Definition of investigational medicinal product
The Health Products Regulatory Authority
Therefore, to classify a "medicinal product" as an "investigational medicinal product" a sponsor must consider both its intended use and the objectives of the study. For example, if it is to be used as the test substance or reference substance (active comparator or placebo) in …
[DOCX File]Individual Inspection Report Template
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Investigational medicinal product(s) Product(s) [N. ame & active ingredient]: Application. EMA reference number. Name and full address of the applicant. Clinical trial(s) [Add r. ... Definition. Conditions, practices or processes that would not be expected to adversely affect the rights, safety or wellbeing of the subjects and/or the quality ...
[DOCX File]Guide: Investigational medicinal product dossier for ATMP
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Introduction: Purpose and scope. In the absence of detailed guidance or a template for the content of the Investigational medicinal product dossier (IMPD) for Advanced therapy medicinal product (ATMP) quality, this document has been created as an authoring guide for first in human (FiH) and early clinical studies where the focus is on safety.
[DOCX File]Teletrial’s Primary Site Investigational Medicinal ...
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Transfer of Investigational Medicinal Product within a Teletrial Cluster. Transfer Criteria. As required to comply with the clinical trial protocol the Primary Site Pharmacy will transfer Investigational Medicinal Product (IMP) for dispensing/administration to satellite sites in the teletrial cluster.
[DOC File]RECORDING, MANAGEMENT AND REPORTING OF ADVERSE …
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with the information about the medicinal product in question set out. in the case of a licensed product, in the summary of product characteristics (SmPC) for that product. in the case of any other investigational medicinal product, in the Investigator’s Brochure (IB) relating to the trial in question. Regulatory Authority
[DOCX File]Purpose:
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Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more Investigational Medicinal Product(s), and/or to identify any adverse reactions to one or more Investigational Medicinal Product(s) and/or to study absorption, distribution, metabolism and excretion of one or more Investigational Medicinal Product(s) with the …
[DOC File]Annex
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The definition of an “investigational medicinal product” (IMP) is provided in Subsidiary legislation 458.43, as “a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the author…
[DOC File]New Chapter 8 of GMP guide for consultation
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In the case of an investigational medicinal product for which a marketing authorisation has been issued, the manufacturer of the investigational medicinal product should, in cooperation with the sponsor, inform the marketing authorisation holder of any quality defect …
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