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About
An introduction to pharmacovigilance case handling and post-market safety surveillance. Covers the ICSR lifecycle including case receipt, validation, triage, coding, and submission. Highlights global regulatory requirements (ICH, EMA, FDA, MHRA) and key concepts like seriousness, expectedness, and causality.
This course explains end-to-end case handling from data collection and Day 0 to regulatory submission. Includes validation criteria, triage processes, MedDRA coding, and follow-up procedures. Also covers quality management, common errors, special cases, and basics of signal detection and compliance.
Course Syllabus
- What is Pharmacovigilance?
- Historical Context: Thalidomide and the Birth of Modern PV
- Why is Pharmacovigilance Necessary?
- Good Pharmacovigilance Practice (GVP)
- The Pharmacovigilance System: Key Components
- End-to-End Case Handling Workflow
- Sources of Case Reports
- Receiving Data: The Initial Intake Process
- Validation of Case Reports
- Follow-Up Procedures: Getting the Missing Information
- E2B(R3): Key Data Elements in an ICSR
- Pregnancy & Breastfeeding Cases
- Paediatric Population
- Misuse, Abuse, and Overdose
- Off-Label Use & Elderly Patients
- Triage: Prioritising Cases for Processing
- Seriousness Criteria: Definitions & Examples
- Expectedness Assessment
- Causality Assessment Methods
- Duplicate Search & Complete Data Entry
- MedDRA Coding in Practice
- Quality Management in PV Case Handling
- Common Errors in PV Case Handling — and How to Prevent Them
- Writing High-Quality Case Narratives
- Follow-Up Management & Case Amendments
- Pharmacovigilance Inspections: What to Expect
- Submission of Safety Reports
- Submission Timeframes at a Glance
- EudraVigilance & the ICSR Submission Process
- Signal Detection & Management
- Risk Management Plans (RMPs)
- Market Withdrawal: The Final Protective Measure
Course Benefits
This course describes the compliance requirements for the reporting of adverse events relating to medical devices. Learners also receive 4 Continual 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.
All learners who pass the final exam receive a uniquely numbered, personal certificate to demonstrate their subject knowledge. Since the questions are picked randomly from a database, re-sitting the exam doesn’t mean taking the same questions again and again.
Our cost-effective prices represent excellent value. You can easily pay up to ten-times more for face-to-face training. We can also offer generous group discounts on larger purchases.
Our new administration system makes it incredibly quick and simple to allocate licences to multiple learners. Learners save time too by choosing when and where they complete the training. Our reporting tools make it easy for administrators to check the progress of learners and identify areas for future training.
This course was written by Steve Jolley, a recognised expert in International drug and device vigilance. You will stay up to date with any international legislative changes in device vigilance as our training courses are constantly monitored, reviewed and updated (last updated in May 2018). Steve Jolley is a Cambridge University graduate with 25 years’ experience in drug & device safety & vigilance, who specializes in global safety compliance, business process improvement and signal detection. He is the Chairperson of the DIA Clinical Safety and Pharmacovigilance steering committee for North America and has worked with over 80 clients in the US, Europe and Japan. He is a featured speaker with the FDA and MHRA at DIA conferences and webinars on drug safety topics including auditing and signaling.)


