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 process of drugs in the US (FDA). She will share her experience in a workshop with case studies from current CMC-projects. Learn about CMC-strategies and take the chance to benefit from the exercises for your daily work. Furthermore detailed insight will be provided on dealing with variation and changes in EU and US and about the challenges in a global environment. You will understand the agencies and their approach in dealing with your CMC-changes.

For more information please visit the following website:
https://www.gmp-navigator.com/daten/seminarpdf/Regulatory-Compliance-Expert.pdf


(Conference organized by Concept Heidelberg)

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Events

  • 29.08.2019
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
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  • 17.-18.09.2019
    Copenhagen: Drug Master File Procedures in the EU, the US and Japan
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  • 27.09.2019
    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
    More
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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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