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Nonintervention postauthorisation safety studies: definition, obligations and requirementsPresented by: Annalisa Rubin, PhD Pharmacovigilance and Risk Management Sectoral agency of the European UnionPostauthorisation

How to fill out non-interventional post-authorisation

How to fill out non-interventional post-authorisation

1. Collect all relevant information and documents related to the post-authorisation study.
2. Clearly define the objectives, research question, and endpoints of the study.
3. Determine the study design, inclusion and exclusion criteria, and sample size.
4. Develop a study protocol that outlines the study methodology, data collection procedures, and analysis plan.
5. Obtain ethical approval from relevant authorities and ensure compliance with regulatory requirements.
6. Recruit eligible participants for the study based on the defined criteria.
7. Collect data using appropriate data collection methods and tools.
8. Ensure data quality and integrity through regular monitoring and validation.
9. Analyze the collected data using suitable statistical methods.
10. Interpret the results and draw conclusions based on the study objectives.
11. Prepare a comprehensive report that includes all the relevant findings and recommendations.
12. Submit the report to the appropriate regulatory bodies or stakeholders.

Who needs non-interventional post-authorisation?

1. Non-interventional post-authorisation studies are typically needed by regulatory authorities, pharmaceutical companies, and healthcare professionals.
2. Regulatory authorities may require these studies to evaluate the safety and effectiveness of a drug or medical intervention in real-world settings.
3. Pharmaceutical companies may conduct these studies to comply with post-marketing requirements and gather additional data on the product's performance.
4. Healthcare professionals may be interested in these studies to guide clinical decision-making and improve patient outcomes.
5. Overall, anyone involved in the evaluation, monitoring, or use of a drug or medical intervention may benefit from non-interventional post-authorisation studies.

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What is non-interventional post-authorisation?

Non-interventional post-authorisation refers to studies conducted after a medicine has been authorized for marketing, but which do not interfere with the prescribed use of the medicine in the daily clinical practice.

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

Marketing authorization holders are typically required to file non-interventional post-authorisation studies.

How to fill out non-interventional post-authorisation?

Non-interventional post-authorisation studies are filled out by following the guidelines set forth by regulatory authorities, typically involving submitting a protocol for the study.

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

The purpose of non-interventional post-authorisation studies is to gather additional real-world data on the safety and effectiveness of a medicine in routine clinical practice.

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

Information to be reported on non-interventional post-authorisation studies typically includes study design, objectives, outcomes, and data collection methods.