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Events 2016

• 26.01.2016
  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
  
• 16. - 17.02.2016
  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
  
• 23. – 24.02.2016
  Prague: API Regulatory Starting Materials
  On February 23, Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). Furthermore, she will share her experience in a workshop ... More
  
• 13. - 14.04.2016
  Heidelberg: GMP Compliance for Biopharmaceuticals and ATMP
  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
  
• 10. - 11.05.2016
  Cologne: 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
  
• 20. – 21.09.2016
  Prague: API Regulatory Starting Materials
  In this two days conference, Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). Furthermore, she will show how to handle ... More
  
• 22. – 23.09.2016
  Heidelberg: Beschaffung trifft GMP - Anforderungen und Umsetzung von GMP-Compliance bei Beschaffung und Einkauf
  In this two days conference, Dr. Hiltrud Horn will focus on important GMP-aspects for supply change management. Typical cases will be presented. Furthermore she will explain how to deal with changes ... More
  
• 30.09.2016
  Frankfurt: Prozessvalidierung - Update für CMC
  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
  
• 05.10.2016
  Mannheim: Genotoxische Verunreinigungen
  In this course, you will learn how to deal with genotox impurities and what is relevant for the CMC-dossier. Learn about the challenges of these impurities from development to registration. Think ... More
  
• 06. – 07.10.2016
  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
  
• 12.-13.10.2016
  Berlin: Quality by Design in API manufacturing
  In this two days conference, Dr. Hiltrud Horn will give presentations on the key elements and strategies for the QbD of APIs. Furthermore, you will learn how to provide information on the development ... More
  
• 18. – 19.10.2016
  Vienna: 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
  
• 20. – 21.10.2016
  Karlsruhe: Regulatory Compliance Expert - Arzneimittelzulassung für Mitarbeiter aus dem GMP-Umfeld
  In this conference, Dr. Hiltrud Horn will give detailed insight into typical CMC-issues that a CMC Manager or CMC-team leader should know. Apart from EU she will guide you through the registration ... More
  
• 25. - 27.10.2016
  Berlin: Product Transfer - Organisation of GMP-compliant Site Change
  On October 26, Dr. Hiltrud Horn will show how to develop a regulatory strategy for a site transfer covering EU and US. Furthermore Dr. Horn will present how to handle with additional unplanned ... More
  
• 08. – 09.11.2016
  Düsseldorf: PharmaLab 2016 – Bioanalytik, Bioassays und Stabilitätsprüfung
  On October 8, 2016, Dr. Hiltrud Horn will provide you with essential hints on the development of biotech products in EU and US. She will show the essentials from the GMP and the regulatory point ... More
  
• 10. - 11.11.2016
  Vienna: 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
  
• 21. - 22.11.2016
  Frankfurt: 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