SmPC Essentials: A practical bridge between regulatory language and real-world scientific exchange
Aimed at young professionals in Medical Affairs, Regulatory Affairs, Market Access and related functions, this practical webinar will explore how the Summary of Product Characteristics (SmPC) is developed, maintained and used in practice.
The first part will explain how an SmPC is shaped, approved and updated, illustrated by a practical case study on a pediatric label extension.
The second part will focus on the use of the SmPC in real-world scientific exchange, including key do’s and don’ts, common interpretation pitfalls, on-label versus off-label discussions, and how to position the SmPC alongside other scientific data sources.
The webinar aims to help participants better understand the SmPC as both a regulatory document and a practical reference point in daily professional interactions.
Speakers:
- Carine Schadeck, PhaRaAssociate Director Scientific and Procedural Regulatory Affairs at PhaRA
- Wim Neckebroeck, Director of Regulatory Affairs at Kintiga