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About

Our Good Pharmacovigilance Practice (GPV) online training platform allows you to access our courses from anywhere. 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 and US law. The modules are perfect for you if you are involved in drug safety, pharmacovigilance, regulatory, and quality compliance. If you would like to strengthen your pharmacovigilance knowledge, then this course will help you comply with global regulatory requirements, which state that you must have a good understanding of the principles and guidelines within pharmacovigilance. The Pharmacovigilance Global Regulatory Requirements course is perfect for you if you are involved in all areas of drug safety, pharmacovigilance, regulatory, and quality compliance, and is a great addition to your knowledge in pharmacovigilance when combined with the Overview of Pharmacovigilance and Drug Safety course. The course contains interactive mini-exams at the end of each chapter to help reinforce learning.

The Pharmacovigilance Global Regulatory Requirements course covers the key components of US and EU legislation and safety reporting regulations, including publications by the Council for International Organizations of Medical Sciences (CIOMS) and guidelines from the International Conference on Harmonisation (ICH). The course explains the global regulatory requirements of pharmacovigilance and thoroughly addresses regulatory issues across international government agencies that enhance safety in global markets. Keeping products on the market without interruption becomes increasingly essential due to the reduced pipeline of drugs in development. Successful navigation of drug safety and pharmacovigilance is key to product longevity, consumer confidence, and regulatory compliance. This module will provide you with a strong foundation of knowledge regarding the global legislation governing pharmacovigilance and drug safety.

Course Syllabus

  1. Learning Objectives

  1. US Law
  2. US Regulations
  3. US Guidance
  4. US Penalties for Non-Compliance I
  5. US Penalties for Non-Compliance II

  1. EU Legalities
  2. EU Regulations
  3. EU Directives
  4. Why Worry About EU PV Laws?
  5. Non-Compliance Subject to Penalties in the EU
  6. MHRA Infringement Notice

  1. Matrix of Safety Regulations
  2. US Post-Marketing Safety Reporting
  3. FDA Regulation for IND Safety Reporting
  4. IND Annual Report
  5. Literature Reporting
  6. International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
  7. International Conference on Harmonisation
  8. ICH Topic Codes I
  9. ICH Topic Codes II
  10. ICH Topic Codes III
  11. Council of International Organizations of Medical Sciences (CIOMS)
  12. Health Canada's Good Pharmacovigilance Practices I
  13. Health Canada's Good Pharmacovigilance Practices II
  14. Health Canada's Good Pharmacovigilance Practices III
  15. Health Canada's Good Pharmacovigilance Practices IV
  16. Health Canada's Good Pharmacovigilance Practices V
  17. Health Canada's Good Pharmacovigilance Practices VI
  18. Health Canada's Good Pharmacovigilance Practices VII
  19. Key EU Components
  20. EU Member States
  21. What Is Europe?

  1. Introduction
  2. EudraVigilance – Pre-Marketing Requirements
  3. EudraVigilance – Post-Marketing Requirements
  4. EudraCT Database

  1. Clinical Trials Regulation (536/2014)
  2. Clinical Trials Information System (CTIS)
  3. EU Clinical Trials Directive 2001/20/EC
  4. Terminology Introduced in 2001/20/EC
  5. Key Points of 2001/20/EC I
  6. Key Points of 2001/20/EC II
  7. QPPV
  8. QPPV Responsibilities
  9. QPPV: Responsibility of the PV System

  1. The Development Safety Update Report (DSUR)
  2. DSUR Format and Contents

  1. Signalling
  2. Good Pharmacovigilance Practice (GVP) and European Pharmacovigilance Legislation
  3. European Pharmacovigilance Legislation – Quick Summary of Changes
  4. Why the New EU PV Laws Were Introduced
  5. Pharmacovigilance Fees
  6. GVP Modules
  7. Further Details

  1. Requirements for Quality Systems
  2. Audits
  3. Inspections

  1. Pharmacovigilance System Master File
  2. Content

  1. ADR Reporting
  2. The Internet
  3. Post-Authorisation Studies
  4. Biological Products

  1. PSUR/PBRER
  2. PSUR Periodicity, Ex-EU
  3. PSUR Periodicity, EU
  4. PSUR (PBRER) New Features
  5. PSUR Sections – Product Status and Patient Exposure
  6. PSUR Sections – Cumulative and Interval Information
  7. PSUR Sections – Analysis and Recommendations

  1. Steps in the Signal Management Process
  2. Signal Validation Considerations
  3. Signal Management – MAH Responsibilities
  4. Signal Management – MAH Responsibilities
  5. EudraVigilance Monitoring I
  6. EudraVigilance Monitoring II
  7. EudraVigilance Monitoring III

  1. UK Pharmacovigilance Requirements
  2. UK Pharmacovigilance Requirement

Course Benefits

Benefits cpd_points icon
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)


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