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Joint MHRA/MedDRA Information Day - MedDRA in the Pharmacovigilance Regulatory Process

Dec 8 2014 8:45AM - Dec 8 2014 5:00PM | Holiday Inn London Kensington Forum 97 Cromwell Road London SW7 4DN United Kingdom

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Overview 

The Medical Dictionary for Regulatory Activities (MedDRA) terminology is designed to assist the sharing, assessment and evaluation of medical information in relation to the authorisation, the safety monitoring and continuous benefit risk assessment of medicines.


This Information Day will provide attendees with a highlight of the latest MedDRA initiatives and developments. This will include an outline of various efforts of the MedDRA MSSO to support interoperability of MedDRA with other terminologies, specifically in the healthcare domain, and the use of MedDRA in coding and analysing medication errors. 


The use of social media and other emerging technologies in pharmacovigilance and the potential role of MedDRA in facilitating data capture and analysis will also be one of the key topics of the meeting.


In addition, practical aspects on the use of MedDRA in the context of the new ICH E2B(R3) ICSR format will be outlined thus allowing participants to obtain a better understanding of the impact on their future coding processes.

 

This will be complimented by an outline by the MHRA of frequently observed coding mistakes as part of the current ICSR reporting practices. The Information Day will conclude with a session that is dedicated to the use of MedDRA for signal detection and data analysis both from a regulator’s and the industry's perspective.

 

What You Will Learn 

  • MedDRA in the context of the use of social media and other emerging technologies in pharmacovigilance
  • MedDRA and interoperability efforts in the healthcare domain
  • Review of MedDRA scope and potential impact on MedDRA users
  • Use of MedDRA for coding of medication errors
  • Frequently observed coding errors by MHRA as part of ICSRs reporting
  • Use of MedDRA for signal detection and data analysis
  • Practical MedDRA coding aspects in the context of the new ICH E2B(R3) ICSR

Who Should Attend 

This programme will benefit Qualified Persons Responsible for Pharmacovigilance (QPPVs) and individuals involved in:

  • Pharmacovigilance
  • Coding of ICSRs
  • Signal detection and evaluation
  • Clinical development
  • Safety databases

Contact Information 

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

Agenda and Event Logistics
Karin Gamba-Blessing, Event Manager
Phone: +41 61 225 51 61
Fax: +41 61 225 51 52
karin.gamba@diaeurope.org

Hotel & Travel 

DIA has blocked a limited number of rooms at the following hotel:

Holiday Inn London – Kensington Forum
97 Cromwell Road
SW7 4DN London
United Kingdom

Tel.: +44 207 341 8000
Website: http://www.hikensingtonforumhotel.co.uk/

at the rate of:
GBP 157.00 per room/night inclusive of breakfast and VAT.

In order to make your reservation, please contact the hotel directly at + 44 (0) 207 341 3355 and quote the booking reference P0N.

Important: The room rate is available until 20 October 2014 or until the group block is sold-out, whichever comes first.

Faculty 

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Agenda  

Day 1 Monday, Dec 08, 2014

  • 8:45AM - 9:00AM (GMT Standard Time)

    REGISTRATION
  • 9:00AM - 9:15AM (GMT Standard Time)

    WELCOME NOTE

    Speaker(s):

    • Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
  • 9:15AM - 10:45AM (GMT Standard Time)

    Session 1: MedDRA Developments to Meet New Pharmacovigilance Needs


    Session Chair(s):

    • Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Patrick Revelle
      Director, MedDRA MSSO
      Northrop Grumman Corporation, United States

    This session will provide an update on recent activities to ensure the continuing development of MedDRA to meet evolving pharmacovigilance needs and will focus on the coding and analysis of medication errors, off label use, and product quality issues

    Speaker(s):

    • Scope of MedDRA – update on the Blue Ribbon Panel Meeting
      Judy Harrison, MD
      Chief Medical Officer
      MedDRA MSSO, United States
    • Use of MedDRA for coding Medication Errors in ICSRs
      Victoria Newbould
      Scientific Officer
      European Medicines Agency, United Kingdom
    • How the MedDRA hierarchy can help – retrieving medication errors, off label use, and product quality issues
      Judy Harrison, MD
      Chief Medical Officer
      MedDRA MSSO, United States
  • 10:45AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:45PM (GMT Standard Time)

    Capturing new data resources in Pharmacovigilance


    Session Chair(s):

    • Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Patrick Revelle
      Director, MedDRA MSSO
      Northrop Grumman Corporation, United States

    This session will look at the possibilities of harnessing social media data to inform pharmacovigilance activities and address the activities taking place to ensure natural language from these data can be mapped to the MedDRA hierarchy.

    Speaker(s):

    • Building a dictionary to translate internet vernacular to MedDRA
      Nabarun Dasgupta, PhD, MPH
      President; Research Scientist, UNC at Chapel Hill
      Epidemico, Inc. , United States
    • How MedDRA could support data analytics in the context of the IMI WEB RADR project
      Patrick Revelle
      Director, MedDRA MSSO
      Northrop Grumman Corporation, United States
    • Harnessing Social Media for Pharmacovigilance – view from the industry
      Tjark Reblin
      VP Safety Evaluation and Risk Management – UK Development
      GlaxoSmithKline, United Kingdom
  • 12:45PM - 1:30PM (GMT Standard Time)

    LUNCH
  • 1:30PM - 3:00PM (GMT Standard Time)

    New ICH E2B(R3) ICSR and MedDRA coding


    Session Chair(s):

    • Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Patrick Revelle
      Director, MedDRA MSSO
      Northrop Grumman Corporation, United States

    This session will provide explanations on how to use MedDRA in the new ICH E2B (R3) format in the context of the electronic reporting of adverse reactions in the EU. The expected benefits and the impact on the pharmacovigilance business processes will be highlighted. This will be followed by a discussion MedDRA coding best practices from a regulatory perspective and will include the highlights of a survey of industry users on MedDRA coding practices.

    Speaker(s):

    • How to use MedDRA in the new ICH ICSR E2B(R3) format
      Gaby L. Danan, MD, PhD
      Pharmacovigilance Expert
      Gaby L Danan, France
    • MedDRA coding best practices from a regulatory perspective
      Jan Tahira
      MHRA, United Kingdom
    • Results of MedDRA Coding Practices Survey
      Barry Hammond
      Data Standards & Medical Coding Consultant
      Terminologeze Ltd, United Kingdom
  • 3:00PM - 3:30PM (GMT Standard Time)

    COFFEE BREAK
  • 3:30PM - 5:00PM (GMT Standard Time)

    MedDRA for signal detection and data analysis


    Session Chair(s):

    • Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Patrick Revelle
      Director, MedDRA MSSO
      Northrop Grumman Corporation, United States

    This session will provide important insight into the use of MedDRA for signal detection and data analysis including an overview of the key aspects described in the ICH-endorsed “MedDRA Data Retrieval and Presentation: Points to Consider” document. Various approaches to data analysis such as the use of the MedDRA hierarchy and secondary System Organ Class (SOC) analyses will be presented. Standardised MedDRA Queries and their application in case identification and signal detection will be discussed. The presentations will provide both a regulatory and industry perspective on this topic.

    Speaker(s):

    • Use of MedDRA in signal detection and evaluation
      Phil Tregunno
      Signal Management Unit Manager
      MHRA, United Kingdom
    • Safety signals, data retrieval and analysis – industry perspective
      Christina Winter
      GSK, United Kingdom

Registration Fees 

Other Fees

Charitable Nonprofit/Academia Member
€250.00
Government (Full Time)
€250.00
Industry
€500.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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