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CASSS Community News - August 30, 2018
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CMC JAPAN|MIDWEST REGIONAL FORUM|NORTHERN CALIFORNIA REGIONAL FORUM|DC DISCUSSION GROUP


CMC StrategyForum Japan Registration Now Open!

Don’t miss the opportunity for in-depth discussions and interactions with regulators at CMC Strategy Forum Japan 2018. Regulatory agencies who attended last year include:

Canada– Health Canada
China– China Food and Drug Administration
Finland– Finnish Medicines Agency*
*representing the European Medicines Agency
Japan– Pharmaceuticals and Medical Devices Agency
Korea– Ministry of Food and Drug Safety
Sweden– Medical Products Agency
United States– Food and Drug Administration



Midwest Regional Forum Program Updates

Work Smarter Not Harder - Leveraging Prior Knowledge to Accelerate CMC Programs

This Forum will explore strategies to speed delivery of material to the clinic for FIH trials by using prior knowledge and project platform approaches. Speakers will also discuss strategies about streamlining development studies to lock down process decisions earlier in the development cycle. Finally, we will discuss case studies to explore how companies are using prior knowledge.

Top Five Reasons to Attend:

  • Understand regulatory perspectives on leveraging prior knowledge to accelerate CMC development
  • Gain industry perspective on accelerating formulation development
  • Dive into risk-based approaches to streamlining CMC programs
  • Discuss practical application of risk-based approaches for shipping validation
  • Participate in a case study on risk-based approaches for ADC’s development


Northern California Regional Forum
Cell and Gene TherapiesProgram Updates

Registration is now open for the CASSS Northern California Regional Forum. Join us as we explore the hot topic of Cell and Gene Therapies. This forum will provide practical discussion on CMC considerations, challenges and opportunities as more cell & gene therapies gain regulatory approval. Past attendees of the CASSS Regional Forums have said:

“The Regional Forums provide a valuable forum for industry to come together to talk about issues and best practices.”
-Bem A.

“This conference presented excellent value. Great price point and easy access made it very easy to get funds to attend.”
-Carol K.



The DC Discussion Groups Are Back!

Join CASSS for another year of DC Discussion Groups. These bi-monthly events are the perfect opportunity to discuss industry hot topics, network with colleagues, and exchange new ideas.
Join us this fall!

New Technology and Academic Discovery
Thursday, October 8
3:00 - 5:30 PM
IBBR


Not from the DC Area? CASSS offers local programming around the United States and the Netherlands. Visit the CASSS website for more information!


Upcoming CASSS Meetings


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