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Events 2017

• 07. - 08.02.2017
  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
  
• 22. - 23.03.2017
  Frankfurt: CMC Documentation & Post-Approval Changes/ Variations
  During this two days seminar, Dr. Hiltrud Horn will provide an update on latest changes for clinical trials, explain the new process and show you what is relevant for your CMC-part of the IMPD. ... More
  
• 04.-05.04.2017
  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
  
• 25. - 27.04.2017
  Madrid: E-Regulatory Summit including Filing Variations
  At this conference Dr. Hiltrud Horn will talk on day 3 about filing variations in EU and how they compare to US-requirements. She will give detailed insight into the differences of change ... More
  
• 03. – 04.05.2017
  Vienna: 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. Typical cases will be presented. Furthermore she will explain how to deal with changes ... More
  
• 09. - 10.05.2017
  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 ... More
  
• 11.-12.05.2017
  Kopenhagen: 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
  
• 16.05.2017
  Darmstadt: 8. Merck Pharma-Forum 2017
  At this Merck Pharma Forum Dr. Hiltrud Horn will talk about the expectations on active substances and on excipients for the development of the drug product. You will learn about functionality ... More
  
• 18.05.-19.05.2017
  Kopenhagen: 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
  
• 23.-24.05.2017
  Berlin: 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
  
• 12.06.2017
  Berlin: Outsourcing from API to Drug Product - (GMP and regulatory Perspective in EU and US)
  This course will focus on individuals that have input into supply chain management decisions, or who have oversight or actively manage technology transfers in EU or US. Particularly, Dr. Hiltrud ... More
  
• 20.06.2017
  Bonn: IMPD Biotech - Kommende 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 ... More
  
• 30.-31.08.2017
  Bonn: 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
  
• 14.09.2017
  Mainz: 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 latest dossier requirements on ... More
  
• 26.-27.09.2017
  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
  
• 28.-29.09.2017
  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
  
• 11.10. - 12.10.2017
  Heidelberg: 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 ... More
  
• 07. - 09.11.2017
  Prague: 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
  
• 09. - 10.11.2017
  Bonn: 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
  
• 14.-15.11.2017
  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
  
• 15.-17.11.2017
  Berlin: Regulatory Compliance Expert
  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
  
• 20.11.2017
  Bonn: API und Starting Materials - Anforderungen an CMC
  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. Furthermore, ... More
  
• 21.11.2017
  Brugg: MEGRA StartUp DRA / StartUp DRA plus 2017-CH
  In this course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in US. You will learn how to prepare and submit INDs and NDAs and how to handle changes of your ... More
  
• 23.-24.11.2017
  Barcelona: 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
  
• 28.-29.11.2017
  Vienna: 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
  
• 29.-30.11.17
  Vienna: 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