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CMC Strategy Forum Europe 2016
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Monday, 9 May 2016 - Wednesday, 11 May 2016


Marriott Rive Gauche, Paris, France


 



 

  

 

Thank you to all who participated in the CMC Strategy Forum Europe 2016!  
Mark your calendars now for the CMC Strategy Forum Europe 2017: 22 - 24 May 2017 in Killarney, Ireland.  
 

On behalf of the CASSS Board of Directors and the CMC Strategy Forum Global Steering Committee, I would like to extend to you a warm welcome to the 10th anniversary meeting of the CMC Strategy Forum Europe 2016 that will be held 9-11 May in Paris, France. 

The purpose of the Forum Europe 2016 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 EMA, ANSM, US FDA and other European regulatory health authorities. The technical sessions will include discussions on continuous process verification; combination trials and combination products; innovative approaches for tools and technology; and an overview of ICH Q12 with emphasis on approved matters/established conditions and post-approval change management protocol (PACMP).

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. 

Wassim Nashabeh
On behalf of the CMC Strategy Forum Global Steering Committee



 

 

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Featured Members
Julia Edwards, AllerganJulia Edwards is an Executive Director with Allergan.

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