Presented by
Management Forum

Signal Detection and Regulatory Expectations

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 Nov 2021 + 3 more dates

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

Course overview

Including the updated Signal Module IX and EudraVigilance quantitative signal requirement

Increasingly, the most common critical findings in regulatory inspections are being given for signal detection and 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 signal management and quantitative assessments.

Benefits of attending:

  • Clarify the EU regulatory requirements for signal detection
  • Learn to use the EudraVigilance quantitative signal tool
  • Understand the safety review cycle and the safety review meeting and process
  • Understand EVDAS functionalities and outputs
  • Discuss safety communication – the CCSI/SCSI and labelling
  • Gain a better understanding of risk-benefit analysis – benefit-risk assessments and benefit-risk outcomes

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

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

1-2 Nov 2021

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 11058

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

In your basket 

22-23 Feb 2022

Classroom
London venue TBC

00:00-00:00 UK (London)
Course code 11420

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 18 Jan

  • 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

In your basket 

16-17 May 2022

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 11617

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 11 Apr

In your basket 

29-30 Nov 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11752

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 25 Oct

In your basket 

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


Very In depth training - all though a lot of theoretical stuff. Overall good for me.

May 4 2021

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

UK

  • 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 Pharmaceuticals Ltd
  • Ipsen
  • Meda Pharmaceuticals Limited
  • Mitsubishi Tanabe Pharma Europe
  • Nelsons
  • Norgine
  • Norgine Ltd
  • 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
  • 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

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

Spain

  • Faes Farma
  • Faes Farma S.A.
  • Grupo Ferrer Interancional
  • Grupo Ferrer Internacional SA

Belgium

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

Finland

  • OY Medfiles LTD
  • Santen Oy

Germany

  • CHEPLAPHARM Arzneimittel GmbH
  • Merck Selbstmedikation GmbH

Norway

  • GE Healthcare AS
  • Karo Pharma AS

Saudi Arabia

  • Saudi FDA
  • Saudi Food and Drug Authority

Sweden

  • AstraZeneca
  • Medical Products Agency

Switzerland

  • Idorsia Pharmaceuticals Ltd
  • Idorsia Pharmaceuticals Ltd.

United States of America

  • GE Healthcare
  • SafePharm LLC

Ireland

  • Aspen Pharma Trading Ltd

Korea, Republic Of

  • Celltrion Inc.

Netherlands

  • Intervet International BV MSD Animal Health

Poland

  • Pfizer

Slovak Republic

  • Ewopharma International, s.r.o.

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Multiple colleagues?
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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