Module 6

03/10/2024

Importance of maintaining the RSI (CDS, SmPC/PILs)

Mission of governance boards in the management of safety signals and communication of risks

Independence, Transparency & Consistency

Implementation

Evaluation

Decision making

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Core Data Sheet (CDS) or Basic Prescribing Information

⚫ The minimum essential information that must be included in the PI for every country where a product is marketed.

⚫ Produced by all MAHs for each of their marketed products.

⚫ CCSI: Company Core Safety Information is the minimum safety content required. Mueller, M., Lewis, D.J., Darisi, V.K.K., et al. Current Challenges in Labelling for Generic Medicinal Products: Company Core Data Sheet (CCDS) Development and Maintenance. Pharm Med December 2020 https://doi.org/10.1007/s40290-020-00364-7

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