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CMC Forum January 2018: Introduction
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The CMC Strategy Forum has established an excellent reputation for being the premier scientific meeting that brings together regulatory, industry and academic professionals to discuss key emerging CMC issues that affect Biotechnology in an open and transparent workshop format. The Forum had its beginning in the United States in 2002, with three Forums now being held each year - two in conjunction with the Well Characterized Biotechnology Products (WCBP) Symposia series in January and one typically in July near the US Food and Drug Administration campus in Silver Spring, Maryland.

The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion on relevant CMC issues throughout the lifecycle of a product. The outcomes of the Forums are:

     • To foster collaborative technical and regulatory interactions that advance discussions to consensus concepts;
     • To provide the information to the FDA to allow them to merge good scientific practices with good regulatory practices for our mutual benefit.

It is envisioned that the final outcome of the workshop discussions will be the development of a document to be submitted to the appropriate Regulatory Agency designees for their consideration in developing and/or clarifying good regulatory practice guidelines for biotechnology derived products and that will help assure the biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.

The success of the Forum series further demonstrates the benefits and need for providing an open forum for dialogue and exchange of scientific and technical advances that are the basis for evolution of regulatory practices. 
 

Topics for Discussion

The North America Committee is developing and maintaining a topic list for future Forums.  Discussion topics are taken from WCBP workshops and participant suggestions.  To suggest a topic, please contact a member of the North America Committee or Karen Bertani at CASSS (kbertani@casss.org).

 


 



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