• Company
• Industries
• Consulting
• Project Management
• GXP
• Training
• Information

• Events 2024
• Events 2023
• Events 2022
• Events 2021
• Events 2020
• Events 2019
• Events 2018
• Events 2017
• Events 2016
• Events 2015
• Events 2014
• Events 2013
• Events 2012
• Events 2011
• Events 2010
• Events 2009
• Events 2008

Events 2014

• 18. - 19.02.2014
  Heidelberg: FDA-/GMP- gerechter Prozess-Transfer
  In this conference, Dr. Hiltrud Horn will give detailed insight into regulatory strategies for the transfer of drug products in EU and US. You will learn how to handle process transfers efficiently ... More
  
• 19.03.2014
  Frankfurt: Regulatorische Anforderungen an Primärpackmittel
  In this conference, Dr. Hiltrud Horn will give detailed insight in the regulatory aspects for primary packaging material. Furthermore Dr. Horn will present how to address the information on packaging ... More
  
• 03. - 04.04.2014
  Berlin: Handling Changes and Variations
  In this two days conference, Dr. Hiltrud Horn will give presentations on how to deal with manufacturing process changes and with packaging changes. Furthermore, detailed insight will be provided on ... More
  
• 13. - 14.05.2014
  Bonn: Der Regulatory Affairs Manager
  During this two days seminar, Dr. Hiltrud Horn will give detailed insight into the essentials of Regulatory Affairs. You will learn how to prepare the Quality part of the dossier and how to deal with ... More
  
• 17. - 18.06.2014
  Copenhagen: Change Control – New Aspects and Best Practices
  If you want to know how to handle changes in US and how to implement a comprehensive change control system within your company, then you should attend the “Change Control – New Aspects and Best ... More
  
• 24.06.2014
  Mannheim: FDA kompakt: Organisation, Systeme, Inspektion
  In this conference, Dr. Hiltrud Horn will give detailed insight into the essentials about regulatory requirements in US and preparation of dossiers in US (IND, NDA, DMF). Furthermore Dr. Horn will ... More
  
• 26.09.2014
  Frankfurt: Prozessvalidierung - neue Herausforderungen für Regulatory Affairs
  In this training course, Dr. Hiltrud Horn will give detailed insight into the new concept of process validation and the essentials to be considered for the CTD. The dossier requirements on process ... More
  
• 07. - 09.10.2014
  Prague: GMP-compliant Product Transfer
  In this conference, Dr. Hiltrud Horn will show how to develop a regulatory strategy for a site change covering EU and US. Furthermore Dr. Horn will present how to handle changes during a process ... More
  
• 07. - 08.10.2014
  Dessau: GMP Compliance for Vaccines and Biologics – The Bio Production Forum
  In this two days conference, Dr. Hiltrud Horn will show you what is really important for the development of biotech products. You will learn how to deal with GMP and regulatory aspects.   For ... More
  
• 16.10.2014
  Bonn: Regulatorische Anforderungen an Primärpackmittel
  In this conference, Dr. Hiltrud Horn will give detailed insight in the regulatory aspects for primary packaging material. Furthermore Dr. Horn will present how to address the information on packaging ... More
  
• 21. - 22.10.2014
  Budapest: Drug Master File Procedures in the EU, the US and Japan
  In this two days conference, Dr. Hiltrud Horn will give detailed insight into the Drug Master File Procedures in the US. You will learn how to prepare the US-DMF and will get latest updates on ... More
  
• 28. - 29.10.2014
  Mannheim: Pharmaeinkauf – GMP bei Beschaffung, Wartung und Instandhaltung
  In this two days conference, Dr. Hiltrud Horn will focus on important GMP-aspects for supply change management. Furthermore she will explain how to deal with changes of suppliers and how to stay ... More
  
• 04. - 05.11.2014
  Mannheim: Projektmanagement in Regulatory Affairs
  During this two days seminar, the attendees will learn important aspects of drug registration and project management. Dr. Hiltrud Horn will be one of the main speakers. Her talks will focus on ... More
  
• 11. - 12.11.2014
  Prague: How to write the Quality Part of an IMPD
  In this two days conference, Dr. Hiltrud Horn will give detailed insight into the Quality Part of an IMPD. Her presentations on the first day will cover regulatory requirements and challenges of the ... More
  
• 13. - 14.11.2014
  Prague: Stability Testing for Drug Substances and Drug Products
  On November 21 and 22, 2013, Dr. Hiltrud Horn will provide you with essential hints on how to write the stability section of the CTD for drug substances and drug products. Furthermore, she will talk ... More
  
• 25.11.2014
  Olten, Switzerland: MEGRA StartUp 2014-CH
  Modul XII: Blick aus der Schweiz auf das europäische und amerikanische Zulassungssystem   In this Course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in US. ... More