The general chapters and monographs in the European Pharmacopeia revisited (10561)

The general chapters and general monographs in the European Pharmacopeia provide a framework, which is legally binding in 39 member states. Important general chapters and general monographs underwent recently major revision, new general monographs have been added. In January 2023 the 11. Edition of the European Pharmacopoeia became official. A good opportunity to revisit these chapters and monographs and to explore changes and added requirements with impact to pharmaceutical quality control and stability testing.

Topics covered:

• Revised chapter 1 "General Notices"
• New chapter 2.1.7 "Balances for analytical purposes"
• Revised (and harmonised) chapter 2.2.46 "Chromatographic separation techniques"
• New general method chapters
• New general method 2.4.36 "N-Nitrosamines in active substances"
• General methods with minor revisions
• New general chapter 5.26 "Implementation of pharmacopeial procedures"
• New general chapter 5.27 "Comparability testing of alternative methods"
• Revision of the general monograph "Substances for pharmaceutical use"
• Revision of the general monograph "Pharmaceutical preparations"
• Changes in the certification procedure (submission, revision and renewal of CEPs)
• New edition of the Technical Guide for the elaboration of Ph. Eur. monographs
• Flexibility in the Ph. Eur. - Really?! a paradigm shift

Duration in total approx. 3 hours
Lecture language: English | Slides: English

Your speaker: Prof. Dr. Markus Veit is the managing director of ALPHATOPICS GmbH. He studied pharmacy in Frankfurt, obtained his doctorate at the Julius-Maximilians-University in Würzburg and was assistant professor there in the Department of Pharmaceutical Biology. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharmaceutical development, testing and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry. He is an expert for herbal medicinal products and was involved in numerous applications for marketing authorisations of herbal medicines in Europe and rest of the world. In the past years he is increasingly involved in projects related to medicinal and other cannabis products.

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