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:
- Coding of ICSRs
- Signal detection and evaluation
- Clinical development
- Safety databases
Sabine Brosch, PharmD, PhD • Principal Scientific Administrator, Monitoring and Incident Management, PhV European Medicines Agency, United Kingdom
Mick Foy • Group Manager, Vigilance Intelligence and Research Group MHRA, United Kingdom
Patrick Revelle • Director, MedDRA MSSO MedDRA MSSO, United States
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
Karin Gamba-Blessing, Event Manager
Phone: +41 61 225 51 61
Fax: +41 61 225 51 52