Signal Detection and Risk Management

Learn the principles of signal detection, signal management and risk management

27 Nov - 1 Dec 2023

On location

Danish

30,000 DKK ex VAT

(app. 4,033 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

This accredited course (ECTS 5), offered in collaboration with University of Copenhagen, covers principles of signal detection, signal management and risk management. We begin at the initial detection of potential signals in different data sources and continue through the signal management process to signal validation and assessment of the benefit-risk balance.

The course also deals with risk management, risk minimisation activities and risk communication. We cover the aspects of regulations, roles and responsibilities of the marketing authorisation holder, regulatory authorities, ethics committees, HCPs, and patients.


Teaching methods:

  • Online part: e-lessons that introduce you to the concepts of signal detection, signal management, and risk management.
  • On location part: lectures and group work on real and simulated safety scenarios.

    KEY WORDS

    • Data sources
    • Methods for signal detection
    • Signal management
    • Risk management

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    Course leader(s) & Lecturer(s)

    • Morten Andersen
      Course leader
      Professor in Pharmacovigilance
      University of Copenhagen
    • Maurizio Sessa
      Lecturer
      Assistant professor
      Københavns Universitet
    • Wasim Anwar
      Lecturer
      Vice President & Deputy QPPV, Global Safety
      Novo Nordisk A/S
    See all

    IS THIS COURSE FOR YOU?

    This course is valuable for all experienced pharmacovigilance professionals, e.g. safety surveillance advisers, safety scientists, and patient safety associates.

    What you will learn

    1. How to explain and describe data sources and methods for signal detection.
    2. How to describe relevant information flows, legislation and guidelines on signal management and risk management.
    3. How to explain key concepts related to signal management and risk management.
    4. How to explain and describe the roles and responsibilities of regulatory agencies and marketing authorisation holders.

    What your company will get

    1. An employee who can independently integrate and evaluate safety information from various sources.
    2. An employee who can critically assess information and reflect on the appropriate actions to take.
    3. An employee who can develop a strategy for risk management.
    4. An employee who can plan risk minimisation activities and risk communication for different safety scenarios.

    Course calendar

    Starting 27 Nov 2023
    27 Nov 2023 9:00-16:00

    Day 1

    Sources of data for signal detection

    • Welcome, presentation of Course Leaders and participants
    • Spontaneous reporting systems
    • Safety reporting in clinical trials
    • Other solicited data sources and external data bases
    • Qualitative versus quantitative signal detection
    • Disproportionality methods
    • Workshop - Signal detection case example
    28 Nov 2023 9:00-16:00

    Day 2

    Regulatory requirement and Signal Management

    • Summary day 1 & intro to day 2
    • Module IX. Signal prioritisation, validation, and assessment and reporting Case from the industry
    • Module IX .Signal prioritization, validation and reporting assessment
      Case from the authorities
    • Quiz signal management
    • Signal detection at WHO/authorities
    • Advanced methods for signal detection
    • Workshop - Case Signal Management
    29 Nov 2023 9:00-16:00

    Day 3

    Risk Management

    • Summary day 2 & intro to day 3
    • Definition of risk and risk management
    • Development of the risk management plan
    • Benefit-risk assessment
    • Signals in big data
    • Introduction to workshop through cases
    • Workshop – Risk management examples
    30 Nov 2023 9:00-16:00

    Day 4

    Regulatory requirements for Risk Managements

    • Summary day 3 & intro to day 4
    • Risk managements plans GVP Module V
    • Global requirements (ex EU)
    • Quiz risk management
    • Introduction to workshop
    • Workshop
    • QA session
    1 Dec 2023 9:00-16:00

    Day 5

    Risk minimizations / mitigation

    • Summary day 4 & intro to day 5
    • Risk communication
    • Risk minimization strategies
    • PASS and risk minimization
    • Introduction to workshop through cases
    • Assessing the effectiveness of risk minimization initiatives
    • Wrap up and evaluation of the course
    Practical information

    Registration

    Registration deadline
    18 Sep 2023
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    27 Nov - 1 Dec
    Sometimes things change. This is the expected programme.

    Course information

    Literature

    Prior to the course you get access to mandatory and optional readings via your personal Atrium log-in. Please familiarise yourself with the mandatory readings before starting the course. The mandatory readings are also part of the examination syllabus.

    Readings include selected chapters from textbooks, including Mann’s Pharmacovigilance (current edition) as well as relevant legislation, including EU directives and regulations, good pharmacovigilance practice guidelines, scientific papers and review papers.

    Prerequisites

    Applicants must meet the following criteria:

    • A relevant BA degree or equivalent
    • A minimum of 2 years of relevant job experience

    Examination

    The exam is a written assignment and takes place digitally (the online exam platform of the University of Copenhagen).

    Date: 22 December 2022

    Course leader(s)

    Morten Andersen
    Professor in Pharmacovigilance
    University of Copenhagen

    Lecturer(s)

    Maurizio Sessa
    Assistant professor
    Københavns Universitet
    Morten Andersen
    Professor in Pharmacovigilance
    University of Copenhagen
    Wasim Anwar
    Vice President & Deputy QPPV, Global Safety
    Novo Nordisk A/S

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    Want to know more or need help?

    Contact Educational Programme Leader Lone Rex at +45 20 62 11 46

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