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The Center for Professional Advancement, Boca Raton, FL
February 25-26, 2008
Who Should Attend
This course is intended for all personnel in all pharmaceutical companies especially those in:- Regulatory Affairs
- Chemistry and Analytical Departments
- Pre-formulation
- Pharmaceutical Development
- QA/QC for the CMC section of the NDA/CTD
It is recommended that you have at least one year experience in either regulatory affairs, chemistry, analytical, QA/QC or pharmacy department or pharmaceutical development to fully benefit from this course.Description
This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and European regulatory bodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICH requirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stability issues as they apply to the drug substance and drug product. In addition, details on supplemental applications for changes to an NDA will be presented focusing on SUPAC requirements.
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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Carolyn H. Kruse, MSc., M.TOPRA; Consultant to the Pharmaceutical Industry
Carolyn Hoskins Kruse is President of Kruse Consulting Group, a regulatory and drug development consulting firm established in 1995. She has extensive experience in multinational pharmaceutical development, and is skilled in international and US regulatory affairs, pharmaceutical manufacturing, technology transfer, multinational project management, and training in the Drug Development and Approval process.
Ms. Kruse has worked in the pharmaceutical industry for over 30 years. As a Project Director at Sterling Winthrop Pharmaceutical Research Division (now Sanofi-Aventis), she was responsible for defining global development strategies for drugs in a variety of therapeutic areas including cardiovascular (Plavix®), antibiotic, vaccine, endocrine (diabetes, osteoporosis) and antioxidant projects. Ms. Kruse directed multinational project teams during Sterling’s alliance with Sanofi Recherche, now Sanofi Aventis, creating a results-oriented environment, ensuring timelines were met to enhance the company business goals.
Prior to working for Sterling Winthrop, Ms. Kruse was employed by SmithKline Beecham Pharmaceuticals (now Glaxo Smith Kline) in the US/International Regulatory Affairs and Medicinal Chemistry departments. During three years working in the UK, she was responsible for completing submissions to the UK MHRA, the Irish NDAB and the EU CPMP. As a research chemist, Ms. Kruse was the senior author and/or co-author of twelve research papers that were published in peer reviewed scientific journals.
Ms. Kruse is a member of the Drug Information Association, the Regulatory Affairs Professional Society and The Organization for Professionals in Regulatory Affairs.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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info@cfpa.com
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