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Events 2010

• 26. - 28.01.2010
  Paris: Conference on Investigational Medicinal Products
  On 28 January 2010, Dr. Hiltrud Horn will give a one day- training course on the “Investigational Medicinal Product Dossier (IMPDs)”. Her presentation will cover the increasing requirements on GMP ... More
  
• 11. - 12.03.2010
  Barcelona: 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
  
• 03. – 04.05.2010
  Frankfurt/Offenbach: IMPD für Biotech-Arzneimittel
  On 3 May 2010, Dr. Hiltrud Horn will give detailed insight into the IMPD with various aspects of how to compile, organise and word successfully the dossier. On 4 May 2010, Dr. Hiltrud Horn ... More
  
• 08. – 09.06.2010
  Heidelberg: The new EU Variations Regulation and supporting Guidelines
  In this two days conference, Dr. Hiltrud Horn will give presentations on how to deal with manufacturing process changes and with packaging changes. For more information please visit the following ... More
  
• 14.06.2010
  Berlin: Development of Biotech Products and Advanced Therapy Medicinal Products (ATMPs) - Regulatory and GMP-Aspects -
  Dr. Hiltrud Horn will give a one day- training course on “Development of Biotech Products and Advanced Therapy Medicinal Products (ATMPs) - Regulatory and GMP Aspects”. Her presentation will focus ... More
  
• 15.06.2010
  Berlin: PDA Workshop on Advanced Therapy Medicinal Products: ATMPs – 21st Century Pharmaceuticals, a New Paradigm
  In this one day workshop, Dr. Hiltrud Horn will give detailed insight into the GMP expectations on the manufacture of biological medicinal products. Her presentation will focus on the reality for ... More
  
• 15. – 17.06.2010
  Geneva: Bio Production Forum
  In this three days conference, Dr. Hiltrud Horn will cover the topic of “Marketing Authorisation”. Her presentation will cover the way from clinical trials to Marketing Authorisation Application ... More
  
• 22. – 23.06.2010
  Brussels: Filing Variations 2010
  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
  
• 23. – 24.09.2010
  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
  
• 28.09.2010
  Cologne: Regulatorische Anforderungen an Primärpackmittel
  In this conference, Dr. Hiltrud Horn will give detailed insight in the regulatory aspects for primary packaging. Furthermore Dr. Horn will present how to address the information on packaging in the ... More
  
• 20. - 21.10.2010
  Frankfurt: IMPD für Biotech-Arzneimittel
  On October 20, 2010, Dr. Hiltrud Horn will give detailed insight into the IMPD with various aspects of how to compile, organise and word successfully the dossier. On October 21, 2010, Dr. ... More
  
• 26. – 27.10.2010
  Mannheim: Die FDA: Organisation, Systeme, Compliance
  During this two days seminar, 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. ... More
  
• 11. - 12.11.2010
  Vienna: 2010 PDA Europe Workshop on Analytical Method Validation
  On November 11, 2010, Dr. Hiltrud Horn will moderate a session on "Analytical Validation Approaches" together with Susan Schniepp. Further Details about the Workshop: This Workshop ... More