IMPACT OF ICH E2C (R2) AND GVP MODULE VII

Track:
Pharmacovigilance

Day & Time:
March 6, 2:00PM - 3:30PM

Session Number:
0407

Room Number:
Elicium 2

Type:
Session

Title:
IMPACT OF ICH E2C (R2) AND GVP MODULE VII

Chair(s):
Michael Richardson, MD,FFPM
International Head GPV&E and EU QPPV
Bristol-Myers Squibb, United Kingdom

Description:
Periodic Safety Update Reports (PSURs) represent a large proportion of pharmacovigilance work for both industry and regulatory authorities. The dramatic shift from the limited focus of PSURs on post-authorisation safety to the comprehensive and critical report on continuous update of benefit/risk balance created uncertainties about ownership of the document, its use, teams that need to be involved, data to process, and impact of the report conclusions. Speakers will share their first practical experience with implementation of the new standards in the EU and globally.

Presentation(s) & Speaker(s):
Implications of the PBRER for industry
Michael Richardson, MD,FFPM
International Head GPV&E and EU QPPV
Bristol-Myers Squibb, United Kingdom

Challenges in the Management of the PSURs world
Wendy Huisman, PharmD
EU Qualified Person for Pharmacovigilance
Teva Pharmaceuticals Europe B.V., Netherlands

Is the “Modular Principle” Working for New PSURs
Jan Petracek, MD,MSc
CEO
European Pharminvent Services, Czech Republic