MSSO Regulatory Authority MedDRA Training

The MedDRA MSSO coordinates with regulatory authorities within the ICH regions to conduct free MedDRA training courses. To request training within the ICH regions, please contact the MSSO Help Desk (mssohelp@mssotools.com).

Training can also be supported beyond the ICH regions by sending a training request to the ICH Secretariat (admin@ich.org). The request will be coordinated with the ICH Global Cooperation Group (GCG).

Who is eligible?
Any drug or device regulatory agency that subscribes to MedDRA.

What is offered?
Coding with MedDRA
MedDRA: Safety Data Analysis and SMQs

What are the costs?
There is no cost for the training course. Attendees are responsible for their travel costs.

Session Information

The MSSO regularly holds training classes with the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and Health Canada. If you are interested in MedDRA free training sessions for these authorities, please contact your regulatory agency's Point of Contact:

European Medicines Agency (EMA)
Aniello Santoro
aniello.santoro@ema.europa.eu
http://eudravigilance.ema.europa.eu/human/meddra02.asp

US Food and Drug Administration (FDA)
Contact the MSSO Help Desk

Health Canada Marketed Research Products
Alison Langevin
613.948.6337
alison.langevin@hc-sc.gc.ca

How do I register?
Contact the regulatory agency Point of Contact listed above for course schedule and registration.