Workshops on how to work with and use the Medical Dictionary for Regulatory Activities (MedDRA) in pharmacovigilance
The Agency for Medicinal Products and Medical Devices, in collaboration with the Maintenance and Support Services Organization for MedDRA (MSSO) organises in February 2010 two workshops in the use of the Medical Dictionary for Regulatory Activities (MedDRA).
The workshops are intended for pharmacovigilance officials of the Agency for Medicinal Products and Medical Devices, Marketing Authorisation Holders and Clinical Trial Sponsors.
The first (1st) workshop, "Coding with MedDRA", providing the basics of coding with MedDRA, will be held on 8 February 2010 (Monday).
- Basic workshop for all participants encountering MedDRA coded data in their pharmacovigilance activities.
- This one-day workshop provides an introduction to the basics, structure and features of the Medical Dictionary (MedDRA), presenting certain terms from MedDRA application and the method of their use in the coding of clinical data. It is designed for individuals using MedDRA to code clinical data and for those using MedDRA coded data in their daily work. During the workshop, the participants will be individually solving tasks aided by a computer (practical tasks of coding clinical data in adverse reaction reports).
- The participants will receive an attendance certificate.
The second (2nd) workshop, "MedDRA Safety Data Analysis and SMQs", will be held on 9 February 2010 (Tuesday).
- Advanced workshop for the participants who have completed the basic "Coding with MedDRA" course and are engaged in the MedDRA coded pharmacovigilance data analysis.
- The workshop is focused on the data stored in MedDRA. The participants will be given several real-life examples of the MedDRA coded pharmacovigilance data analysis, and the use of the Standardised MedDRA Queries (SMQs) in medicine safety signal detection.
- The participants will receive an attendance certificate.
Both courses will be lead by Dr Philippe Thouvay.
Venue and address of the workshops: Infodom d.o.o., A. Žaje 61/1, Zagreb.
Duration of the workshops: from 9.00 a.m. until 5.00 p.m. with a lunch break from 12.00 a.m. until 12.30 p.m.
Working language of the workshops will be English.
The maximum number of participants is 15 per workshop. No attendance fee will be charged.
In view of the limited number of participants, interested parties should contact Ms Viola Macolić Šarinić at viola.macolic@almp.hr or call her on (01) 48 84 330 no later than 18 January 2010. Acceptance will continue until full capacity is reached.
If a participant is unable to attend he/she must cancel his/her registration no later than by 3 February 2010 for the "Coding with MedDRA" workshop, and no later than by 4 February 2010 for the "MedDRA Safety Data Analysis and SMQs" workshop, using the above contact information.
