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Events 2022

• 27.01.2022
  Online Seminar: IMPD: Anforderungen an Qualitätsdaten
  Dr. Hiltrud Horn will present the challenges for preparing the Quality part of the IMPD considering latest changes of the regulation for clinical trials. Understand the new process and learn how to ... More
  
• 08.-09.02.2022
  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
  
• 10.-11.02.2022
  Live Online Seminar: 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
  
• 20.-21.06.2022
  Online Seminar: 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
  
• 23.-24.06.2022
  Online Seminar: APIs in Regulatory Affairs
  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
  
• 25.08.2022
  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
  
• 10.11.2022
  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
  
• 15.11.2022
  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
  
• 18.11.2022
  Online Seminar: ATMPs: Quality and risk management
  In this training course you will get to know the essential aspects of development and production of ATMPs. Dr. Hiltrud Horn will provide specific examples for the interpretation of GMP and regulatory ... More
  
• 24.-25.11.2022
  Online Seminar: 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