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:
- MedDRA coding
- Signal detection and evaluation
- Clinical development
- Safety databases
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
- 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
Registration and Agenda:
Kuechengasse 16, Postfach
4002 Basel, Switzerland
Phone: +41 61 225 51 51
Fax: +41 61 225 51 52
Hotel & Travel
Attendees have to make their own reservation. Recommended hotel close to the EMA:
Hilton London Docklands Riverside
265 Rotherhithe Street,
London , SE16 5HW,
Telephone: +44 (0)20 7231 1001
Fax: +44 (0)20 7231 0599
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).
The training course takes place at the
European Medicines Agency (EMA)
7 Westferry Circus
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.