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

23-24 May 2019

& 25-26 Nov 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

Featuring signal evaluation for both innovator and generic products under the newly revised Module IX Signal Management and quantitative assessments.

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 that Companies need 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 newly revised Module IX Signal Management and quantitative assessments.

Benefits in attending

  • Clarify the EU regulatory requirements for signal detection
  • Understanding the new frequency requirements for safety review
  • How to use the Eudravigilance quantitative signal tool
  • Understand the safety review cycle and the safety review meeting and process
  • 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 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.

Programme - Day one

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 a safety review signal trackers
  • Information and templates for safety review
  • 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 and withdrawals

Safety assessments life cycle continued

The regulatory requirements for signal detection – Module IX

  • The frequency of safety reviews (risk assessment)
  • The EU and signal detection requirements
  • The USA requirements for signal detection
  • 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

Programme - Day two

Quantitative and qualitative signal detection

  • 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


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.

Book now

23-24 May 2019
23-24 May 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
25-26 Nov 2019
25-26 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Celltrion Inc.
  • Dechra Ltd
  • Dermal Laboratories Ltd
  • DI RENZO S.n.c.
  • Di Renzo SRL
  • Eisai Europe Limited
  • Faes Farma
  • Genethics Regulatory Services
  • Grupo Ferrer Interancional
  • Intervet International BV MSD Animal Health
  • LEO Pharma A/S
  • Medical Products Agency
  • Merck Selbstmedikation GmbH
  • Pharmacovigilance Matters Limited
  • Pharmvit Ltd
  • Pierre Fabre
  • Redline Pharmacovigilance Ltd
  • Regulis Consulting Ltd
  • Research and Markets
  • Roche Products Ltd - WELWYN GARDEN CITY, Hertfordshire
  • Santen Oy
  • Statens Serum Institut
  • Veterinary Medicines Directorate
  • Zentiva Group AS
  • Zentiva ks
  • Zoetis
  • Zoetis Belgium S.A.

A very useful course

Elisabetta Parretta, Drug Safety Officer, Faes Farma

A very useful course

Elisabetta Parretta, Drug Safety Officer, Faes Farma

The slides were a bit overloaded. Other than that, just great.

Katja Funke, Head of Safety Risk Management, Merck Selbstmedikation GmbH

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

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

Excellent throughout

Penuşa Stroia, Head of Regulatory Affairs , Genethics Regulatory Services

Very lively and complete

Violaine de la Tourette, Safety Officer Associate, Pierre Fabre

Very good

Chiara Bertarello, Deputy of QPPV, PROGE MEDICA SRL