PHARMACOVIGILANCE AND MEDICINAL PRODUCT STANDARDS AND METADATA

Track:
eTools and Data Management

Day & Time:
March 5, 2:00PM - 3:30PM

Session Number:
0803

Room Number:
G105

Type:
Session

Title:
PHARMACOVIGILANCE AND MEDICINAL PRODUCT STANDARDS AND METADATA

Chair(s):
Andrew P. Marr, PhD
Managing Director
Marr Consultancy Ltd., United Kingdom

Description:
The initial requirement for submission of XEVMPD data by July 2012 has passed and now product records now need to be maintained. The session addresses the experiences, successes and challenges currently being encountered. Furthermore, as the interim XEVMPD standard move towards being replaced by the ISO IDMP standards in 2016 the issues associated with these changes are also addressed.

Presentation(s) & Speaker(s):
XEVMPD Experience to Date - The ongoing activities and the future towards IDMP
John W. Kiser, MSc
Senior Director, Regulatory Operations
Abbvie, United States

From XEVMPD to IDMP
Christian Kravogel, MS
Product Manager
EXTEDO GmbH, Germany

Transitioning to IDMP – Challenges and Opportunities
Andrew P. Marr, PhD
Managing Director
Marr Consultancy Ltd., United Kingdom