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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

22-23 Feb 2022

& 16-17 May 2022 , 29-30 Nov 2022

Book now

Details

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

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

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

Book now

22-23 Feb 2022
Face-to-face, (venue not yet confirmed)
22-23 Feb 2022
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 18 Jan 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
16-17 May 2022
Live webinar
16-17 May 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 11 Apr 22*
Enrol now
to attend
Live webinar
29-30 Nov 2022
Live webinar
29-30 Nov 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 25 Oct 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

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

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Alfasigma S.p.A.
  • Aspen Pharma Trading Ltd
  • Astellas Pharma Europe Ltd
  • Ceva
  • Chiesi Ltd
  • Di Renzo SRL
  • Eisai Europe Limited
  • Ewopharma International, s.r.o.
  • Ferring Pharmaceuticals
  • Grupo Ferrer Internacional SA
  • GW Pharmaceuticals
  • Hameln Pharmaceuticals Ltd
  • Karo Pharma AS
  • LEO Pharma
  • LEO Pharma A/S
  • Nelsons
  • Norgine
  • OY Medfiles LTD
  • Pfizer
  • Pharmacosmos UK
  • Pierre Fabre
  • Poxel
  • Recordati Rare Diseases
  • Roche Products Ltd - WELWYN GARDEN CITY, Hertfordshire
  • Santen Oy
  • Saudi Food and Drug Authority
  • Transgene S.A.
  • Zentiva
  • Zentiva Group AS
  • Zoetis

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

Augustina Kanu, Pharmacovigilance, Chiesi Ltd, May 21

The speaker is confident and clearly knows the subject well.

Christopher Harper, Senior Medical Information Manager, Astellas Pharma Europe Ltd, Nov 19

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

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

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

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

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

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

Well delivered training with good background information.

Trevor Smith, Medical Affairs Officer, Hameln Pharmaceuticals Ltd, 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

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

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

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