Berlin: Outsourcing from API to Drug Product - (GMP and regulatory Perspective in EU and US)

This course will focus on individuals that have input into supply chain management decisions, or who have oversight or actively manage technology transfers in EU or US. Particularly, Dr. Hiltrud Horn will give detailed insight into outsourcing strategies for EU and US, from both perspectives, QC and QA. Furthermore she will guide you through the process transfer of drug substances and drug product. In a specifically tailored workshop she will show you the essentials of the project management for a typical technology transfer project. Upon completion of this workshop you will be able to set up your supply chain successfully, understand the essential principles for starting outsourcing activities and know the necessary GMP and regulatory background.

For more information please visit the following website:

(Conference organized by PDA )



Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528


  • 19.03.2020
    Frankfurt: Nitrosamine Impurities
  • 21.-22.04.2020
    Heidelberg: Handling Changes and Variations
  • 05.05.2020
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
Get all events


  • 10.03.2017
    News for the Industry
  • 26.07.2013
    News on Change Control/Variations:
  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
Get all news
EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
This website uses cookies. By using the website you agree to the use of cookies. Privacy Policy X