EDQM Training Module 1: General Methods, General Chapters & General Monographs

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINAR 28/06/2021

This module starts with a walk-through of the structure of the Ph. Eur. and explains the scope and correct use of General Monographs and Dosage Form Monographs as well as General Chapters.

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EDQM Training Module 2: Individual Monographs

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINAR 29/06/2021

Focus on chemically defined active substances and medicinal products.

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EDQM Training Module 3: Impurity Control in the Ph. Eur.

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINAR 01/07/2021

Learn more about the Ph. Eur. policy on impurity control.

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EDQM Training Module 4: Ph. Eur. Reference Standards

REFERENCE STANDARDS ON-DEMAND WEBINAR 02/07/2021

Learn about chemical reference standards used in conjunction with Ph. Eur. monographs and general chapters.

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EDQM Training Module 5: Fundamentals of the CEP Procedure

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINAR 05/07/2021

The background and scope of the CEP procedure is explained, as well as details on how to read a CEP and use it in a MAA application.

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EDQM Training Module 6: Building successful CEP dossiers

CERTIFICATION OF SUITABILITY ON-DEMAND WEBINAR 06/07/2021

This module is intended to help applicants to improve the quality of their dossiers. It also explains the basic principles for preparing a revision application.

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EDQM Training Module 7: Control of impurities: CEP approach

CERTIFICATION OF SUITABILITY ON-DEMAND WEBINAR 08/07/2021

This module covers in detail how to control impurities in active substances in the context of a CEP application.

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EDQM Training Module 8: The EDQM Inspection Programme

Certification of suitability On-demand webinar 09/07/2021

This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up.

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On-Demand Webinars

 Suggested Viewing/Reading

The EDQM recommends participants watch and read the pre-training materials listed below before joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the webinar sessions.

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