Global Labelling and Company Core Datasheet (CCDS) - Enhancing efficiency and compliance in global labelling
Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.
- The CCDS - central element in the labelling process
- CCDS in product development and throughout
the product life cycle
- Content and structure of the CCDS
- Implementation of CCDS changes in global/local product information
- Case studies and regulatory requirements from relevant markets
| Veranstaltungs-Code | FB24-516852-61077288 |
Bildungsziel der Schulung:
The Company Core Data Sheet (CCDS) serves as the central reference for all information related to a medicinal product. Any errors made here-whether in content or execution-can impact package inserts worldwide, ultimately affecting the perception and use of the product. Therefore, the CCDS should not be considered in isolation but rather as part of an intricate system, involving close collaboration between all central departments.
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In this seminar, you will gain a comprehensive understanding of the CCDS concept and the requirements for global labelling. We will delve into the interrelations between the CCDS, pharmacovigilance, regulatory affairs database systems, and the role of the Qualified Person for Pharmacovigilance (QPPV).
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The afternoon workshop, featuring case studies, will provide practical insights into market-specific requirements (with a focus on the EU and USA), regional labelling considerations, and their influence on the CCDS.
Veranstaltungsort:
Online-Webinar
weitere Orte/Termine
Kursart:
Online-Webinar
Kostenlos Info anfordern
