CRED Understanding Clinical Development 2024

09/10/2024

Company Core Safety Information (CCSI)

Format and content of Product Information (label) are different in different geographies and regulators reach different conclusions regarding the safety profile of a product

CCSI

Safety information that the company believes should be included in all labels and therefore submitted for approval by local regulators

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Risk management

• Review and documentation of risks throughout drug development

• Always in the context of benefits of the drug to the patient

• Document risks (usually from FTIH)

• The Risk Management Plan (RMP) is a dynamic document that the company will update throughout the lifecycle of its product. It includes additional safety concerns where required and removal or reclassification of safety concerns as the medicine’s safety profile is further characterized.

• Evolves into RMPs for marketing authorisation applications

• DSUR, IB and protocols also lists risks

The Organisation for Professionals in Regulatory Affairs

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