14.-15.04.2019

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 variations. Furthermore she will talk about how to plan and prepare regulatory documents and how to cope with regulatory procedures and timelines. Learn how to stay compliant in an international environment.

For more information please visit the following website:
https://www.forum-institut.de/seminar/1905230-der-regulatory-affairs-manager


(Conference organized by FORUM Institut)

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Events

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    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
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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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