CRED SMPC 2024

17/09/2024

CRED Writing Effective Product Information

CRED Overview of Product Information – 25 September 2024

Implementation of Label and Leaflet: Industry Perspective

Betti Mozes-Stoddart, Sr. Manager, Global Product Labelling Operations Jazz Pharmaceuticals

The Organisation for Professionals in Regulatory Affairs

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Welcome and Introductions

Betti Mozes-Stoddart, Senior Manager, Global Product Labelling Operations

⚫ 17 years of experience in pharmaceutical regulatory affairs, gained at the European Medicines Agency, ICON plc and Jazz Pharmaceuticals

⚫ Specific expertise in the EU centralised procedure including regulatory requirements, management of the product information translations and the EMA linguistic review, artworks, blue box requirements and labelling exemptions

⚫ Current role: Labelling Operations Lead for neurology and oncology products in the EU and international markets, ensuring timely and compliant implementation of labelling materials

The views and opinions expressed in this presentation are those of the author and do not represent the official policy or position of Jazz Pharmaceuticals.

The Organisation for Professionals in Regulatory Affairs

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