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, the link between individual and general monographs and general chapters, and the structure of monographs on active pharmaceutical ingredients (APIs), excipients and medicinal products containing chemically defined active substances. It describes the different sections of individual monographs with a focus on the policy for medicinal product monographs (including titles and the dissolution test). The recording includes a Q&A session.
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Target audience
The module is of interest to all individuals involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.
It is ideal for anyone looking to build a solid foundation knowledge of both the Ph. Eur. and the CEP Procedure, such as recent graduates or early-career professionals.
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Duration: 1 hour, 30 minutes
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