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CMC Forum January 2018: Scientific Program
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Preliminary Program Coming Soon!

 

 


 

Method Qualification vs. Validation - What Does That Mean Now?

The 2018 CMC Strategy Forum will target the policies and practices specifically related to phase-appropriate method validation for QC testing of clinical trial materials, and method qualifications for R&D methods used only for characterization, comparability and biosimilarity studies. The Forum will encompass technical strategies to support a method’s ‘intended use’, quality practices to document ‘assurance’ that methods are scientifically sound, and regulatory expectations for what should be provided ‘upon request’ by a regulatory agency for these types of methods.  Forum discussions will focus on identifying and mitigating elements of greatest risk to the reliability of testing results in any CMC analytical lab at any phase of development.

To view the full Forum Abstract, click HERE.  


Prior Knowledge: Learning from our Successes and Failures to Improve Product Development and Manufacturing

 Biotechnology-based therapeutic products have been on the market for almost 35 years. Through that time, the biopharmaceutical industry and regulatory authorities around the world have together brought hundreds of biological drugs to patients suffering from a variety of diseases. The development and manufacture of new products is often based on the same principles and technologies. There is now a wealth of prior knowledge that we can and should leverage to improve the efficiency of developing new products and the manufacturing of existing products. Some areas of CMC already use prior knowledge effectively such as in the validation supporting facility design, or in the design of viral clearance and inactivation studies. Although the potential is clear, and it’s time to expand upon existing efforts, how a given manufacturer maintains, interprets and applies such a large amount of information across multiple products in a regulated environment remains a challenge. This Forum will explore ways the industry can push these concepts to speed drug development and enhance manufacturing efficiency to get safe and effective products to patients as quickly as possible.


To view the full Forum Abstract, click HERE.

 


more Calendar

12/4/2017 » 12/5/2017
CMC Strategy Forum Japan 2017

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