Webinar: Switzerland and the EU - The Differences in GMP and GDP

Webinar: Switzerland and the EU - The Differences in GMP and GDP

Course No 18132

Important: Deadline is 12.00 h CEST on 14 July 2020

Costs

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Christian Schmidt, gempex

Background

According to Annex 1, letters c and d, of the Medicinal Products Licensing Ordinance (MPLO), most parts of EU-GMP is valid in Switzerland. What might sound easy is not always the case. Not all of the current EU-GMP guidance is listed and sometimes it is not possible to implement updates in a timely manner.

In individual cases, there are also divergent requirements or different interpretations by the authorities.

Target Group

This Webinar has been designed for QA/GMP personnel and management functions who would like to get a comprehensive overview on the differences between Suisse and EU GMP/GDP.

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

Learn and discuss the following topics:
  • The Role of SwissMedic and the local inspectorates
  • Specific differences and how to deal with them
  • RP and QP
  • Implementation of new EU Guidance documents in Switzerland
  • The Mutual Recognition Agreement (MRA) : facilitation and constraints

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