Pharmacovigilance Training Online
Choose from 4 GPvP Online Courses

Pharmacovigilance 2 - Global Regulatory Requirements

Module 2 of 4 - Global Regulatory Requirements Course

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 & Drug Safety course. Updated December 2017.

  • Average study time:
    study time

    3 hrs

  • Personal development points (CPD):

    3 points

  • Price:


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Course Details

The Pharmacovigilance Global Regulatory Requirements course covers the key components of US and EU legislation, US and EU 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 delivers an explanation to the global regulatory requirements of pharmacovigilance and thoroughly explains the regulatory issues across global government agencies that improve safety across international markets. 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 the global legislation attributed with 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. Learning Objectives for this Module

2. US Legislature 

US Law
US Regulations
US Guidances
US Penalties for Non-Compliance

3. EU Legislature

EU Legalities
EU Regulations
EU Directives

4. Matrix of Safety Regulations

Safety Regulations
Post-marketing Safety Reporting
New FDA Regulation for IND safety reporting
IND Annual Report
Literature Reporting
International Conference on Harmonisation 
ICH Topic Codes and Reports
ICH Topic Codes
Council of International Organizations of Medical Sciences (CIOMS)
Key EU Components
EU Member States
What is Europe?

5. EudraVigilance 

EudraVigilance – Pre-Marketing Requirements    
EudraVigilance – Post-Marketing Requirements    
EUDRA CT Database

6. The EU Clinical Trials Directive

EU Clinical Trial Guidance 2001/20/EC
Directive 2001/20/EC
Contents of EU Clinical Trials Directive
Supporting Guidance Documents
Intentions of Directive 2001/20/EC
Terminology in 2001/20/EC
Key Points
Volume 10
Volume 9A
Basics of Volume 9a

7. The Development Safety Update report (DSUR)

The Development Safety Update report (DSUR)
DSUR Format & Contents

8. Other European Regulations

New European Pharmacovigilance Legislation
Why the new EU PV laws were introduced
Pharmacovigilance Fees
GVP Modules released to date (July 2013)
GVP Modules yet to be published (as of July 2013)
The future of Volume 9A
New European Pharmacovigilance Legislation - summary when first introduced
Module I (New requirements for quality systems)
Module I - Audits
Module I - Inspections
Module II (Pv system master file)
Module II - Timetable
Module II - How to introduce a PSMF
Module II - Content of the PSMF
Module VI (ADR reporting)
Module VI - Reporting during transition
Module VI - Final reporting arrangements
Module VII (Periodic Safety Update Report)
Module VII - Non-EU periodicity
Module VII - EU periodicity
Module VII - PSUR new features
Module VII - PSUR Sections
Module IX (Signal management)
Module IX - Signal validation considerations
Module IX - Types of action to be considered by a CA
Module IX - EMA responsibilities
Module IX - MAH responsibilities
Module X (Additional monitoring)
Why worry about the new EU PV laws?
Non-compliance subject to penalties in the EU


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