Chemistry Manufacturing and Controls

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Chemistry Manufacturing and Controls

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July 11 - July 12 2006 | | ,

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Event Overview

Dear Colleague,

Welcome to IIR's annual Chemistry Manufacturing and Controls conference. This year's event explores the impact of the changes that new technology and regulatory requirements have had in the areas of validation, quality by design and regulatory affairs. The mission of the 2006 conference is to provide information on how recent initiatives in CMC can help enhance patient safety, reduce the risk of attrition and increase the overall quality of the products. CMC is a continuously evolving area. With ever changing technology and requirements, one's approach to CMC must adapt.

Day One of the Conference Covers Sessions on:

Implementing Quality by Design Concepts in the Analytical Laboratory for Improved Product Quality
Quality Systems Appropriate for Early Phase Development Operations to Streamline the Development Process
The Use of Exploratory INDs and Other Initiatives to Expedite Drugs to the Market
Post-Approval Manufacturing Site Changes – Efficient and Effective Change Preparation and Implementation to Effectively Speed Drugs to Market
Sharing Strategies on Global Submissions to Help Minimize Unnecessary Time and Resources
Exploring the Options for Responses to Deficiency Letters in the US and EU to Help Expedite Approval

Day Two of the Conference Covers Sessions on:

USP Session Meeting Worldwide Compendial Requirements
Clarifying and Understanding ICH Guidance to Help Create Processes and Submissions that is Better able to Meet International Requirements
Case Study with Genzyme on the use of Online Testing in API Development and Manufacturing
When to Implement the Process Analytical Technology Initiative and the Pros and Cons of Online Testing in Drug Development
Two Part Session covering the Importance of Traditional Validation and Exploring the Alternatives

Join us at the 2006 CMC event where we help professionals working in all aspects of CMC better understand ways to enhance patient safety, reduce the risk of attrition and increase the quality of the products. We continue to bring you cutting edge information paired with expert speakers and sample networking opportunities. We look forward to greeting you on July 11, 2006, in Philadelphia, PA.

Sincerely,

Jim Goebel, PhD,
Associate Director of Science
Genzyme

Abigail Silber
Conference Producer,
Pharmaceutical Division
IIR

Valerie Bowling
Genereal Manager, Pharmaceutical
Pharmaceutical Division
IIR

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The Institute for International Research works with many accreditation boards such as NASBA, ACPE, CLE, and the Thomas Beam Institute, to give you the opportunity to receive continuing education credits. To learn more about accreditations, contact La Shawn Jackson, the Continuing Education Coordinator, at ljackson@iirusa.com.

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Event Overview

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