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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

★★★★★ "Well delivered training with good background information."

29-30 Nov 2022
+ 3 more dates

Need help?  Enrol or reserve

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

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

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.

Enrol or reserve

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

Enrol or reserve

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

Book Signal Detection and Regulatory Expectations Live online/Classroom training

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

29-30 Nov 2022

Live online

09:00-16:30 UK (London) (UTC+00)
10:00-17:30 Paris (UTC+01)
04:00-11:30 New York (UTC-05)
Course code 11752

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

Limited places remaining

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Not ready to book yet?

for 7 days, no obligation

17-18 Apr 2023

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 12161

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

Until 13 Mar

View basket 

 
Not ready to book yet?

for 7 days, no obligation

3-4 Jul 2023

Classroom
Rembrandt Hotel
London

Course code 12395

  • GBP 1,299 1,499
  • EUR 1,869 2,149
  • USD 2,137 2,449

Until 29 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

View basket 

 
Not ready to book yet?

for 7 days, no obligation

14-17 Nov 2023

Live online

Course code 12445

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

Until 10 Oct

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.

Reviews of IPI's Signal Detection and Regulatory Expectations training course


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!!

Nov 1 2021

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
Pharmacovigilance Manager , 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 Pharma Europe Ltd

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

United Kingdom

  • Astellas Pharma Europe Ltd
  • Chiesi Ltd
  • CRO
  • Dechra Ltd
  • Dermal Laboratories Limited
  • Dermal Laboratories Ltd
  • Diamond Pharma Services
  • Eisai Europe Limited
  • Genethics Regulatory Services
  • GW Pharma
  • GW Pharmaceuticals
  • hameln pharma ltd
  • Hameln Pharmaceuticals Ltd
  • Ipsen
  • Meda Pharmaceuticals Limited
  • Mitsubishi Tanabe Pharma Europe
  • Nelsons
  • Norgine
  • Norgine Ltd
  • Pharmacosmos UK
  • Pharmacovigilance Matters Limited
  • Pharmvit Ltd
  • Red Line Pharmacovigilance
  • Red Line Pharmacovigilance Ltd
  • Regulis Consulting Limited
  • Roche Products
  • Roche Products Ltd
  • The Boots Company PLC
  • Veterinary Medicines Directorate
  • Weleda

France

  • Anticipsante
  • Arrow Generics
  • BIOCODEX
  • Ceva Santé Animale
  • Ipsen
  • Pierre Fabre
  • Poxel
  • Recordati Rare Diseases
  • Stallergenes Greer plc
  • Therabel Lucien Pharma
  • Therabel Pharmaceuticals Ltd
  • Transgene S.A.

Denmark

  • Ferring Pharmaceticals A/S
  • Ferring Pharmaceutical A/S
  • Ferring Pharmaceuticals
  • LEO Pharma
  • LEO Pharma A/S
  • Novo Nordisk A/S
  • Statens Serum Institut

Spain

  • Asphalion
  • Faes Farma
  • Faes Farma S.A.
  • Grupo Ferrer Interancional
  • Grupo Ferrer Internacional SA
  • Pharma Mar SA
  • Pharma Mar, S.A.

Italy

  • Alfasigma S.p.A.
  • DI RENZO S.n.c.
  • Di Renzo SRL
  • Italfarmaco
  • PROGE MEDICA SRL

Czech Republic

  • Zentiva
  • Zentiva Group AS
  • Zentiva Group, a.s.
  • Zentiva ks

Germany

  • BioNTech SE
  • CHEPLAPHARM Arzneimittel GmbH
  • Merck Selbstmedikation GmbH
  • Otsuka Pharmaceutical Development & Commercialisation Europe GmbH

United States of America

  • Allucent
  • GE Healthcare
  • SafePharm LLC
  • SK Life Science

Belgium

  • GlaxoSmithKline Vaccines
  • Zoetis
  • Zoetis Belgium S.A.

Finland

  • OY Medfiles LTD
  • Santen Oy

Netherlands

  • Intervet International BV MSD Animal Health
  • Tiofarma BV

Norway

  • GE Healthcare AS
  • Karo Pharma AS

Romania

  • Ewopharma
  • Ewopharma AG

Saudi Arabia

  • Saudi FDA
  • Saudi Food and Drug Authority

Sweden

  • AstraZeneca
  • Medical Products Agency

Switzerland

  • Idorsia Pharmaceuticals Ltd
  • Idorsia Pharmaceuticals Ltd.

Ireland

  • Aspen Pharma Trading Ltd

Korea, Republic Of

  • Celltrion Inc.

Lithuania

  • State Medicines Control Agency of Lithuania

Poland

  • Pfizer

Slovak Republic

  • Ewopharma International, s.r.o.

Enrol or reserve

Run Signal Detection and Regulatory Expectations Live online/Classroom for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee
  • 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 expert Aleksandra Beer 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:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy