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Management Forum

Signal Detection and Regulatory Expectations Training Course

This two-day programme will give you a comprehensive review of signal detection and regulatory expectations including the new updated Signal Module IX and Eudravigilance quantitative signal requirement

1-2 July 2024
+ 12-15 November 2024 »
from £1099

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

Increasingly, the most common critical findings in regulatory inspections are being given for signal detection and signal management – so the need to identify potential signals and risks in patients has never been greater. The protection of patients through robust and clear methodologies for signal detection amidst the ever-increasing regulations requires companies to have trained and competent staff to perform such activities.

This course will provide a detailed overview of all aspects of safety reviews and signal detection within a company and will cover signal evaluation for both innovator and generic products under the updated Module IX (and addendum) signal management and the links to RMP/REMs; Benefit-Risk determinations and quantitative signal assessments.

Practical examples and exercises are performed throughout the course.

Benefits of attending:

Clarify the EU/FDA regulatory requirements for signal detection
Data sources to be used in signal detection
Learn to understand the EudraVigilance quantitative signal tool utilising the EVDAS functionalities and outputs
Understand the safety review cycle and the safety review meeting and process
Discuss safety communication – the CCSI/SCSI and labelling
Processes for urgent safety restrictions
Gain a better understanding of risk-benefit analysis – benefit-risk assessments and benefit-risk outcomes
Understand the influence of signals on RMPs/REMs and PASS
Practical examples and scenarios for delegates to consider and work on

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.

Who should attend

This course will be of interest to all those working in drug safety/pharmacovigilance as well as regulatory personnel responsible for amending the labelling for products and for the production of the CCSI/DCSI.

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The Signal Detection and Regulatory Expectations course will cover:

An introduction to safety signals

History of safety signals
The nature of safety signals
The definition of safety signals
Safety sources for signal detection

Causality and signal detection

Causality assessments for signal review
Data quality in safety assessments
Causality versus incidence (DMEs and IMEs)
Generic and innovator products

The safety review meeting and process

Setting up a safety review
Risk determinations for safety review signal trackers
Information and templates
Logistical safety and product safety
Information from safety reviews

Safety assessments life cycle

Pre-clinical safety
Clinical safety
Class-related safety issues
Post-marketing safety
Product suspensions/withdrawals

The regulatory requirements for signal detection – Module IX

The frequency of safety reviews (risk assessment)
The EU and US signal detection requirements
Signal detection and benefit-risk assessments
The regulators and signals

The signal review cycle

Safety profiling
Signal detection, validation, confirmation
Analysis and prioritisation, assessment
Recommendation for action

Quantitative and qualitative signal detections

Standard MedDRA queries (SMQs) and signal detection
ICSRs and case quality
Follow-up methodology and regulatory requirements
Events of special interest

Signals and their discussion

Signals and DSURs
Signals and PSURs/PBRERs
Signals and risk management plans/REMs and minimisation
Signals and labelling

Safety communication

The CCSI/DCSI and labelling
Triaging for safety amendments
Emerging safety issues
Urgent safety restrictions
Product suspension and withdrawal

Quantitative signal analysis

Signal detection methodologies
Background – why quantitative signal detection?
Measures of disproportionality (PRR, ROR, MGPS, BCPNN)
Regulatory and industry activity (including EudraVigilance)

EVDAS and the EU

The PRAC and signals
The EVDAS system
Signals arising from EVDAS

Risk-benefit analysis

Calculating the extent of benefit by indication
Identifying significant product risks
Benefit-risk assessments
Benefit-risk outcomes

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Graeme Ladds
PharSafer Associates Ltd

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.

More details

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

1-2 July 2024

Live online

09:00-16:30 UK (London) (UTC+01)
10:00-17:30 Paris (UTC+02)
04:00-11:30 New York (UTC-04)
Course code 13799

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 27 May

2 days 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

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Not ready to book yet?

for 7 days, no obligation

12-15 November 2024

Live online

13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14031

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 08 Oct

4 sessions of 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

View basket

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.