The CASSS CMC Strategy Forum Europe will be held 22-24 May 2017 in Killarney, Ireland. The Forum will follow the established model of the Forum series with focus on topics and regulatory updates relevant for Europe. The case study presentations are followed by panel discussions to engage all participants who have experience and expertise to share. The plenary sessions and workshops led by experts from global regulatory agencies, academia and industry provide an open forum for dialogue and exchange of scientific and technical advances that are the basis for an evolution of regulatory practices.
The technical sessions will include:
- European Biopharmaceutical Enterprises Satellite Session:
– Concept Paper 2016 Update
– ATMP – Specific Challenges in Development and Commercialization
- Regulatory Updates from Around the World
- The Continuing Evolution of Product Characterization
- Manufacturing Process, Development and Control Strategies
- Statistical Tools in CMC
- Opportunities and Obstacles for Accelerated CMC Development
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