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Events 2018

• 06.-07.02.2018
  Heidelberg: 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
  
• 13.03.2018
  Mannheim: Die FDA nach dem MRA: Grundlagen und aktuelle Entwicklungen (QS 3)
  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
  
• 23.03.2018
  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
  
• 23.-24.04.2018
  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
  
• 03.-04.05.2018
  Heidelberg: 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.-09.05.2018
  Barcelona: 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
  
• 15.-16.05.2018
  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
  
• 17.-18.05.2018
  Berlin: 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
  
• 19.-20.06.2018
  Berlin: 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
  
• 21.-22.06.2018
  Berlin: GMP for Advanced Therapy Medicinal Products (ATMP)
  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
  
• 26.06.2018
  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
  
• 30.08.2018
  Bonn: 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
  
• 18.-19.09.2018
  Mannheim: Beschaffung trifft GMP - Anforderungen und Umsetzung von GMP-Compliance bei Beschaffung und Einkauf
  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
  
• 19.-20.09.2018
  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
  
• 25.-27.09.2018
  Barcelona: 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.-11.10.2018
  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
  
• 23.-24.10.2018
  Hamburg: 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
  
• 06.-07.11.2018
  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
  
• 13.-14.11.2018
  Berlin: ICH Q12 - Product Life Cycle Management
  In this conference, Dr. Hiltrud Horn will provide you with essential information regarding the ICH Q12 Guideline. You will learn how the ICH Q8-Q12 Guideline work together from Development to Product ... More
  
• 15.11.2018
  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
  
• 20.11.2018
  Brugg: MEGRA StartUp DRA / StartUp DRA plus 2018-CH
  In this course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in the US. You will learn how to prepare and submit INDs and NDAs and how to handle changes of your ... More
  
• 20.-21.11.2018
  Neuss: cGMP Compliance Trends PharmaLab 2018 – Bioanalytik, Bioassays und Stabilitätsprüfung
  On November 21st, 2018, Dr. Hiltrud Horn will provide you with essential GMP news in EU and current trends at FDA. You will learn how to ensure compliance and avoid data integrity problems. After the ... More
  
• 22.-23.11.2018
  Berlin: 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.-28.11.2018
  Barcelona: 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
  
• 28.-29.11.2018
  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
  
• 29.-30.11.2018
  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