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Global Regulatory Requirements Course & Certification
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About
Pharmacovigilance Global Regulatory Requirements provides a comprehensive understanding of international drug safety laws, guidelines, and regulatory frameworks across key regions including the US, EU, and UK. It explains how pharmacovigilance systems are structured globally to ensure patient safety, regulatory compliance, and effective risk management of medicinal products.
This Pharmacovigilance Global Regulatory Requirements Course & Certification covers major regulatory authorities, legislation, reporting systems, and global safety standards such as FDA requirements, EU pharmacovigilance legislation, EudraVigilance, ICH guidelines, GVP modules, DSUR reporting, signal management, and QPPV responsibilities. The course also includes UK-specific pharmacovigilance requirements and practical insights into compliance and inspection readiness. Upon completion, learners receive a certification demonstrating their knowledge of global pharmacovigilance regulatory frameworks.
Who Should Enrol ?:
- Pharmacovigilance and Drug Safety Professionals
- Regulatory Affairs Specialists
- Clinical Research Associates (CRAs) and Clinical Trial Teams
- Quality Assurance and Compliance Professionals
- Medical Affairs and Pharmacovigilance Managers
- Pharmaceutical and Biotechnology Industry Employees
- QPPVs and Deputy QPPVs
- Life Science, Pharmacy, and Medical Graduates
- Anyone involved in global drug safety and regulatory compliance
What you will learn
Understand global Pharmacovigilance regulations, including US, EU, UK, ICH, and Health Canada safety reporting requirements and compliance standards.
Learn adverse drug reaction (ADR) reporting processes, EudraVigilance requirements, DSURs, PSUR/PBRER reporting, and signal management practices.
Develop knowledge of GVP modules, quality systems, pharmacovigilance system master files, audits, inspections, and regulatory responsibilities.
Gain understanding of clinical trial safety reporting, CTIS requirements, QPPV responsibilities, and international pharmacovigilance legislation for maintaining drug safety compliance.
Course Syllabus
- Learning Objectives
- US Law
- US Regulations
- US Guidance
- US Penalties for Non-Compliance I
- US Penalties for Non-Compliance II
- EU Legalities
- EU Regulations
- EU Directives
- Why Worry About EU PV Laws?
- Non-Compliance Subject to Penalties in the EU
- MHRA Infringement Notice
- Matrix of Safety Regulations
- US Post-Marketing Safety Reporting
- FDA Regulation for IND Safety Reporting
- IND Annual Report
- Literature Reporting
- International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- International Conference on Harmonisation
- ICH Topic Codes I
- ICH Topic Codes II
- ICH Topic Codes III
- Council of International Organizations of Medical Sciences (CIOMS)
- Health Canada's Good Pharmacovigilance Practices I
- Health Canada's Good Pharmacovigilance Practices II
- Health Canada's Good Pharmacovigilance Practices III
- Health Canada's Good Pharmacovigilance Practices IV
- Health Canada's Good Pharmacovigilance Practices V
- Health Canada's Good Pharmacovigilance Practices VI
- Health Canada's Good Pharmacovigilance Practices VII
- Key EU Components
- EU Member States
- What Is Europe?
- Introduction
- EudraVigilance – Pre-Marketing Requirements
- EudraVigilance – Post-Marketing Requirements
- EudraCT Database
- Clinical Trials Regulation (536/2014)
- Clinical Trials Information System (CTIS)
- EU Clinical Trials Directive 2001/20/EC
- Terminology Introduced in 2001/20/EC
- Key Points of 2001/20/EC I
- Key Points of 2001/20/EC II
- QPPV
- QPPV Responsibilities
- QPPV: Responsibility of the PV System
- The Development Safety Update Report (DSUR)
- DSUR Format and Contents
- Signalling
- Good Pharmacovigilance Practice (GVP) and European Pharmacovigilance Legislation
- European Pharmacovigilance Legislation – Quick Summary of Changes
- Why the New EU PV Laws Were Introduced
- Pharmacovigilance Fees
- GVP Modules
- Further Details
- Requirements for Quality Systems
- Audits
- Inspections
- Pharmacovigilance System Master File
- Content
- ADR Reporting
- The Internet
- Post-Authorisation Studies
- Biological Products
- PSUR/PBRER
- PSUR Periodicity, Ex-EU
- PSUR Periodicity, EU
- PSUR (PBRER) New Features
- PSUR Sections – Product Status and Patient Exposure
- PSUR Sections – Cumulative and Interval Information
- PSUR Sections – Analysis and Recommendations
- Steps in the Signal Management Process
- Signal Validation Considerations
- Signal Management – MAH Responsibilities
- Signal Management – MAH Responsibilities
- EudraVigilance Monitoring I
- EudraVigilance Monitoring II
- EudraVigilance Monitoring III
- UK Pharmacovigilance Requirements
- UK Pharmacovigilance Requirement
- 📘 Bonus: Pharmacovigilance Global Regulatory eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
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)
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