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1st EMA MedDRA Information Day

Oct 22 2013 8:45AM - Oct 22 2013 5:00PM | European Medicines Agency Canary Wharf, 7 Westferry Circus London E14 4HB United Kingdom

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Overview 

The Medical Dictionary for Regulatory Activities (MedDRA) terminology is designed for sharing regulatory information for human medicinal products. The latest versions of two ICH-Endorsed Guides for MedDRA users were published beginning of April 2013: "MedDRA Term Selection: Points to Consider" and "MedDRA Data Retrieval and Presentation: Points to Consider". Both were developed by a working group consisting of experts from the MedDRA MSSO, regulatory and industry representatives of the EU, Japan and the US, as well as representatives from the Canadian regulatory authority and were updated based on MedDRA version 16.1.

This Information Day will focus specifically on the use of MedDRA for coding and retrieving clinical and pharmacovigilance data including medication errors. Discussions will be led by experts from regulatory authorities, the MedDRA MSSO and pharmaceutical industry. The use of MedDRA in the context of EudraVigilance and other international databases will be also addressed.

Attendees are invited to submit specific coding or data retrieval questions by 1st October 2013 to EudraVigilance@ema.europa.eu , subject: 1st MedDRA Information Day

Who Should Attend 

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

  • Pharmacovigilance
  • MedDRA coding
  • Signal detection and evaluation
  • Clinical development
  • Safety databases

Learning Objectives 

At the end of this Information day, participants should be able to:

  • Identify the latest developments in MedDRA
  • Apply MedDRA for coding and reporting of ICSRs including those occurring in the context of a medication error
  • Evaluate to use of MedDRA for signal detection
  • Recognize the use of MedDRA in the context of EudraVigilance
  • Improve coding and analysis based on specific examples

Featured Topics 

  • Practical use of MedDRA for coding purposes including those associated with medication errors
  • Practical use of MedDRA for coding of overdose, misuse, abuse, off label use, and occupational exposure
  • Practical use of MedDRA for data retrieval, signal detection and evaluation including the use of Standardised MedDRA Queries (SMQs)
  • Use of MedDRA in the context of EudraVigilance and other large databases

Contact Information 

Registration and Agenda:
DIA Europe
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
E-mail: diaeurope@diaeurope.org

Hotel & Travel 

HOTEL INFORMATION
Attendees have to make their own reservation. Recommended hotel close to the EMA:

Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
United Kingdom

Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
Email: reservations.docklands@hilton.com

Special negotiate rate for participants to the Information Day for a limited number of rooms is GBP 139.00 per room (2013 rate) incl. breakfast excl. VAT. To book a room, please send an email to Ms. Liane Lopes at Liane.Lopes@Hilton.com or call her at +44 203 002 2350.

The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the EMA (2 min).

TRAVEL INFORMATION
The training course takes place at the

European Medicines Agency (EMA)
7 Westferry Circus
Canary Wharf
London E14 4HB
Web site: www.ema.europa.eu
Please click here for a map on how to find the EMA.
Please click here for some useful transport information.

For the special security access procedure to enter the EMA building, please calculate a delay of up to 10-15 minutes. It is not possible to enter the building before 8.00 am.

Faculty 

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Agenda  

Day 1 Tuesday, October 22, 2013

  • 9:00AM - 9:30AM

    Highlights of MedDRA and the developmental activities


    Session Chair(s):

    • Patrick Revelle
      Director
      MedDRA MSSO, United States

    Session 1 will provide a brief overview of the evolution of MedDRA to meet the needs of users. This includes a discussion of several initiatives including medication error terms, device terms, product quality issue terms, vaccine terms, microorganism terms, terms related to chemical health threats, pharmacogenetic terms, and neoplasm terms. A brief discussion of the process to add these various types of terms within the scope of MedDRA will also be discussed.

    Speaker(s):

    • Highlights of MedDRA and the developmental activities
      Patrick Revelle
      Director
      MedDRA MSSO, United States
  • 9:30AM - 10:30AM

    MedDRA terms selection for coding of ICSRS


    Session Chair(s):

    • Sabine Brosch, PharmD,PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    Session 2 will focus on the use of MedDRA to code clinical data. Following an overview of the “key principles in the ICH-endorsed MedDRA Term Selection: Points to Consider” document, the practical use of MedDRA in coding will be discussed based on various examples from both an industry and regulatory perspective. Specific questions from the audience will be addressed as part of a panel discussion.

    Speaker(s):

    • Overview of the MedDRA Term Selection Points to Consider Document and Key Coding Principles
      Judy Harrison, MD
      Chief Medical Officer
      MedDRA MSSO, United States
    • A Pharmaceutical Industry Perspective in Coding Clinical Trials and Post-authorisation Data
      Christina Winter
      GSK, United Kingdom
    • A Regulator’s Perspective in Coding with MedDRA and Practical Examples
      Sarah Vaughan
      Pharmacovigilance Information Unit Manager
      MHRA, United Kingdom
    • Discussant
      Barry Hammond, MSc
      European MedDRA User Group
      Terminologeze Ltd, United Kingdom
    • Gaby L. Danan, MD,PhD
      Pharmacovigilance Expert
      France
  • 11:00AM - 12:30PM

    Use of MedDRA for signal detection and data analysis


    Session Chair(s):

    • Georgy Genov, MD
      Head of Signal Management
      European Medicines Agency (EMA), United Kingdom

    Session 3 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. Specific questions from the audience will be addressed as part of a panel discussion.

    Speaker(s):

    • Overview of the MedDRA Data Retrieval and Presentation: Points to Consider document including Standardised MedDRA Queries (SMQs)
      Judy Harrison, MD
      Chief Medical Officer
      MedDRA MSSO, United States
    • MedDRA for signal detection in EudraVigilance
      Aniello Santoro
      European Medicines Agency, United Kingdom
    • MedDRA for signal detection by Health Canada
      Heather Sutcliffe
      Director, Marketed Health Products Safety & Effectiveness Information Bureau
      Health Canada, Canada
  • 1:30PM - 3:00PM

    Use of MedDRA for coding and analysis of medication errors


    Session Chair(s):

    • Sabine Brosch, PharmD,PhD
      Monitoring and Incident Management, Pharmacovigilance
      European Medicines Agency, European Union, United Kingdom

    Session 4 will focus on challenges in coding patient safety data based on specific examples of medication error reports and how this can be addressed using MedDRA. Important onsiderations in relation to handling of medication errors and product quality issues will be presented from an FDA perspective. Coding, analysis and data presentation of medication errors in the context of risk management and pharmacovigilance will be also addressed. Actions agreed as a result of the Medication Error Workshop held at the EMA in February 2013 will conclude the discussions of this Information Day. Specific questions from the audience will be addressed as part of a panel discussion.

    Speaker(s):

    • A Patient Safety Perspective of Medication Error Incident Reports and Coding Challenges
      David Cousins
      National Patient Safety Agency, United Kingdom
    • MedDRA Coding of Medication Error Incident Reports Based on Practical Examples
      Sarah Vaughan
      Pharmacovigilance Information Unit Manager
      MHRA, United Kingdom
    • Medication Errors
      Heather Sutcliffe
      Director, Marketed Health Products Safety & Effectiveness Information Bureau
      Health Canada, Canada
    • Medication Errors versus Quality Issues
      Sonja Brajovic, MD
      Medical Officer, CDER
      FDA, United States
  • 3:30PM - 4:30PM

    Session 4 cont.

    Speaker(s):

    • Coding, Analysis and Data Presentation of Medication Errors from a Pharmaceutical Industry Perspective
      Christina Winter
      GSK, United Kingdom
    • Follow up from EMA Medication Error Workshop and Next Steps
      Thomas Goedecke
      Pharmacovigilance and Risk Management Sector
      European Medicines Agency, United Kingdom
    • Medication Errors Q&A Session
      Barry Hammond, MSc
      European MedDRA User Group
      Terminologeze Ltd, United Kingdom

Registration Fees 

Other Fees

Academia
€180.00
Government (Full Time)
€180.00
Industry
€365.00
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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