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Xx I4VMCB023 Nonintervention PASS Final Study Reports Information Page 1 Due to the size, this document has been divided into 6 parts, all of which are available on the Except EU PAS register. Part

How to fill out non-interventional post-authorisation safety studies

How to fill out non-interventional post-authorisation safety studies

1. Identify the specific objectives of the non-interventional post-authorisation safety study.
2. Define the study population and inclusion/exclusion criteria.
3. Develop a study protocol outlining the study design, data collection methods, and analysis plan.
4. Obtain necessary approvals from ethics committees and regulatory authorities.
5. Recruit participants and collect relevant data as per the study protocol.
6. Analyze the data collected and interpret the findings.
7. Prepare a final study report summarizing the results and conclusions.
8. Submit the report to the relevant authorities for review and dissemination.
9. Monitor and evaluate the safety profile of the drug/product post-authorization.

Who needs non-interventional post-authorisation safety studies?

1. Pharmaceutical companies conducting post-market surveillance of their products.
2. Regulatory authorities requiring additional safety data for certain drugs/products.
3. Healthcare providers and researchers interested in evaluating real-world safety data.

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What is non-interventional post-authorisation safety studies?

Non-interventional post-authorisation safety studies are research studies conducted after a drug has been authorized for use. These studies monitor the safety and effectiveness of the drug in a real-world population, focusing on its utilization and possible adverse effects.

Who is required to file non-interventional post-authorisation safety studies?

Manufacturers or marketing authorization holders of pharmaceutical products are typically required to file non-interventional post-authorisation safety studies, as part of their obligations to ensure ongoing safety monitoring.

How to fill out non-interventional post-authorisation safety studies?

To fill out non-interventional post-authorisation safety studies, one needs to provide a detailed protocol that includes study objectives, design, methodology, data collection methods, and expected outcomes. It should also comply with regulatory guidelines and procedures mandated by health authorities.

What is the purpose of non-interventional post-authorisation safety studies?

The purpose of non-interventional post-authorisation safety studies is to gather additional data on the safety profile, effectiveness, and usage patterns of a drug in a broader, real-world population, which may not have been fully captured during pre-market clinical trials.

What information must be reported on non-interventional post-authorisation safety studies?

The information that must be reported includes study design, outcomes, adverse event reports, data on patient population, analysis of the results, and any other relevant findings that contribute to the understanding of the drug's safety and effectiveness.