance Inspection
Overview of the Pharmacovigilance Audit 
Achieving Best Practices through the Pharmacovigilance Audit
Value Derived
Pharmacovigilance Process Model

4. Audit Items

Audit Items - Collection
Audit Items - Assessment
Audit Items - Reporting
Audit Items - Analysis
Additional Audit Items

5. Company Sources of Information to be Examined

6. Pharmacovigilance Checklist 

Risk Profile


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