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Safety Reporting Requirements for Marketing in the EU

About this episode

For US-based companies seeking to market their product in the EU, it can be a struggle to navigate a different market, and, in particular, to manage requirements from a safety reporting perspective. The podcast explores the challenges faced managing not only the European pharmacovigilance legislation but also dealing with each EU Member State, which can implement these requirements in their own way at the national level.

Monica Buchberger is senior director of pharmacovigilance at PharmaLex, drawing on her many years in industry in pharmacovigilance and regulatory roles, including quality assurance systems and serving as the EU QPPV for Abbott Laboratories.
Stephen Sun is a physician by training who heads up the US pharmacovigilance team for global PharmaLex and is also the service area head for benefit-risk management.