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IMPACT OF ICH E2C (R2) AND GVP MODULE VII
Session Chair(s)
Michael Richardson, MD, FFPM, FRCP
Senior Vice President, WorldWide Patient Safety
Bristol-Myers Squibb, United Kingdom
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.
Speaker(s)
Implications of the PBRER for industry
Michael Richardson, MD, FFPM, FRCP
Bristol-Myers Squibb, United Kingdom
Senior Vice President, WorldWide Patient Safety
Challenges in the Management of the PSURs world
Wendy Huisman, PharmD
Vigifit, Netherlands
Director
Is the “Modular Principle” Working for New PSURs
Jan Petracek, MD, MSc
Ivigee, Czech Republic
CEO
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