Safety Reporting Requirements For Marketing In The EU

Companies based in the United States aiming to introduce their products to the EU often encounter hurdles in adapting to a distinct market, particularly in handling safety reporting obligations. This podcast delves into the complexities of managing European pharmacovigilance legislation and the additional challenge of navigating individual requirements set by each EU Member State, which may implement regulations differently at the national level.

Speaker Bios: 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.