8:00 am Registration & Welcome Coffee

9:00 am Chair’s Opening Remarks

The Evolving Regulatory Landscape

9:10 am Keynote: Navigating the Combination Product Regulatory Framework for an Autoinjector

  • Prasad Peri Senior Director, Regulatory Affairs & CMC, Teva Pharmaceuticals

9:40 am Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem

10:10 am Roundtable Discussion: How to Assess the Evolving Regulatory Framework: From Device Reliability to Extended EU

Synopsis

To kick off the meeting, this roundtable will help introduce you to fellow participants and share recent experiences in meeting regulatory agencies’ expectations in the following topics:

  • Extended deadline – how can we embrace the grace period to get ready?
  • The finer details and impacts on combination products launch in Europe and APAC
  • On-market products vs. emerging combination products – what to prioritize?

We will re-group at the end of this session to feedback for your practical takeaways.

10:45 am Speed Networking & Morning Coffee

Excellent Device Engineering

11:45 am Material Selection & Compatibility of Your Device vs Emerging Biologics – From Stability to Shelf-Life

Synopsis

Reserved for Program Partner

12:15 pm Sterility Seal Design for Prefilled Container Closure Systems & Drug Delivery Devices

  • Murat Gunay Senior Consultant Engineer, Delivery & Device R&D, Eli Lilly

12:45 pm Networking Lunch

1:45 pm The Importance of Device Testing – And Should You Do it In-House?

2:15 pm The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

2:45 pm Panel Discussion: Incorporating Your User Feedback into Your Device Design & Development to Ensure Smooth Regulatory Approval

3:25 pm Afternoon Networking Break

3:55 pm Make vs Buy (vs Customize): Evidence-Led Device Decision-Making

4:25 pm Strategic Platforming: Leveraging Platforms for Combination Product Development

  • Tracy Hsu Associate Director, Ionis Pharmaceuticals

5:05 pm Chair’s Closing Remarks & End of Day 1