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Register by June 1st
and receive a $300 discount! |
PRE-FILLED SYRINGES FORUM 2012
Strategic Development, Inspection, Safety & Regulatory Compliance and Commercialization of Pre-Filled Syringes |
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July 26-27, 2012, Sheraton La Jolla Hotel, La Jolla, CA |
Featuring Case Studies and Lessons Learned from Industry Experts!
- Materials, Design & Construction of Pre-Filled Syringes
- Safety Considerations & Requirements
- Numerous Development Case Studiess
- Manufacturing & Filling Solutions
- Regulation & Inspection of Pre-Filled Syringes
- Future Materials for Pre-Filled Syringe Components
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View Brochure I Register
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Register by May 1st
and receive a $300 discount! |
Development & Regulation of Prefilled
Syringes & Advanced Injection Devices
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June 25 - 26, 2012, Racquet Club of Philadelphia - PHILADELPHIA, PA |
- Review FDA combination product regulatory frameworks and contrast to EU approach
- Review the current state of combination product quality system regulations
- Discuss how to manage the reporting of post-approval changes to an NDA or BLA containing a prefilled or kitted drug delivery device
- Develop a strategic approach to solving technical and regulatory challenges in the development and manufacturing of drug-device
combination products
- Analyze a variety of prefilled and kitted drug delivery devices and technologies and accessory safety devices
- Consider clinical testing paradigms and study designs for drug, biologic and medical devices including Human Factors Design Validation studies
- Examine development and regulatory strategies for switching presentations from vials to prefilled syringes and advanced injection devices
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View Brochure I Register
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Testimonials
"This event was the best I've attended in years!"
"Great speakers, great facilitation -- a 10!"
"We look forward to your next event.
It was a very positive learning experience!" |
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