|Event Name||CM2017 Workshop: Adopting Continuous Manufacturing: Defining the Platform for Success
Wednesday, February 22, 2017
Thursday, February 23, 2017
|Description||Continuous processing (‘CM’) has the potential to make the production of pharmaceuticals more responsive to patient needs. Adoption is encouraged by regulators in most regions and both industry and academia in Ireland are playing a leading role, supported by SSPC. This workshop, the second in a series following the US-based FDA-AIChE workshop in March 2016, focuses on specific elements needed to successfully deliver CM projects for API, especially:
• Regulatory considerations: expectations for filing and process validation across the product lifecycle
• Control strategy, including application of PAT
• Industry / academic collaboration for shared learning and to address open questions.
There is significant value in collaboration and standardization around these topics in order to avoid diluted effort as pharmaceutical companies, CMOs and CROs adopt the approach. Each presentation by industry, academic collaborators and relevant regulatory agencies will address the above themes and discuss the path forward in a global context. Presentations will be non-commercial and designed to help the community as a whole to move forward in this area. Breakout sessions involving all parties will discuss open issues and seek progress towards solutions as the workshop proceeds. A tour of a live operating CM facility will be available for the first 150 registrants.