Events 2012

  • 13. - 14.03.2012
    Berlin: 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
  • 15. - 16.03.2012
    Vienna: 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
  • 09. - 10.05.2012
    Brussels: Filing Variations 2012
    In this two days conference, Dr. Hiltrud Horn will give a presentation on how to deal with change control within a global company.   For more information please visit the following ... More
  • 22. - 23.05.2012
    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 ... More
  • 19. - 21.06.2012
    Munich: 8th 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
  • 26. - 28.06.2012
    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
  • 12. - 13.09.2012
    Prague: GMP-compliant Process Transfer
    In this conference, Dr. Hiltrud Horn will show how to develop a regulatory strategy for a site change covering EU and US. Furthermore Dr. Horn will present how to handle changes during a process ... More
  • 18.09.2012
    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
  • 02.10.2012
    Mannheim: FDA kompakt: Organisation, Systeme, Compliance
    In this conference, Dr. Hiltrud Horn will give detailed insight into the essentials about regulatory requirements in US and preparation of dossiers in US (IND, NDA, DMF). Furthermore Dr. Horn will ... More
  • 10. - 12.10.2012
    Heidelberg: GMP Compliance for Biopharmaceuticals and ATMP
    During this three days seminar, the attendees will learn important GMP- and regulatory aspects of the development of biopharmaceuticals and ATMPs. Dr. H. Horn will give several presentations ... More
  • 18. - 19 .10.2012
    Frankfurt: IMPD & CTA für Biotech-Arzneimittel
    On October 19, 2012, 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
  • 08. - 09.11.2012
    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
  • 13. - 14.11.2012
    Vienna: 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
  • 14. - 15.11.2012
    Mannheim: Pharmaeinkauf und GMP compliance
    In this two days conference, Dr. Hiltrud Horn will focus on important GMP-aspects for supply change management. Furthermore she will explain how to deal with changes of suppliers and how to stay ... More
  • 27. - 28.11.2012
    Barcelona: Stability Testing for Drug Substances and Drug Products
    On November 27 and 28, 2012, 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 ... More
  • 04. - 05.12.2012
    Mannheim: Single-Use Disposables
    In this conference Dr. Hiltrud Horn will talk about regulatory aspects for the development of biotech products in EU and US and will also cover specifics of single-use equipment. For more ... More

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
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Events

  • 08.05.2019
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
    More
  • 14.-15.04.2019
    Cologne: Der Regulatory Affairs Manager
    More
  • 16.-17.05.2019
    Vienna: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
    More
Get all events



News

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