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:
- Coding of ICSRs
- Signal detection and evaluation
- Clinical development
- Safety databases
- 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
DIA Europe, Middle East and Africa
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
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
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
Tel.: +44 207 341 8000
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.