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Pharmacovigilance: Signalling and Risk Assessment (English) Course & Certification
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Pharmacovigilance: Signalling and Risk Assessment (English)
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About
Pharmacovigilance: Signalling and Risk Assessment focuses on the identification, evaluation, and management of safety signals to ensure the ongoing benefit–risk balance of medicinal products. It explains how potential safety issues are detected from clinical and post-marketing data and assessed for regulatory action.
This Pharmacovigilance: Signalling and Risk Assessment (English) Course & Certification provides a practical and structured understanding of signal detection methodologies, regulatory frameworks, and risk evaluation techniques. The course covers the background and importance of signal detection, global legal requirements, data analysis approaches, statistical and data mining methods, and real-world regulatory case examples. Upon completion, learners receive a certification demonstrating their ability to contribute to effective signal management and drug safety decision-making.
Who Should Enrol ?:
- Pharmacovigilance and Drug Safety Professionals
- Signal Detection and Safety Data Analysts
- Regulatory Affairs Professionals
- Clinical Research and Medical Affairs Teams
- Biostatistics and Data Management Professionals
- Quality Assurance and Compliance Personnel
- QPPVs and Pharmacovigilance Managers
- Pharmaceutical and Biotechnology Industry Employees
- Life Science, Pharmacy, and Medical Graduates
- Anyone involved in drug safety evaluation and risk management
What you will learn
Understand the fundamentals of pharmacovigilance signal detection, signal management processes, and the importance of monitoring drug safety risks.
Learn global regulatory requirements related to signal detection, including FDA, MHRA, EudraVigilance, and GVP Module IX guidelines.
Develop knowledge of signal detection objectives, adverse event analysis methods, data visualization, and safety trend evaluation techniques.
Gain understanding of data mining methods, statistical signal detection approaches, and pharmacovigilance reporting practices used to identify potential drug safety concerns.
Course Syllabus
- Learning Objectives for This Module
- What Is Pharmacovigilance?
- What Is a Signal?
- Need for Signal Detection
- Increased Withdrawals (1998–2001)
- Reason for Change
- Rezulin Withdrawal
- Baycol Withdrawal
- The Cost of Failure
- FDA Risk Management Components
- FDA Amendment Act (FDAAA)
- European Signalling Requirements
- GVP Module IX – Signal Management
- MHRA & Signal Detection
- EudraVigilance Monitoring
- Signal Detection Objectives
- AE Incidence Rate
- Numerator (AEs)
- Denominator (Patient Exposure)
- Rates
- Premise
- Need for the Prepared Mind
- CIOMS VIII Report
- Signal Detection Hierarchy
- Signalling Analyses
- Approach to Signal Detection – Small Companies
- Approach to Signal Detection – Large Companies
- Data Extraction and Visualization
- Data Flow
- PSUR Prior to Analysis
- Sector Map by SOC
- Sector Map by PT
- Analysis by Cause of Death
- Analysis by Preferred Term I
- Analysis by Preferred Term II
- Analysis by Preferred Term III
- Analysis by Age Range
- Analysis by Sex
- Analysis by Country
- Analysis by Time to Onset
- Analysis by Treatment Duration
- Analysis by AE Duration
- Analysis by Concomitant Medications
- Analysis by Concomitant Medications II
- Hypotheses
- What Is Data Mining?
- Principles of Safety Data Mining
- Data Mining Challenge
- Recommended Approach – Large Companies
- Data Mining Methods
- Information Component (IC)
- Bayesian Confidence Propagation Neural Network (BCPNN)
- PSUR Data
- IC Scores: PSUR
- Increased frequency analysis of PTs from company PSUR
- Comparison of increased frequency of company reports to IC scores in FDA AERS
- SDRs to be investigated
- Multi-item Gamma Poisson Shrinker (MGPS)
- Proportional Reporting Ratio (PRR)
- PRR example
- Final conclusion
- 📘 Bonus: Pharmacovigilance Signalling and Risk Assessment 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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