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Signal Detection and Regulatory Expectations Training Course: face to face & live webinar

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

2-3 Nov 2020

& 3-4 May 2021 , 1-2 Nov 2021

Book now

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.

Programme - day 1

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

Programme - day 2

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

Presenter

Graeme Ladds (More...)

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

  attend Face to face attend Live webinar
2-3 Nov 2020, Rembrandt Hotel, London
2-3 Nov 2020 Rembrandt Hotel, London GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 21 Sep*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 21 Sep*
Enrol now
to attend
Live webinar
3-4 May 2021, Venue not yet confirmed
3-4 May 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 22 Mar 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 22 Mar 21*
Enrol now
to attend
Live webinar
1-2 Nov 2021, Venue not yet confirmed
1-2 Nov 2021 Venue not yet confirmed GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 20 Sep 21*
Enrol now
to attend
Face to face
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 20 Sep 21*
Enrol now
to attend
Live webinar

Learn more about our different training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Aspen Pharma Trading Ltd
  • Blue Earth Diagnostics
  • Celltrion Inc.
  • DI RENZO S.n.c.
  • Eisai Europe Limited
  • Ewopharma International, s.r.o.
  • Faes Farma S.A.
  • Ferring Pharmaceticals A/S
  • Ferring Pharmaceuticals A/S
  • Genethics Regulatory Services
  • Grupo Ferrer Internacional SA
  • Intervet International BV MSD Animal Health
  • Ipsen Innovation - Comptabilité Fournisseurs
  • Italfarmaco
  • Medical Products Agency
  • Merck Selbstmedikation GmbH
  • Norgin
  • Pfizer
  • Pharmacovigilance Matters Limited
  • PROGE MEDICA SRL
  • Redline Pharmacovigilance Ltd
  • Regulis Consulting Ltd
  • Roche Products Ltd - WELWYN GARDEN CITY, Hertfordshire
  • Santen Oy
  • Saudi Food and Drug Authority
  • STALLERGENES SAS
  • Therabel Lucien Pharma
  • Zentiva
  • Zentiva Group AS
  • Zoetis Belgium S.A.

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 19

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 19

Well delivered training with good background information.

Trevor Smith, Medical Affairs Officer, Hameln Pharmaceuticals Ltd, Nov 19

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 19

The speaker is confident and clearly knows the subject well.

Christopher Harper, Pharmacovigilance and Medical Information Manager, Blue Earth Diagnostics, Nov 19

Comprehensive content, understandable presentations and a speaker with extensive experience.

Anne Kjøde, Medical Advisor/ QPPV, Karo Pharma AS, Nov 19

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 19

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, May 19

Excellent course, highly recommended and the topics were well suited for the particular area

Anna Fernandez-Saranillo, Drug Safety Specialist, Roche Products, Nov 18

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 18

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 18

A very useful course

Elisabetta Parretta, Drug Safety Officer, Faes Farma, May 18

A very useful course

Elisabetta Parretta, Drug Safety Officer, Faes Farma, May 18

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 17

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

Katja Funke, Head of Safety Risk Management, Merck Selbstmedikation GmbH, Nov 17