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Events 2019

• 31.01.-01.02.2019
  Bonn: IMPD Biotech - Neue Anforderungen an die Qualitätsdokumentation
  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
  
• 26.-27.02.2019
  Mannheim: 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.-20.03.2019
  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
  
• 26.-27.03.2019
  Copenhagen: 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
  
• 02.-03.04.2019
  Cologne: Wirkstoffe/APIs - Regulatory Affairs Know-how
  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
  
• 10.-11.04.2019
  Hamburg: 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
  
• 08.05.2019
  Mannheim: Aktuelle Trends in der Qualitätskontrolle
  In this conference, Dr. Hiltrud Horn will focus on GMP compliance trends in analytical laboratories. In the first talk, she will update you on latest GMP-trends, explain you the implications of ... More
  
• 14.-15.04.2019
  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
  
• 16.-17.05.2019
  Vienna: 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
  
• 23.-24.05.2019
  Barcelona: 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
  
• 26.-27.06.2019
  Vienna: GMP for Advanced Therapy Medicinal Products
  In this training course you will get to know the essential aspects of the new GMP-Guideline for ATMPs, considering the specifics during clinical development. You will also learn how to handle ... More
  
• 29.08.2019
  Frankfurt: Prozessvalidierung - Aktuelle Anforderungen 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 latest dossier requirements on ... More
  
• 17.-18.09.2019
  Copenhagen: 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
  
• 27.09.2019
  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 ... More
  
• 08.-09.10.2019
  Heidelberg: 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
  
• 15.-17.10.2019
  Mannheim: 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
  
• 22.-24.10.2019
  Vienna: Product Transfer - Organisation of a 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
  
• 23.-24.10.2019
  Vienna: 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
  
• 29.-30.10.2019
  Hamburg: 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
  
• 13.-14.11.2019
  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
  
• 19.11.2019
  Brugg: 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 ... More
  
• 27.-28.11.2019
  Barcelona: Setting Specifications and Acceptance Criteria
  Dr. Horn will explain strategies defining specifications for excipients and container closure systems in EU and US. Her presentation will cover the essential aspects for setting the right ... More
  
• 28.-29.11.2019
  Barcelona: Stability Testing for Drug Substances and Drug Products
  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 about post-marketing ... More
  
• 04.-05.12.2019
  Bonn: APIs in Regulatory Affairs
  Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). She will also explain the differences in CEPs, ASMFs and DMFs. ... More