Presented by
Management Forum
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
12-15 November 2024
+ 17-18 March 2025, 7-8 July 2025, 18-21 November 2025 »
from £1099
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.
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.
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.
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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
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
Until 08 Oct
Not ready to book yet?
for 7 days, no obligation
17-18 March 2025
Live online
09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
05:00-12:30 New York (UTC-04)
Course code 14597
Until 10 Feb
Not ready to book yet?
for 7 days, no obligation
7-8 July 2025
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 14785
Until 02 Jun
Not ready to book yet?
for 7 days, no obligation
18-21 November 2025
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 15063
Until 14 Oct
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.
United Kingdom
France
United States of America
Denmark
Spain
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Czech Republic
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Norway
Romania
Saudi Arabia
Slovak Republic
Sweden
Switzerland
Canada
Ireland
Korea, Republic Of
Lithuania
Poland
2 days
Typical duration
Pricing from:
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:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: