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IIR PTI
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| Understanding US-FDA Drug Submission Procedures |
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Thu 22 Apr 2010
- Fri 23 Apr 2010
Venue to be confirmed, London, England
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Thu 09 Sep 2010
- Fri 10 Sep 2010
Regus St. James's Park, London, England
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How can you avoid receiving a FDA non-approvable letter? Do you want to be responsible for delaying your drug submission in the USA because you failed to supply the right registration dossier? In the challenging environment of US drug registrations procedures, you need to understand all the current procedures. To help you do this, IPT has developed this course to clarify the US regulatory process. By attending , you will gain a practical insight into FDA’s requirements for new drug development and prepare your new drug registration dossier accordingly to US guidelines.
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Very interesting course. Gives you a broad overview of the FDA governance
Jr Project Associate RA, Centocor B.V.
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Who Will Attend?
Regulatory Affairs Managers/ Officers / Assistants Compliance Managers Documentation Managers Product Registration personnel Project Managers in Regulatory Affairs Marketing Managers Clinical Research Personnel Key contributors to the submission package for the US market
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Course Leader
Carolyn H Kruse, President, KRUSE CONSULTING GROUP, Inc. Caroline has extensive experience in multinational pharmaceutical development - skilled in international and US regulatory affairs, pharmaceutical manufacturing, technology transfer and project management. Caroline has worked for 25 years in the pharmaceutical industry
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