Pharmacovigilance Training Online
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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. 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

    3 hrs

  • Personal development points (CPD):
    points

    3 points

  • Price:
    points

    £79.00

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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

  • 1.1 Learning Objectives 

2. US Legislature 

  • 2.1 US Law 
  • 2.2 US Regulations 
  • 2.3 US Guidances 
  • 2.4 US Penalties for Non-Compliance 
  • 2.5 US Penalties for Non-Compliance II 
  • 2.6 Mini exam

3. EU Legislature 

  • 3.1 EU Legalities 
  • 3.2 EU Regulations 
  • 3.3 EU Directives 
  • 3.4 Why worry about EU PV laws? 
  • 3.5 Non-compliance subject to penalties in the EU 
  • 3.6 MHRA Infringement Notice
  • 3.7 Mini exam 

4. Matrix of Safety Regulations 

  • 4.1 Matrix of Safety Regulations 
  • 4.2 US Post-marketing Safety Reporting 
  • 4.3 FDA Regulation for IND safety reporting 
  • 4.4 IND Annual Report 
  • 4.5 Literature Reporting 
  • 4.6 International Conference on Harmonisation 
  • 4.7 ICH Topic Codes 
  • 4.8 Council of International Organizations of Medical Sciences (CIOMS) 
  • 4.9 Key EU Components 
  • 4.10 EU Member States 
  • 4.11 What is Europe? 
  • 4.12 Mini exam

5. EudraVigilance 

  • 5.1 Introduction 
  • 5.2 EudraVigilance – Pre-Marketing Requirements 
  • 5.3 EudraVigilance – Post-Marketing Requirements 
  • 5.4 EUDRA CT Database
  • 5.5 Mini exam 

6. The EU Clinical Trials Directive 

  • 6.1 EU Clinical Trial Guidance 2001/20/EC 
  • 6.2 Directive 2001/20/EC 
  • 6.3 Contents of EU Clinical Trials Directive 
  • 6.4 Supporting Guidance Documents 
  • 6.5 Intentions of Directive 2001/20/EC 
  • 6.6 Terminology in 2001/20/EC 
  • 6.7 Key Points 
  • 6.8 Key Points II 
  • 6.9 Volume 10 
  • 6.10 QPPV 
  • 6.11 Mini exam

7. The Development Safety Update report (DSUR) 

  • 7.1 The Development Safety Update report (DSUR) 
  • 7.2 DSUR Format & Contents 
  • 7.3 Mini exam

8. Other European Regulations 

  • 8.1 Signalling 
  • 8.2 Good Pharmacovigilance Practice (GVP) & European Pharmacovigilance Legislation 
  • 8.3 European Pharmacovigilance Legislation - Quick Summary of Changes 
  • 8.4 Why the new EU PV laws were introduced 
  • 8.5 Pharmacovigilance Fees 
  • 8.6 GVP Modules 
  • 8.7 Mini exam

9. GVP Module I - Quality System 

  • 9.1 Requirements for Quality Systems 
  • 9.2 Audits 
  • 9.3 Inspections 
  • 9.4 Mini exam

10. GVP Module II - PV System Master File 

  • 10.1 Pharmacovigilance Systems Information 
  • 10.2 Content 
  • 10.3 Mini exam

11. GVP Module VI - ADR reporting 

  • 11.1 ADR Reporting 
  • 11.2 The Internet 
  • 11.3 Post-authorisation Studies 
  • 11.4 ICSR format
  • 11.5 Biological products 
  • 11.6 Mini exams

12. GVP Module VII - Periodic Safety Update Report 

  • 12.1 PSUR/PBRER 
  • 12.2 PSUR Periodicity, ex-EU 
  • 12.3 PSUR Periodicity, EU 
  • 12.4 PSUR new features 
  • 12.5 PSUR Sections - Product status and patient exposure 
  • 12.6 PSUR Sections - Cumulative and Interval information 
  • 12.7 PSUR Sections - Analysis and Recommendations 
  • 12.8 Mini exam

13. GVP Module IX - Signal Management 

  • 13.1 Steps in the signal management process 
  • 13.2 Signal validation considerations 
  • 13.3 Signal Management - MAH responsibilities 
  • 13.4 EudraVigilance Monitoring 
  • 13.5 EudraVigilance Monitoring II
  • 13.6 Mini exam

 

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