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Post Authorization Safety Study (PASS) Information
Acronym / TitleURANIS Data collection in urological centers during
treatment with Ra223 dichloride (Fight) within the
framework of a nonintervention
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How to fill out post authorization safety study

How to fill out post authorization safety study
01
Ensure all relevant information is collected and documented
02
Follow specific instructions provided by the regulatory authorities
03
Compile all necessary data regarding the safety and effectiveness of the drug
04
Submit the completed form to the appropriate regulatory body for review
Who needs post authorization safety study?
01
Pharmaceutical companies seeking to ensure the safety and efficacy of their products post-authorization
02
Regulatory authorities looking to monitor the safety of approved drugs and medical devices
03
Healthcare providers and researchers interested in evaluating the real-world effects of a drug or medical device
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What is post authorization safety study?
A post authorization safety study is a research study conducted after a drug or therapy has been approved for marketing to assess its safety in a broader population.
Who is required to file post authorization safety study?
The sponsor of the drug or therapy, which is usually the pharmaceutical company that developed the product, is required to file the post authorization safety study.
How to fill out post authorization safety study?
Filling out a post authorization safety study typically involves collecting data on adverse effects, demographic information, and other relevant patient safety information, then submitting it through the appropriate regulatory agency's designated platform.
What is the purpose of post authorization safety study?
The purpose of a post authorization safety study is to monitor the long-term safety and effectiveness of a drug once it is in use by the general population, identifying any rare or unexpected side effects.
What information must be reported on post authorization safety study?
Information that must be reported includes adverse event reports, demographic data of study participants, results of any additional safety analyses, and comparisons to pre-authorization data.
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