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NEW: European Pharmacopoeia training session on biologicals

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European Pharmacopoeia
Biologicals
Training
04 February 2020 to 05 February 2020
Strasbourg, France

Introduction

As public quality standards, the European Pharmacopoeia (Ph. Eur.) monographs play an essential role in ensuring the quality of medicines and substances for pharmaceutical use.

They are designed to meet the needs of stakeholders, including regulatory authorities (such as OMCLs, assessors) and manufacturers.

 

 

 

Programme Overview

The training session will cover the work and procedures of the European Pharmacopoeia in detail, illustrate the concept of monographs and general chapters for biologicals, and provide some insight into the evolution of thinking and the latest trends in the field.

This training session presents a key opportunity to:

  • learn more about the place and role of the EDQM and the Ph. Eur. in the European regulatory framework;
  • obtain practical advice on the proper use and interpretation of the Ph. Eur. texts relevant to biologicals (including general considerations on the 3Rs, microbiology chapters and testing for bacterial endotoxins);
  • gather information on current hot topics (for example, biotherapeutic products, including monoclonal antibodies and vaccines for human use) and what is expected for the future;
  • get an overview of the role and proper use of Ph. Eur. reference standards and of the process used to establish them.

Participants will have the opportunity to interact directly with specialists in the field, discuss specific technicalities based on case studies and share practical experience using concrete examples.

Preliminary Programme (available soon)

 

Who should attend?

This training course will be of interest to staff members of national regulatory bodies and scientists involved in the development, manufacturing, quality control, quality assurance and licensing of medicinal products. It is ideal for new and junior staff members wanting to familiarise themselves with the field of biologicals.

 

Send us your questions in advance
If you would like to submit a question in advance of the training session, please complete the Question form and send it to the Public Relations Division.

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