Pharmacovigilance 2 - Global Regulatory Requirements

Module 2 of 4 - Global Regulatory Requirements Course. Updated Jan 2022

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 reinforce learning.

Average study time:

3 hrs
Personal development points (CPD):

3 points
Price:

£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.

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 Health Canada's Good Pharmacovigilance Practices I
4.10 Health Canada's Good Pharmacovigilance Practices II
4.11 Health Canada's Good Pharmacovigilance Practices III
4.12 Health Canada's Good Pharmacovigilance Practices IV
4.13 Key EU Components
4.14 EU Member States
4.15 What is Europe?
4.16 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 Regulation (& Directive)

6.1 Clinical Trials Regulation (536/2014)
6.2 Clinical Trials Information System (CTIS)
6.3 EU Clinical Trials Directive 2001/20/EC
6.4 Terminology introduced in 2001/20/EC
6.5 Key Points of 2001/20/EC
6.6 QPPV
6.7 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 Biological products
11.5 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

14. UK Requirements

14.1 UK Pharmacovigilance Requirements
14.2 UK QPPV

14.3 Feedback Form