Speaker presentations slides from CMC Strategy Forum Europe 2013
The Workshop, on Process Validation, was held as the initial session on the opening day and the presentations made by the speakers are available here
The purpose of the CMC Strategy Forum is to provide a venue for biotechnology/biological product discussion. The meetings focus on relevant CMC issues throughout the lifecycle of a product and thereby foster collaborative technical and regulatory interactions. The Forum strives to share information with the regulatory agencies to assist them in merging good scientific and regulatory practices.
To provide adequate opportunity for Regulatory Agency and Industry involvement, one two-day meeting will be conducted annually and will be held in Bethesda, Maryland at Lister Hill Auditorium on the NIH Campus. A one day Forum(s) will be held in conjunction with the WCBP annual meeting. In addition, as of 2007, an annual “CMC Forum Europe” will held on the European continent following a similar format to the existing US forums, and will be aimed at fostering global interactions and harmonization. Each meeting will focus on CMC related issues such as product characterization, comparability, specifications, etc. The format of each meeting will consist of case studies and presentations by Industry and/or Regulatory Agency experts to introduce the topic and the key issues of concern. Workshop sessions will then be conducted to allow for additional discussion on the technical and regulatory details of the topics.