Presented by
Management Forum
Signal Detection: A Comprehensive Introduction Training Course
A comprehensive introductory guide to signal detection in pharmacovigilance, covering its history, regulations, processes, and safety assessments.
22 September 2025
+ 15 January 2026, 13 May 2026 »
from £649
- Format: Live online
- CPD: 6 hours for your records
- Certificate of completion
Course overview
This comprehensive one-day course provides an in-depth introduction to signal detection in pharmacovigilance. Participants will explore the history, regulatory requirements, and practical processes involved in detecting, validating, and acting upon safety signals. Through expert-led discussions and real-world case studies, attendees will gain a foundational understanding of how signal detection supports patient safety and regulatory compliance.
This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.
Benefits of attending
- Understand the fundamentals of signal detection in pharmacovigilance
- Learn global regulatory requirements for signal detection across drug development stages
- Explore key safety analyses, validation, and risk assessment processes
- Discuss safety review cycles, urgent signals, and labelling updates
- Hear how to assess benefit-risk and respond to safety concerns effectively
- Participate in discussions to apply learning to real-world scenarios
Who should attend?
Professionals working within these industries, who want a comprehensive introduction, will benefit from this engaging course:
- Clinical
- Pharmacovigilance
- Regulatory
This course will cover:
The history of signal detection
- Signals through the ages
- The introduction of regulations for signal detection
- What is a signal – regulatory definitions
- When does signal detection begin?
Regulatory requirements for signal detection
- Signal detection in pre-clinical studies
- Signal detection in clinical trails
- Signal detection and licence submission – Risk Management Plans (RMPs)
Regulatory expectations (post-marketing for signal detection)
- The safety review cycle – innovator products
- The safety review cycle – generic products
- Frequency for signal detection
- Risks and signal detection
Signal detection process
- The safety review cycle
- Safety analyses – what to include?
- Safety signal validation
- Pending signals vs. closed signals
From signal to labelling
- Signal verification and labelling updates
- The Pharmacovigilance Risk Assessment Committee EU (PRAC) and safety updates
- Urgent safety signals and reporting
- Benefit-risk determinations
- Removing a product from the market due to safety reasons
Graeme Ladds
PharSafer Associates Ltd
Graeme is Director of PharSafer and has over 30 years’ experience working in the pharmaceutical industry, having started his career at Ashbourne Pharmaceuticals as Head of Drug Safety and Medical Information. Graham has a wealth of experience establishing pharmacovigilance within companies.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
22 September 2025
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15684
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 18 Aug
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
15 January 2026
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15685
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 11 Dec
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
13 May 2026
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15686
- GBP 649 749
- EUR 909 1,049
- USD 1,043 1,199
Until 08 Apr
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Run Signal Detection: A Comprehensive Introduction Live online for your team
Pricing from:
- GBP 500
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
