Council for europe portal
Language : en Search
Choose language

NEW: Training on the ‘Management of Extraneous Agents in IVMPs

Back
European Pharmacopoeia
Medicine for veterinary use
Training
01 April 2020 to 02 April 2020
Strasbourg, France

 

Introduction

The approach to extraneous agent testing in immunological veterinary medicinal products (IVMPs) has recently been updated and manufacturers of these products are required to comply with the revised text from 1 July 2020.

With the new and more flexible approach, methods are no longer described in detail and users can tailor the tests to individual product needs. From starting material to finished product, users will have to follow an overall risk-management approach to ensure that the best testing strategies are selected to provide a consistent manufacturing process and thus ensure the quality of the product.

This new approach will also enable the use of state-of-the-art testing methods and is expected to increase the development of more robust in vitro methods and reduce the use of in vivo testing.

 

Programme Overview

The main programme topics include:

  • A summary of revised European Pharmacopoeia requirements for extraneous agent testing, what has changed and why, with a particular focus on risk management; this will be accompanied by concrete examples on how to apply the new approach.
  • In a second session, the floor will be given to vaccine manufacturers, large and small, to share their experience with the new approach and discuss outstanding questions/concerns.
  • The third session will be dedicated to the European regulatory landscape. The audience will have the opportunity to learn about the latest developments in the elaboration of guidance and Question & Answer documents aimed at facilitating the application of the new approach.
  • The last session will take a look at the future, including modern molecular technologies.
  • Ample time has been scheduled for question and answer sessions.

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. The aim is to help users of the Ph. Eur. to be ready to use the new approach by the implementation date of 1 July 2020.

 

Who should attend?

This training will be of interest to vaccine manufacturers, representatives from national and international regulatory bodies, and staff members and scientists involved in the quality control and, in particular, the extraneous agent testing of IVMPs, be it in R&D, manufacturing, regulatory affairs, quality assurance or similar functions in both industry and regulatory authorities, or sub-contracting laboratories.

 

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

twitter facebook googleplus pinterest linkedin email