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Joint MHRA/EMA/MSSO 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 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.

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

Featured Topics 

  • Use of Social Media and other emerging Technologies
  • Results of Discussion on the Scope of MedDRA
  • Use of MedDRA for coding Medication Errors in ICSRs
  • Role of MedDRA in Non-ICSR PV activities
  • Use of MedDRA for signal detection and data analysis
  • MedDRA Interoperability, Code on mappings to other terminologies
  • New ICH E2B(R3) ICSR and MedDRA coding

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

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

    WELCOME NOTE
  • 9:15AM - 10:45AM (GMT Standard Time)

    Session 1
  • 10:45AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (GMT Standard Time)

    Session 2
  • 12:30PM - 1:30PM (GMT Standard Time)

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

    Session 3
  • 3:00PM - 3:15PM (GMT Standard Time)

    COFFEE BREAK
  • 3:15PM - 4:45PM (GMT Standard Time)

    Session 4

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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