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
★★★★★ "Content and presentation very good. The presenter was excellent, knowledgeable in all topics"
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
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.
Very detailed and informative.
Jul 1 2024
Antonella Fusco
PV Medical Function, ALFASIGMA SPA
Jul 1 2024
It was excellent.
María Jesús Bermejo San Román
Pharma Mar, S.A.
Mar 18 2024
A good presentation with lot of examples. The speaker is well versed with the topic and pharmacovigilance practices. All other non-signal questions were also answered. Appreciate that
Sanam Chandwani
Manager Aggregate reports, Accord Healthcare
Nov 14 2023
Overall, the speaker was very competent and added a lot of real-world examples and thus enabled better understanding of the theory/regulatory requirements presented. He is an excellent trainer.
Daniela Bausewein
Associate Director Clinical Safety Management, BioNTech SE
Nov 29 2022
Content and presentation very good. The presenter was excellent, knowledgeable in all topics
María Jesús Bermejo San Román
Pharma Mar, S.A.
Nov 29 2022
The course was usefull for beginners and advanced PV officers.
Zainab Moussa
PV Officer, Tiofarma BV
Nov 29 2022
The content of the webinar exceeded my expectations. Great speaker with a lot of experience and knowledge, ready to answer any question.
Tamara Micakovic
Manager Pharmacovigilance, BioNTech SE
Nov 29 2022
The standard of this webinar was very high. Content and the presentation were very well prepared. Graeme is great expert. He was helping our company long time ago, and this is how I remembered him:-) Natural talent of explaining PV in digestible way ;-)
Marta Hennig
Manager Risk Evaluation and Reporting, Otsuka Pharmaceutical Development & Commercialisation Europe GmbH
Nov 29 2022
fantastic presentation
Venugopal Marar
Senior Medical Director Pharmacovigilance, SK Life Science
Nov 1 2021
The webinar was really interesting and helpful to better understand the signal management process! Graeme was a nice speaker who takes time to answer questions and explain in details all the topics covered by the webinar. Many thanks for these 2 days, really enriching!!
Justine Rohel
Surveillance Pharmacist, BIOCODEX
May 4 2021
Very In depth training - all though a lot of theoretical stuff. Overall good for me.
Augustina Kanu
Pharmacovigilance, Chiesi Ltd
Nov 25 2019
Well delivered training with good background information.
Trevor Smith
Medical Affairs Officer, Hameln Pharmaceuticals Ltd
Nov 25 2019
Excellent throughout. Graeme was very knowledgeable and engaging and the content was varied and at a good level.
Yasmy Kumar
Deputy QPPV, Red Line Pharmacovigilance
Nov 25 2019
Overall an excellent course – it flowed very well and the examples that were provided throughout were helpful.
Chrissa Cooper
Associate Director QPPV Office & PV Alliances , Norgine Ltd
Nov 25 2019
The speaker is confident and clearly knows the subject well.
Christopher Harper
Senior Medical Information Manager, Astellas Pharmaceuticals
May 23 2019
The speaker was well-experienced with in-depth knowledge in practical issues related to signals. Great show.
Torsten Schlüter
Senior PV Manager, CHEPLAPHARM Arzneimittel GmbH
Nov 25 2019
Comprehensive content, understandable presentations and a speaker with extensive experience.
Anne Kjøde
Medical Advisor/ QPPV, Karo Pharma AS
Nov 25 2019
Very interesting course with a good speaker. I particularly liked the global view of pharmacovigilance and its impact on signal management.
Chloé Dubarry
Pharmacovigilance Associate, Recordati Rare Diseases
Nov 25 2019
I was really happy with this course which was complete and well presented. The speaker really knew his subject and kept the course alive with personal examples which was really entertaining. The course gave me some valuable ideas that I could implement in our qualitative signal detection.
Caroline Riaud
Pharmacovigilance Associate, Ceva Santé Animale
Nov 26 2018
It was a good course, very informative with a very proficient speaker. The course content focussed on the concept of signals that then become risks. The presentation was very good and covered the topics well.
Adam Bedford
Pharmacovigilance Associate, GW Pharma
Nov 26 2018
Excellent course, highly recommended and the topics were well suited for the particular area
Anna Fernandez-Saranillo
Drug Safety Specialist, Roche Products
May 15 2018
A very useful course
Elisabetta Parretta
Drug Safety Officer, Faes Farma
May 15 2018
A very useful course
Elisabetta Parretta
Drug Safety Officer, Faes Farma
Nov 26 2018
Very good overall with interesting course content, well presented with thorough course notes and an engaging speaker.
Kari Karolia
Senior Pharmacovigilance Associate, GW Pharmaceuticals
Nov 9 2017
Graeme is an expert on signal detection and has a lot of practical examples to animate the substance matter. Content was of high quality.
Antti Miikki
Pharmacovigilance Specialist, Santen Oy
Nov 9 2017
It's comprehensive course and could help the PV workers in companies more than the ones who work in authorities.
Hajer Mohammed AlSaleh
Pharmacist , Saudi Food and Drug Authority
Nov 9 2017
The slides were a bit overloaded. Other than that, just great.
Katja Funke
Head of Safety Risk Management, Merck Selbstmedikation GmbH
Jun 9 2016
Excellent throughout
Penuşa Stroia
Head of Regulatory Affairs , Genethics Regulatory Services
Jun 9 2016
Very lively and complete
Violaine de la Tourette
Safety Officer Associate, Pierre Fabre
Jun 9 2016
Very good
Chiara Bertarello
Deputy of QPPV, PROGE MEDICA SRL
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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: