Individual monographs are the core texts of the Ph. Eur., covering active substances, excipients and also medicinal products. This module will provide 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 will describe the different sections of individual monographs with a focus on the policy for medicinal product monographs (including titles and the dissolution test).
The presentations will be followed by a live Q&A session.
Programme (subject to change):
10:00-10:30 Individual monographs on chemically defined active substances
10:30-11:00 Individual monographs on medicinal products containing chemically defined active substances
11:00-11:30 Live Q&A Session