Pharmacopeial compliance and marketing authorisations in Europe Masterclass - EU edition

In this training course, you will learn how to deal with the requirements of individual and general monographs and how to apply general chapters. In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on the implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question-and-answer sessions.

17-18 June, 2024, Virtual
Time Zone: UTC/GMT+1 /CET

Overview

To protect public health and ensure the availability of high-quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU. The European system offers different routes for such an authorisation, but there is only one set of common rule. Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorisation route for a medicine. This seminar provides the relevant know-how on the authorisation of medicinal products in Europe. You will learn which authorisation routes are possible and which documents you need for authorisation. The special features of the authorisation of active substances are also covered. You will also learn about the special features of the authorisation of active substances and the prominent role of the European Pharmacopoeia in ensuring the quality of medicinal products.

Pharmacopoeias play a major role in laying down quality standards for the manufacture and control of medicines in Europe and worldwide. These quality standards mostly cover active pharmaceutical ingredients and excipients both, in their original state and in the form of pharmaceutical preparations.

In this training course you will learn how to deal with requirements of individual and general monographs and how to apply general chapters. In this context, particular attention is paid to the revised, harmonized chapter on chromatography and the new chapter on implementation of pharmacopoeial procedures and you will learn how to apply these important texts in workshops and question and answer sessions.

Detailed information will be provided on impurity control, including nitrosamines and elemental impurities.

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RECOMMENDATION

Who should attend?

• Quality control managers
• Quality assurance managers
• Inspectors
• Regulatory affairs
• CMC managers
• Marketing authorisation