Individual monographs are the core texts of the Ph. Eur., covering active substances, excipients and also medicinal products. This module provides an overview of the general principles, explains the link between individual and general monographs and general chapters, and the structure of monographs on APIs, excipients and medicinal products containing chemically defined active substances. It describes the different sections of individual monographs with a focus on the new policy for medicinal product monographs (including titles and the dissolution test). The recording includes a Q&A session.
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This module is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.
Duration: 1 hour, 30 minutes
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- Individual monographs on “Substances for pharmaceutical use” and on Medicinal Products (containing chemically defined APIs) by Sylvina Iossiphova and Amela Saračević
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