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Pre-Conference Focus Day

Taking place on Tuesday January 28, 2020 - Pre-conference

This focus day will encompass short presentations on regulatory affairs, CMC and continuous manufacturing business decisions. Through group discussions, you will be able to understand how to lead a successful CM project.  Delegates must select this option additionally on registration for the CCP Summit (not included in the conference only option).  

8:30 am Registration & Welcome Coffee

9:00 am US Pharmacopeia and ICH Q13 Quality Draft Guidance Updates

  • Atul Dubey Director, Pharmaceutical Continuous Manufacturing, US Pharmacopeia

Synopsis

• Status update on draft guidance
• The importance of defining a common quality framework globally to help promote CM development
• The next phase and Q&A

9:30 am A Discussion of Selected Regulatory Feedback Ahead of and After Filing a Multistage Continuous Process to API

Synopsis

• The value of the pre-operational visit
• Observations of common themes and differences between agencies
• Feedback post file

10:00 am Ice Breaking Session

10:30 am Coffee Break

11:00 am When Should You Start Considering Continuous Manufacturing?

11:30 am Group Discussion & Feedback

12:30 pm Networking Lunch

1:30 pm Continuous Manufacturing – Go or No Go?

  • Jana Spes Head of Pharmaceutical Development & Manufacturing Sciences, Ironwood Pharmaceuticals

Synopsis

• From product type to costs of goods – how do you draw up the business case to decide on manufacturing approach?
• Pros and cons of batch vs CM
• Scalability and investment requirements
• Risks and timeline
• The final steps of making the go/no go decision

2:00 pm From Design to Building – What Does it Take to Commission a Successful Continuous Manufacturing Fleet?

Synopsis

• Project management to commission a multi-billion continuous manufacturing asset worldwide
• Validate and filing challenges and lessons learned

2:30 pm Group Exercise to Draw Up Your Own Continuous Manufacturing Development Plan

3:30 pm Discussion

4:00 pm End of Focus Day