Events 2011

  • 10. - 11.03.2011
    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 ... More
  • 10. - 11.05.2011
    Prague: 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
  • 08. - 10.06.2011
    Ulm: 7th Bio Production Forum
    In this three 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. For more ... More
  • 04. - 06.07.11
    Heidelberg: Der GMP-Beauftrage in der Biotechnologie
    In this three days conference, Dr. Hiltrud Horn will give detailed insight in the Process Transfer from Development to Commercial Manufacturing with a case study. Her presentation will cover the ... More
  • 22.09.2011
    Cologne: 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 ... More
  • 29. - 30.09.11
    Frankfurt: Projektmanagement in Regulatory Affairs
    During this two days seminar, the attendees will learn important aspects of drug registration (CTD) and project management. Dr. Hiltrud Horn will be one of the main speakers.   For more ... More
  • 27. - 28.10.2011
    Frankfurt: IMPD & CTA für Biotech-Arzneimittel
    On October 28, 2011, Dr. Hiltrud Horn will present the essentials of clinical trials and will give you practical advice on the Dos and Don'ts. For more information please visit the following ... More
  • 29. - 30.11.2011
    Munich: How to write the Quality Part of an IMPD
    In this two days conference, Dr. Hiltrud Horn will give detailed insight in the Quality Part of an IMPD. Her presentations on the first day will cover regulatory requirements and challenges of the ... More

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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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