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Bethesda North Marriott Hotel and Conference Center

Apr 09, 2014 7:00 AM - Apr 10, 2014 5:45 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Global Labeling 2014: Compliance in a Changing Regulatory Environment

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Session 1 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Understanding the Issues

Session Chair(s)

Barbara Lachmann, MD

Barbara Lachmann, MD

Sole Proprietor

Barbara Lachmann Labeling Consulting, Germany

This session will provide an overview of the potential impact of the EU Good Pharmacovigilance Practice Guidelines on Core Labeling processes and elucidate EU regulatory authority expectations of a company's safety labeling performance.

Speaker(s)

Ralf Zerban, DrMed

Labeling-relevant Provisions in the EU's Good Pharmacovigilance Practice Guidelines

Ralf Zerban, DrMed

Vigiserv GmbH, Germany

Managing Director

Anna Toth, PharmD, MSc

An EU Inspector's Approach to Reviewing a Company's Safety Labeling Performance

Anna Toth, PharmD, MSc

Medical Products Agency, Sweden

Pharmacovigilance Inspector, Drug Inspectorate Industry & Hospital

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