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2024 EDQM Virtual Training Programme: 4 independent modules on European Pharmacopoeia texts related to Biologicals and on Microbiology chapters

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINARS 30/01/2024 - 01/02/2024

4 modules covering Biologicals and Microbiology Ph. Eur. Chapters as well as Ph. Eur. Reference standards for biologicals.

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Webinar on new general chapter Comparability of alternative analytical procedures (5.27)

European Pharmacopoeia On-demand webinar 17/01/2024

A new general chapter on Comparability of alternative analytical procedures (5.27) has been published in Supplement 11.5 of the European Pharmacopoeia (Ph. Eur.) in January 2024. While this text does not introduce any new requirements, it does provide valuable information on how users wishing to...

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Webinar on the new Ph. Eur. Cannabis flower monograph (3028)

European Pharmacopoeia On-demand webinar 14/12/2023

The new monograph Cannabis flower (3028) was adopted at the 176th session of the European Pharmacopoeia (Ph. Eur.) Commission in June 2023. It will be published in Ph. Eur. Supplement 11.5 and will become the legally binding standard in Europe for cannabis flower on 1 July 2024. In response to...

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Anti-D Immunoglobulin: Exploring collection, production and alternatives

Blood ON-DEMAND WEBINARS 11-25/09/2023

When a mother with RhD-negative blood is pregnant with a baby that has RhD-positive blood, there is a risk her immune system will create antibodies that go on to attack the red blood cells of her next RhD-positive baby. This is known as “Rhesus Disease”, which can have serious and potentially...

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Joint EDQM-USP Webinar on “Secondary standards - Considerations in traceability to pharmacopeial standards"

European Pharmacopoeia & Reference Standards On-demand webinar 10/10/2023

Information to help users reduce the risks and avoid pitfalls when using secondary standards.

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

EUROPEAN PHARMACOPOEIA ON-DEMAND WEBINAR 29/06/2023

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 30/06/2023

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 03/07/2023

This module gives a general presentation of the CEP procedure. The background and scope of the CEP procedure is explained in detail, and a comparison with the Active Substance Master File (ASMF) procedure is made. The second part of the module provides tools and tips on how to read a CEP and...

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EDQM Training Module 6: Building successful CEP dossiers

CERTIFICATION OF SUITABILITY ON-DEMAND WEBINAR 04/07/2023

The first part of this module explains how to build a good application for a new CEP and how to avoid deficiencies. The module is based on the top 10 most frequently asked questions after the initial evaluation of new CEP applications, along with expectations and recommendations on how to...

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EDQM Training Module 8: The EDQM Inspection Programme

Certification of suitability On-demand webinar 07/07/2023

This module provides information on how EDQM inspections for API manufacturers are organised, conducted and followed up. The participants receive information to facilitate efficient preparation for the inspection, in particular with regard to obligations/communications ahead of time. An...

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The CEP 2.0 – Webinar for CEP holders and CEP users

Certification of suitability (CEP) 11 and 16 May 2023 ON-DEMAND WEBINAR

In 2020, the European Directorate for the Quality of Medicines & HealthCare (EDQM) launched the “CEP of the future” project to design a “new-look” CEP to better meet the current needs of stakeholders, offer enhanced user-friendliness and provide greater information transparency. This project is...

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European Pharmacopoeia: specific chapters for herbal substances, herbal preparations and herbal medicinal products.

European Pharmacopoeia 27 April 2023 Training

This webinar is designed to provide participants with detailed knowledge and understanding of the relevant European Pharmacopoeia texts in the field of herbal medicinal products. It presents the general structure of the different general texts and general monographs and explains their...

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Joint EDQM-EPAA Event: The future of pyrogenicity testing: phasing out the rabbit pyrogen test

European Pharmacopoeia Conference / Training 14 to 16 February 2023

An international event on the future of pyrogenicity testing and an update on the scientific progress in the quest to deliver alternative and humane methods. Includes a training session on the MAT.
 

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Microbiological Risk of Contamination Assessment tool for tissues and cells. All you need to know about the MiRCA tool.

Organs, tissues and cells Training 19/01/2023

The procurement, processing, storage and distribution of human tissues and cells (TC) intended for human application must comply with the highest standards of quality and safety, aligned with the current regulatory framework and the latest evidence-based scientific requirements, in order to...

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