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Events 2013

• 16. – 17.04.2013
  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
  
• 07. - 08.05.2013
  Berlin: 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
  
• 14. - 15.05.2013
  Frankfurt: 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
  
• 12.06.2013
  Mannheim: Das IMPD für Biotech-Arzneimittel
  On June 12, 2013, Dr. Hiltrud Horn will present the essentials of clinical trials and will give you practical advice on the Dos and Don'ts.   For more information please visit the following ... More
  
• 16.10.2013
  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
  
• 23.10.2013
  Mannheim: Kompaktwissen pharm. Qualität für Zulassungsmitarbeiter
  In this specifically-tailored training course for Regulatory Affairs people, Dr. Hiltrud Horn will provide you with the essentials for the Quality Part of the CTD. She will talk about setting the ... More
  
• 29. - 30.10.2013
  Prague: Procurement meets GMP- GMP Requirements for Purchase and Procurement
  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
  
• 05. - 06.11.2013
  Heidelberg: 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
  
• 12. - 14.11.2013
  Vienna: 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
  
• 19. - 20.11.2013
  Barcelona: 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 ... More
  
• 21. - 22.11.2013
  Barcelona: 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
  
• 26.11.2013
  Olten, Switzerland: MEGRA StartUp 2013-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. You ... More
  
• 03. - 04.12.2013
  Heidelberg: Single-Use Disposables
  In this conference Dr. Hiltrud Horn will talk about regulatory aspects for the development of biotech products in EU and US and will also cover specifics of single-use equipment. For more ... More