Country Inn and Suites By Carlson , Ahmedabad, India
Feb 10 2012 8:30AM - Feb 11 2012 5:00PM
Chemistry, Manufacturing and Controls (CMC) is one of the three areas that health authorities consider for the review and approval of drug applications. Effective CMC strategies and execution may reduce regulatory burden, enable shorter review times, and support post approval maintenance.
All attendees will receive a DIA Certificate of Attendance at the conclusion of the event.
Learning Objectives:
At the conclusion of this workshop, participants will be able to: • Describe key concepts in the business, technical and execution applications of regulatory CMC
• Demonstrate process understanding, risk assessment and quality systems
• Understand the importances and emerging trends in electronic submissions and document maintenance
• Translate the development of product knowledge into effective regulatory submission content
• Enhance their organizations’ current strategies for success technical-regulatory fillings
Event Code:
12660
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Registration:
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MEETING MANAGER: Manoj Trivedi, Senior Manager Marketing and Program Development, DIA (India) Private Limited Cell: +91.98.1977.7493, Fax: +91.22.2859.4762
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