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Introduction

The purpose of the Forum Europe 2017 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade. This Forum focuses on relevant CMC issues throughout the lifecycle of a product and thereby fosters collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices. The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe and will feature an opening regulatory session that will include presentations from EMA, ANSM, US FDA and other European regulatory health authorities. The technical sessions will include discussions on continuous process verification; combination trials and combination products; innovative approaches for tools and technology; and an overview of ICH Q12 with emphasis on approved matters/established conditions and post-approval change management protocol (PACMP).

Useful links

Venue

The Malton Hotel

The Malton Hotel, Town Centre, Co. Kerry, Killarney, V93 R866, Ireland

Contact information

Karen A. Bertani
Contact us by email

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