This module opens with a walk-through of the structure of the Ph. Eur., recalling the general underlying concepts, including the General Notices. The scope and correct use of general monographs, dosage form monographs and general chapters are 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 CEP Procedure, such as recent graduates or early-career professionals.

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Duration: 1 hour, 30 minutes

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• General Methods, General Chapters & General Monographs by Bruno Spieldenner

Other Events / Training Sessions  

• Module 2: Individual Monographs - Focus on chemically defined active substances and medicinal products
• Module 3: Impurity Control in the Ph. Eur.