On behalf of the CMC Strategy Forum Global Steering Committee and CASSS, I would like to extend to you a warm welcome to the 11th meeting of the CMC Strategy Forum Europe that will be held 22-24 May 2017 in Killarney, Ireland.
The purpose of the Forum Europe 2017 is to offer a blend of topics that characterize the challenges facing the biotechnology industry in the next decade. This Forum focuses on relevant CMC issues throughout the lifecycle of a product and thereby fosters 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. The Forum will follow the established model of the CMC Forum series with focus on topics and regulatory updates relevant for Europe and will feature an opening regulatory session that will include presentations from the Health Products Regulatory Authority (HPRA), Ireland, EMA, US FDA and other European regulatory health authorities. The technical sessions will include discussions on manufacturing process development and control strategies; continuing evolution of product characterization; statistical tools in CMC; and opportunities and obstacles for accelerated CMC development.
With this exciting program, I would like to extend to you an invitation to attend and participate actively in making this Forum a great success.
On behalf of the CMC Strategy Forum Global Steering Committee