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Events 2015
10. - 11.02.2015
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 ...
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12. – 13.02.2015
Barcelona: API Regulatory Starting Materials
On February 12, Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). Furthermore, she will share her experience in a workshop ...
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04. - 05.03.2015
Frankfurt: CMC Documentation & Post-Approval Changes/ Variations
During this two days seminar, Dr. Hiltrud Horn will give detailed insight into opportunities of the latest process validation guideline and will show how to apply and benefit from it. For ...
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14. - 15.04.2015
Berlin: Serialisation & Authentication
In this two days conference, Dr. Hiltrud Horn will present how to deal with the implementation of the falsified medicines directive (e.g. barcode and safety features) and which regulatory aspects ...
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28. – 29.04.2015
Barcelona: 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 ...
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19. - 20.05.2015
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 ...
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18. – 19.06.2015
Vienna: 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 ...
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21.09.2015
Frankfurt: Prozessvalidierung - aktuelle Herausforderungen für Regulatory Affairs
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 dossier requirements on process ...
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29.09.2015
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 ...
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06. – 07.10.2015
Hamburg: API Regulatory Starting Materials
On October 06, Dr. Hiltrud Horn will give various presentations on the challenges and practical implications of starting materials (API). Furthermore, she will show how to handle post-approval ...
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06. – 07.10.2015
Heidelberg: Beschaffung trifft GMP - Anforderungen und Umsetzung von GMP-Compliance bei Beschaffung und Einkauf
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 ...
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15. – 16.10.2015
Mannheim: 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 ...
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20. - 22.10.2015
Berlin: Product Transfer - Organisation of GMP-compliant Site Changes
In this conference, 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 ...
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22. - 23.10.2015
Hamburg: 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 ...
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03. - 04.11.2015
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 ...
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10. – 11.11.2015
Düsseldorf: PharmaLab 2015 – Bioanalytik, Bioassays und Stabilitätsprüfung
On October 10, 2015, Dr. Hiltrud Horn will provide you with essential hints on the development of biotech products in EU and US. She will show the essentials from the GMP and the regulatory point of ...
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10. – 11.11.2015
Berlin: Setting Specifications and Acceptance Criteria
strategies defining specifications for excipients and container closure systems in EU and US. Her presentation will cover the essential aspects for setting the right specifications in the CTD. ...
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11. - 12.11.2015
Berlin: Stability Testing for Drug Substances and Drug Products
On November 11 and 12, 2015, 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 ...
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17. - 18.11.2015
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 ...
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24.11.2015
Brugg: Switzerland: MEGRA StartUp 2015-CH
Modul XII: Blick aus der Schweiz auf das europäische und amerikanische Zulassungssystem In this course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in US. ...
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25.11.2015
Mannheim: Genotoxische Verunreinigungen
In this course, you will learn how to deal with genotox impurities and what is relevant for the CMC-dosier. Learn about the challenges of these impurities from development to registration. Think ...
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01. – 02.12.2015
Berlin: How to provide process validation data in regulatory submissions
On December 01, 2015 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 ...
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19.12.2022
EU Update regarding Deadlines of Nitrosamine Impurities
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01.09.2022
EU-GMP Annex 1 finally published
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26.08.2022
New Deadlines and Chances for Nitrosamines
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