Events 2020

11.-12.02.2020
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
18.02.2020
Frankfurt: Nitrosamine Impurities
In this conference you will get to know the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances and drug products. Dr. Hiltrud Horn will ... More
19.03.2020
Online Training: Nitrosamine Impurities
Repetition of the seminar due to high demand. In this conference you will get to know the relevant aspects of risk mitigation with respect to potential Nitrosamine contamination in drug substances ... More
21.-22.04.2020
Heidelberg: 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
05.05.2020
Live Online Seminar: 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
19.-20.05.2020
Online Training: 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. Due to ... More
13.-14.07.2020
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 ... More
25.08.2020
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
06.-07.10.2020
Live Online Training: 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
08.-09.10.2020
Live Online Training: 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
13.-14.10.2020
Live Online Training: 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.-22.10.2020
Live Online Training: 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
29.-30.10.2020
Live Online Training: 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
04.-05.11.2020
Live Online Training: 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
10.-12.11.2020
Live Online Training: 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
25.-26.11.2020
Online Seminar: 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. Furthermore, ... More
02.-03.12.2020
Prague: 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
03.-04.12.2020
Prague: 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
08.-09.12.2020
Live Online Training: 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
10.-11.12.2020
Cologne: 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

HORN Pharmaceutical Consulting
CMC â€“ GMP â€“ Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schlo? 1
D-76646 Bruchsal
Germany

Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
e-mail: info@horn-pharma.de
Internet: www.horn-pharma.de

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Events

25.08.2020
Online Seminar: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
More
06.-07.10.2020
Live Online Training: Change Control – New Aspects and Best Practices
More
08.-09.10.2020
Live Online Training: ICH Q8 – Q11 Training Course
More

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News

18.05.2020
Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
More
26.03.2020
New Deadline for Nitrosamine Impurities
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24.03.2020
News on Nitrosamine Impurities
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Get all news

EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?

EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.

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