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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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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 ...
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News
03.05.2012
News for the Industry
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19.04.2010
EU: GMP-Annex 2 revised - Details defined for biological products including ATMPs
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11.03.2010
EU: IMPD requirements for the Quality part of biological/biotechnology derived substances defined
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Events
22. - 23.05.2012
Cologne: Der Regulatory Affairs Manager
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19. - 21.06.2012
Munich: 8th Bio Production Forum
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26. - 28.06.2012
Heidelberg: Der GMP-Beauftrage in der Biotechnologie
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