Webinar: GMP Update 2021/2022

Webinar: GMP Update 2021/2022

Course No 19311

Important: Deadline is 12 noon on 09 December 2021. All times mentioned are CET.

Costs

ECA-Member*: EUR 249,--
Non ECA Member*: EUR 299,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

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

Speakers

Dr Bernd Renger

Background

One might easily get the impression that the GMP world is continuously turning faster. Laws, regulations, and especially GMP requirements of the EU are constantly renewed, modernised and (allegedly) adapted against each other. The effects of the pandemic and the Brexit bring additional demands. To provide you with an overview is thus the goal of this webinar.

Target Group

The webinar targets executives and staff in the pharmaceutical industry, who want to get a compact but yet comprehensive overview of all recent changes in the GMP requirements.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/testmeeting. 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 aims at giving you a comprehensive but still compact overview about the many innovations in the GMP area – those already realised and those planned:
 
  • New developments in the EU
    - EU-GMP Guidelines and Annexes
    - Reflection Paper GMP and Marketing Authorisation Holders
    - Quality requirements for Investigational Medicinal Products
    (IMPs)
    - Regulation (EU) 2019/6 on Veterinary Medicinal Products
  • New WHO standards for pharmaceutical development and investigational medicinal products
  • Corona and its consequences:
    - Impact on inspections and approvals (EU and FDA)
  • Brexit and no end
  • News from PIC/S
  • Outlook for 2022

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