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Events 2021

• 02.02.2021
  Online Seminar: Verunreinigungen in Arzneimitteln - Fokus Nitrosamine
  In this conference you will get to know the relevant aspects regarding nitrosamines in drug substances and drug products. Dr. Hiltrud Horn will update you on latest requirements for EU and US and ... More
  
• 09.-10.02.2021
  Live Online Seminar: 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
  
• 16.-17.03.2021
  Live Online Training: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
  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 ... More
  
• 14.-15.04.21
  Live Online Training: 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.-21.04.2021
  Live Online Training: API Regulatory Starting Materials
  In this training course about the Regulatory Affairs Know-how of Active Pharmaceutical Ingredients (APIs), Dr. Hiltrud Horn will give detailed insight into the specifications and impurity of APIs ... More
  
• 24.08.2021
  Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
  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 latest dossier requirements on ... More
  
• 28.-29.09.2021
  Live Online Training: Product Transfer - Organisation of GMP-compliant Site Change
  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 changes during a ... More
  
• 29.-30.09.2021
  Live Online Training: 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
  
• 06.-07.10.2021
  Live Online Training: 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
  
• 03.-04.11.2021
  Berlin: How to provide process validation data in regulatory submission
  Dr. Hiltrud Horn will provide the basics that CMC-people should know about process validation. You will get detailed insight into the traditional process validation and new concepts of continuous ... More
  
• 09.-11.11.2021
  Live Online Training: 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
  
• 09.-10.11.2021
  Live Online Training: Procurement and Purchase meet GMP
  In this 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 of ... More
  
• 12.11.2021
  Online Seminar: Verunreinigungen in Arzneimitteln - Fokus Nitrosamine
  This is the repetition and update of the successful seminar of February this year. In this conference you will get to know the relevant aspects regarding nitrosamines in drug substances and drug ... More
  
• 16.11.2021
  MEGRA StartUp
  Blick aus der Schweiz auf das europäische und US-amerikanische Zulassungssystem - In this course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in the US. You will ... More
  
• 23.-24.11.2021
  Live Online Training: ICH Q8 – Q11 Training Course
  In this two days conference, Dr. Hiltrud Horn will talk about the background and practical aspects of the QbD. You will understand the benefits and challenges of the QbD from practical examples. In ... More