21.11.2017

Brugg: MEGRA StartUp DRA / StartUp DRA plus 2017-CH

In this course, Dr. Hiltrud Horn will focus on the essential regulatory requirements applicable in US. You will learn how to prepare and submit INDs and NDAs and how to handle changes of your marketed products. Use this opportunity to get in-depth insight into the FDA's fundamental concepts. Learn about the importance of regulatory strategies.

For more information please visit the following website:
http://www.megra.org/fileadmin/user_upload/files/2017/events/Programm_MEGRA_StartUp_DRA_2017-CH_Final.pdf


Events: MEGRA StartUp DRA und StartUp DRA Plus 2017-CH (März - November 2017) (Conference organized by MEGRA )



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    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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    Heidelberg: Change Control – New Aspects and Best Practices
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  • 15.-17.10.2019
    Mannheim: Regulatory Compliance Expert - Arzneimittelzulassung für Mitarbeiter aus dem GMP-Umfeld
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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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