9:00 am Login & Virtual Networking

9:30 am Chair’s Opening Remarks

The Evolving Regulatory Landscape

9:40 am Keynote: Navigating the Combination Product Regulatory Framework for an Autoinjector

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

10:00 am Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem

• John Schalago Executive Director, Senior GPRD, Novartis

10:20 am Live Q&A – Ask Our Speakers Your Burning Questions

10:50 am Virtual Speed Networking

11:20 am Morning Break

Excellent Device Engineering

11:45 am The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance

• Ophelia Wells Device Development Project Lead, Merck
• Cassie Megna Design Verification Lead, Merck Research Laboratories

12:05 pm The Importance of Device Testing – And Should You Do it In-House?

• Prem Ganapathy Head of Device Testing, Takeda

12:25 pm Live Q&A – Ask Our Speakers Your Burning Questions

1:00 pm Networking Lunch

2:00 pm Digital Health – From Connected Devices to Building a Digital Ecosystem

• Michael Song Head of Device Functionality, Safety, Digital Connectivity, AstraZeneca

Future Injectable Device Strategy

2:20 pm The Future of Electronic-Enabled Combination Drug Delivery Product

• Senior Representative , Philips Medisize, a molex company

2:50 pm Panel Discussion: Incorporating Your User Feedback into Your Device Design & Development to Ensure Smooth Regulatory Approval

• Allison Y. Strochlic Research Director, Human Factors Research & Design, Emergo by UL

3:45 pm Afternoon Break

4:15 pm Make vs Buy (vs Customize): Evidence-Led Device Decision-Making

• Stephen Gilmore Director of Engineering, Crux Product Design

4:45 pm Strategic Platforming: Leveraging Platforms for Combination Product Development

• Tracy Hsu Associate Director, Ionis Pharmaceuticals

5:05 pm Panel Discussion: How to Leverage Human Factors at Every Stage of Combination Product Design

• Joely Gardner, PhD Professor; Chief Researcher, California State Fullerton; Human Factors Research

5:45 pm Chair’s Closing Remarks & End of Day 1

5:50 pm Virtual Happy Hour & Networking