Investigational Medicinal Product Dossier 2016-2025 Form
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Because the world ditches in-office work, the execution of documents more and more occurs electronically. The investigational medicinal product dossier form isn’t an exception. Handling it utilizing digital tools differs from doing so in the physical world.
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People also ask
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What is the difference between IMPD and IB?
IMPDs work in conjunction with other important documents: Investigator's Brochure (IB): While the IMPD and IB share some information, the IB provides more detailed guidance for trial physicians. Clinical Trial Application (CTA): The IMPD is a key component of the CTA, which is the main regulatory submission package.
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What is an investigational medicinal product dossier?
An Investigational Medicinal Product Dossier (IMPD) contains data on the quality, production and control of the medicinal product being researched.
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What is the difference between IMPD and sIMPD?
IMPD - This gives information on the quality of any IMP (including placebo), including summaries of information related to the quality, manufacture and control of the IMP. sIMPD - A simplified version of the IMPD. The Sponsor and/or Manufacturer will provide guidance as to whether an IMPD or sIMPD is required.
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What is the difference between CTA and IMPD?
An IMPD is one of the essential documents that form the CTA submitted to the EU Competent Authorities (CAs) for non-authorized IMPs. Where the IMP is subject of a marketing authorization, the Summary of Product Characteristics, complemented by additional data as necessary, could be submitted in lieu of the IMPD.
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