Webinar The new Annex 21

Webinar The new Annex 21

Course No 17905


Costs

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Speakers

Dr Ulrich Kissel, Chairman of the Board of Directors of the European QP Association (EQPA)

Background

In February, after some delays, the new Annex 21 to the EU GMP Guideline was published as a draft. The document is entitled
“Importation of medicinal Products”.

The Guidance is aimed at Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries. The following points should be regulated:
  • Physical transfer from a third country to the EU/EEA
  • Certification by a Qualified Person
  • Requirements for facilities and equipment
  • Documentation needed
  • GMP requirements for manufacturers and exporters in the third country
  • Qualification and audits under the responsibility of the importing company
  • Import testing
  • Contractual regulations

Target Group

Manufacturing and Importation Authorisation holders (MIA holders) who import human or veterinary medicinal products from third countries.
 

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

This webinar will give you an overview of the most important points of the new appendix:
  • What is really new and not yet addressed in any other guidance
  • Are there contradictions to other documents?
  • What needs to be considered?
  • What is important for QPs?

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