戻る Agenda
Session 1 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Understanding the Issues
Session Chair(s)
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)
Labeling-relevant Provisions in the EU's Good Pharmacovigilance Practice Guidelines
Ralf Zerban, DrMed
Vigiserv GmbH, Germany
Managing Director
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