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NEW: Training Session on EU Batch Release for Immunological Veterinary Medicinal Products (IVMPs)

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European network of OMCLs
Immunological Veterinary Medicinal Products (OCABR/OBPR)
Training
29 October 2019 to 30 October 2019
Strasbourg, France

Introduction

Official batch release of Immunological Veterinary Medicinal Products (IVMPs) via Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR) is stipulated in the EU legislation for veterinary medicines. It is an important part of the regulatory framework in the EU/EEA that ensures that good quality IVMPs are available on the market.

OCABR and OBPR involve the independent control of each batch of an IVMP after it has been released by the manufacturer but before it is released onto the market. Competent authorities, Official Medicines Control Laboratories (OMCLs) and manufacturers of IVMPs are all involved in making sure this system runs smoothly.

See also

Programme Overview

This training will take a closer look at the principles and procedures used for application of OCABR and OBPR of IVMPs in the EU/EEA and in Switzerland, a mutual recognition partner.

The programme covers:

  • Regulatory requirements for IVMPs in the EU
  • An overview of Ph. Eur. monographs for IVMPs
  • An overview of the OCABR/OBPR procedures and guidelines for IVMPs
  • OCABR and OBPR from the perspective of the CA/OMCL
  • OCABR/OBPR from the perspective of the manufacturer
  • Tools for ensuring quality in the performance of OCABR and OBPR

The first day of the training session is open to participants from regulatory authorities and industry and will provide a sound overview of the important elements. It will include presentations from representatives of competent authorities, OMCLs and industry. A closed session is planned on the second day for regulatory authorities only and will include a practical hands-on session on OBPR.

Draft programme (subject to change)

 

Who should attend?

This training should be attended by persons involved in the official batch release procedures for IVMPs. The target audience is primarily staff from the authorities and industry who are new to the OCABR and OBPR systems.  While the main focus will be on batch release in the EU, participants from outside the EU/EEA and Switzerland are also welcome.

 

 

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