New
SM
Clara Fargo
EBMT Clinical Research Quality Assurance Coordinator
I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
Introduction to Good Pharmacovigilance Practice (GVP) Course & Certification
Intermediate
Watch Preview
4.7
★★★★★
97% Recommended
3 hours
0 active users
2 points
Watch Preview
Your Study Basket
Introduction to Good Pharmacovigilance Practice (GVP)
| Total |
VAT is levied as per your country’s applicable rules and rates at checkout
Save more with a monthly or annual plan that includes this course
Secure Payment Service
Rest assured we use secure processes to protect your payment.
Secured by:
About
The Introduction to Good Pharmacovigilance Practice (GVP) Course & Certification is designed to provide a foundational understanding of pharmacovigilance principles and regulatory guidelines for ensuring drug safety. The course focuses on how adverse events are identified, assessed, reported, and monitored throughout the product lifecycle.
This course covers GVP modules, pharmacovigilance system requirements, adverse event reporting, signal detection basics, risk management principles, safety data handling, and regulatory expectations. It also emphasizes compliance with global drug safety standards, documentation practices, and inspection readiness. Upon successful completion, learners receive a certification demonstrating competency in Good Pharmacovigilance Practice fundamentals.
Who Should Enrol ?:
- Pharmacovigilance Professionals
- Drug Safety and Risk Management Teams
- Clinical Research Professionals
- Regulatory Affairs Professionals
- Medical Writing and Literature Surveillance Teams
- Quality Assurance and Compliance Professionals
- Pharmaceutical and Biotechnology Employees
- Life Science, Pharmacy, Nursing, and Medical Graduates
What you will learn
Understand the fundamentals of pharmacovigilance, including its purpose, scope, and role in ensuring patient safety and drug effectiveness.
Learn key global pharmacovigilance regulations, terminology, and the overall lifecycle of safety monitoring activities.
Gain knowledge of core PV processes such as individual case safety reports (ICSRs), signal detection, risk management, and pharmacovigilance planning.
Develop an understanding of modern PV practices, including the use of technology and AI, along with career pathways in the pharmacovigilance field.
Course Syllabus
- What pharmacovigilance is
- How PV evolved
- The PV mission today
- Who does PV
- Pharmacovigilance and the wider system
- Why we need rules
- EMA GVP - the EU rule book
- MHRA, FDA and the rest of the world
- ICH and global harmonisation
- EudraVigilance and inspections
- AE, ADR and the family
- Expectedness, SUSAR and reporting
- Causality — who decides, and how
- Signals and risk-benefit
- The medicine lifecycle
- Approval and the handover
- Spontaneous reporting
- Literature and aggregate reporting
- Lifecycle thinking in practice
- What an ICSR is
- Inside a case
- Seriousness, expectedness, causality — applied
- Who reports — and by when
- How ICSRs fit the bigger picture
- What signal are
- How signals are detected
- Signal management lifecycle
- Risk minimisation and RMPs
- People and roles in signal management
- How to develop a Pharmacovigilance Plan
- Pharmacoepidemiologic assessment
- Contents of a Pharmacovigilance Plan
- Why technology matters in PV
- The tools you'll meet
- AI in pharmacovigilance
- Doing AI well in PV
- Human oversight — why it stays
- PV roles at a glance
- Where to start
- skills that build PV careers
- Specialist or generalist
- The Whitehall advanced PV programmes
Course Benefits
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 changes to EMA GVP Modules, MHRA Pharmacovigilance guidance, FDA post-marketing requirements, ICH E2 safety guidelines and EudraVigilance reporting standards as this course is continuously monitored, reviewed and refreshed.
Learn from Industry Experts
The course content has been developed by Whitehall pharmacovigilance faculty drawing on EU, UK and US regulator practice and CIOMS conventions, so that learners build confident, inspection-ready foundations they can apply on the job from day one.
Our Certified Customers
Learner Rating & Reviews
4.7
★★★★★★
Average Rating
536 global ratings
★★★★★
87.0%
★★★★★
5.0%
★★★★★
3.0%
★★★★★
3.0%
★★★★★
2.0%
