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June 28-30 2016

Boston

Day One

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Wednesday June 24th 2015

Day Two
Thursday June 25th 2015

SUMMARY AGENDA

08:00
Breakfast & Registration

09:00
Chairman’s Opening Remarks

  • Stephen Barat Executive Director, Toxicology, Preclinical Pharmacology , and Bioanalytical Strategy, Actavis

Building the Right Team

09:10
The Building Blocks of PFS: What we Know and Needs to be Discovered

Synopsis

 

  • Industry known challenges on PFS
  • How can we share learning?
  • How can we collaborate to solve remaining issues?

09:40
Challenges of Developing Prefilled Syringes for a Small/Mid-sized Organization

  • Sachin Dubey Head of Formulation Development, Glenmark Pharmaceuticals

Synopsis

 

  • Overcoming technical and logistic difficulties
  • Assessment criteria’s
  • Choosing right partners – being competitive and attractive

10:10
Morning Refreshments & Speed Networking

Device & Syringe Materials

11:10
The Value of Polymer Syringes and Needle Technology for Sensitive or Viscous Biologics

Synopsis

 

  • A systems design approach to an innovative combination device for a ready to fill polymer based syringe
  • Advantages of polymer syringes including strength, sterilization techniques, silicone oil free technology for reduced aggregation, and manufacturing techniques for low sub-visible
    particulates
  • The value of i-coating™ stoppers, a silicone oil free technology for reduced aggregation
  • Needle technology including 27G thin wall and 29-24G tapered needle technology

11:40
Regulatory CMC and Design Control Considerations for Pre-filled Syringes – Industry Perspective

  • Suzette Roan Associate Director, Regulatory Affairs CMC Combination Products, Biogen Idec

12:10
Modern Syringe Manufacturing – designed by Nipro Pharmapackaging

Synopsis

Laser Cutting – Reduction of Glass Particulate

  • Forming – Process Control
  • automated inspection systems (Camera)
  • Future X-Ray Inspection – needle piercing

12:40
Lunch & Networking

PFS & Device Innovation

14:10
Your Turn-Key Custom PFS Partner

  • Shem Fischer Medical Manager, Contract Manufacturing, Oratech

Synopsis

 

  • Concept/design/prototype
  • Commercialization /scale up
  • Production

14:20
A Novel Class of Device Technologies: Wearable Bolus Injectors for Large Volume Subcutaneous Delivery

Synopsis

 

  • Rationale for large volume subcutaneous delivery
  • Landscape of wearable bolus injectors
  • Requirements of wearable bolus injectors

14:50
User-Centered Design: The Human Factors Perspective

Synopsis

 

  • Defining human factors
  • How human factors guidance documents have emerged in medical devices
  • How to implement the usability Engineering (human factors) process

15:20
Panel: Ensuring Continued Innovation in the Field

Synopsis

 

  • What do patients/healthcare users want
  • Bespoke delivery devices
  • Novel Technologies

15:50
Afternoon Refreshments & Networking

Roundtable Discussions

16:20
Roundtable Discussions

Synopsis

Ensuring Container Closure Integrity

Moderator: Paolo Mangiagalli, Senior Director, Head PFS/ Primary Container Platform, Sanofi

Implications of 21 CFR Part 4 for Pre-Filled Syringe Presentations

Moderator: Suzette Roan, Associate Director, Regulatory Affairs CMC Combination Products, Biogen Idec

Novel Combination Device Technologies

Moderator: Chris Muenzer, Drug Delivery Device Engineer, Roche

Plastic or Glass?

Moderator: Kevin Constable, Director, Technology Development, Terumo

17:25
Chairman’s Closing Remarks

  • Stephen Barat Executive Director, Toxicology, Preclinical Pharmacology , and Bioanalytical Strategy, Actavis

17:30
Poster Session & Networking Reception

Synopsis

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