CRED Understanding Clinical Development 2024

09/10/2024

Risk Management Plan (RMP)

● Safety specification •

Important identified risks

• •

Important Potential risks

Missing information

● Pharmacovigilance plan • focus on practices and action plans exploring specific safety concerns based on specifications. • Routine and additional PV activities • Studies the company will undertake to determine more fully the safety profile when the drug is marketed • PASS

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Post Authorisation Safety Studies (PASS) A study performed in the post-marketing period with the main aim of investigating safety of the product in the indication for which the product has been approved

Interventional

•

•

Performed as a GCP clinical trial

• Non-interventional (epidemiological)

• Performed with marketed product prescribed in normal clinical practice

• Relevant guidance's are good pharmacoepidemiological practice (NOT GCP)

• Prospective collection of data (primary data collection)

• Retrospective use of data already available in health care databases or patient notes (retrospective data collection)

• Regulatory guidance in module VIII of GVP

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