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
  • 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
  • 08. - 09 .11.2012
    Frankfurt: IMPD & CTA für Biotech-Arzneimittel
    On November 09, 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 ... More
  • 08. - 09.11.2012
    Cologne: 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

HOTLINE

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

News

  • 03.05.2012
    News for the Industry
    More
  • 19.04.2010
    EU: GMP-Annex 2 revised - Details defined for biological products including ATMPs
    More
  • 11.03.2010
    EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
    More
Get all news



Events

  • 22. - 23.05.2012
    Cologne: Der Regulatory Affairs Manager
    More
  • 19. - 21.06.2012
    Munich: 8th Bio Production Forum
    More
  • 26. - 28.06.2012
    Heidelberg: Der GMP-Beauftrage in der Biotechnologie
    More
Get all events