This module starts with a walk-through of the structure of the Ph. Eur., opening with a reminder of the general underlying concepts, including the General Notices. The scope and correct use of General Monographs and Dosage Form Monographs as well as General Chapters is also explained. Finally, participants learn about new and revised general chapters and texts, relevant for chemically defined active substances, which have been recently updated or are on the work programme of the Ph. Eur. expert groups. The recording includes a Q&A session.
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Target audience
The 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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