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Signal Management in Pharmacovigilance

Nov 3 2014 9:30AM - Nov 4 2014 12:20PM | Hotel Novotel Paris Charenton 3-5 place des Marseillais 94227 Charenton Le Pont, Paris France

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Overview 

ATTENTION: PUBLIC TRANSPORT STRIKE PLANNED ON 4 NOVEMBER 2014!

Signal Management is a critical process of Pharmacovigilance required by EU Good Pharmacovigilance Practice. It is the scientific component that underpins Pharmacovigilance, and the very reason why Pharmacovigilance was created in the first place.

The entire course has been updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX - Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII.

Time has been set aside for exercises, questions and discussions.

The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions. Data mining techniques for large volume ADR data analysis and relevant EMA guidelines will also be a discussed, as well as a future outlook.

What the participants from previous Signal Management courses say:

"Very good presentations, clear explanations and useful, partial examples. All exercises were well chosen and useful for my daily notice"

"Good combination of information and exercises, and interaction throughout"

"Excellent knowledge, open to questions, ready to assist and to provide additional explanations"

Who Should Attend 

Professionals who work in:
  • Pharmacovigilance (including QPPV)
  • Drug safety and patient safety Risk Management
  • Pharmacoepidemiology
  • Information Technology
  • Regulatory Affairs
  • Pharmacovigilance consultancy
  • Quality and Compliance
  • Legal

Course level: Intermediate, for professionals with 2-3 years of experience in Pharmacovigilance.

Learning Objectives 

At the conclusion of this course, participants should be able to:
    • Explain and design the signal management process for companies of various sizes, portfolios and geographical presence
    • Explain and apply the basic concepts and principles of signal detection in Pharmacovigilance, including the role and differences of classical and statistical signal detection in the ongoing safety surveillance of medicinal products
    • Outline how to apply signal detection within their function based on the possibilities and limitations of methodology, data and resources
    • Employ data mining techniques to analyse large volumes of adverse event report data
    • Discuss key messages from the EMA Guideline on the uses of statistical signal detection methods in the Eudravigilance Data Analysis System, Module IX of EU GVP and CIOMS VIII
    • Understand and manage implications of Pharmacovigilance signals for the future of pharmaceutical companies and products

    Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

    Hotel & Travel 

    Course venue
    Novotel Paris Charenton
    3-5 place des Marseillais
    94227 Charenton-le-Pont
    France
    Tel +33 1 46 76 60 60
    Fax +33 1 49 77 68 00
    E-mail H1549@accor.com
    Website

    To book the hotel room please contact the hotel directly for the availability and the best rate.
    The Hotel Novotel Paris Charenton is located 10 minutes from Gare de Lyon train station. Take the Metro Line 1 towards Chateau de Vincennes or Metro Line 5 towards Marne-la-Vallee / Boissy-St-Leger and get off at Reuilly-Diderot (1 stop). Change to Metro Line 8 towards Pointe du Lac and get off at Liberte (6 stops). The hotel is located opposite of Metro station. For more information, please visit the hotel website.

    Contact Information 

    Registration Questions
    DIA Europe, Middle East and Africa
    Contact Center
    Phone.: +41 61 225 51 51
    Fax: +41 61 225 51 52
    Monday-Friday 8:00-17:00 CET
    diaeurope@diaeurope.org

    Agenda and Event Logistics
    Gunta Sveke, Event Manager
    Phone: +41 61 225 51 55
    gunta.sveke@diaeurope.org

     

    Faculty 

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    Agenda  

    Day 1 Monday, Nov 03, 2014

    • 9:30AM - 10:00AM (Central Europe Standard Time)

      REGISTRATION
    • 10:00AM - 12:00PM (Central Europe Standard Time)

      Session 1: SIGNAL DETECTION – THEORY, METHODS, REGULATORY BASIS
    • 12:00PM - 1:00PM (Central Europe Standard Time)

      LUNCH
    • 1:00PM - 3:00PM (Central Europe Standard Time)

      Session 2: SIGNAL DETECTION – APPLICATION AND WORKSHOP
    • 3:00PM - 3:30PM (Central Europe Standard Time)

      COFFEE BREAK
    • 3:30PM - 5:30PM (Central Europe Standard Time)

      Session 3: DATA MINING – THEORY AND METHODS
    • 5:30PM - 6:30PM (Central Europe Standard Time)

      DRINKS RECEPTION

    Day 2 Tuesday, Nov 04, 2014

    • 8:30AM - 10:00AM (Central Europe Standard Time)

      Session 4: DATA MINING – APPLICATION
    • 10:00AM - 10:30AM (Central Europe Standard Time)

      COFFEE BREAK
    • 10:30AM - 12:00PM (Central Europe Standard Time)

      Session 5: SIGNAL MANAGEMENT PROCESS, METHODS, REGULATORY
    • 12:00PM - 12:20PM (Central Europe Standard Time)

      COURSE ASSESSMENT

    Registration Fees 

    Member

    Charitable Nonprofit/Academia Member
    €605.00
    Member Government
    €605.00
    Member Standard
    €1210.00

    Non-Member

    Charitable Nonprofit/Academia Nonmember
    €735.00
    NonMember Government
    €735.00
    NonMember Standard
    €1340.00
    Register Online
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