ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS

Track:
eTools and Data Management

Day & Time:
March 6, 11:00AM - 12:30PM

Session Number:
0806

Room Number:
G102

Type:
Session

Title:
ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS

Chair(s):
Anki Hagstroem, MSc
Section Manager
Uppsala Monitoring Centre, Sweden

Description:
Recent years have seen significant progress towards international harmonization in data transfer formats for safety information. The new ICSR message format E2B(R3) requires structured medicinal product information as described in the family of Identification of Medicinal Products (IDMP) standards, which will have a large impact on the industry. While the European Medicines Agency have taken concrete steps towards IDMP in the implementation of the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD), the future is sketchier for the remaining ICH regions, which will all have regional variations. This session will cover what is included in IDMP and how it relates to XEVMPD, practical implications and roadmaps thereof. In addition, it will outline the challenges of operating in a global regulatory landscape that goes far beyond the ICH countries, with a case study of incorporating ICSRs from the Chinese National Center for ADR Monitoring into the VigiBase™ database.

Presentation(s) & Speaker(s):
ICSRs monitoring in global PV, Communication in the evolving PV community
Madeleine Krieg, RPh
Product manager
The Uppsala Monitoring Centre, Sweden

The impacts and challenges of XEVMPD and its future in IDMP
Jo English
Director of Regulatory Implementation Consulting
Liquent, United Kingdom

EVMPD is done, long live IDMP!
Wim Cypers, MPharm
VP, Regulatory SPU
ArisGlobal, Belgium