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
10:00 am Panel Discussion: Putting Your Users in the Designers’ Seat – Enabling Users’ to Lead the Development of Safer & More User-Friendly Injection Devices
10:40 am Live Q&A – Ask Our Speakers Your Burning Questions
10:55 am Virtual Speed Networking
Excellent Device Engineering
11:30 am Morning Break
11:45 am The Development of a New Container Closure Integrity Test (CCIT) for Holistic Evaluation of Prefilled Syringes to Ensure Regulatory Compliance
12:25 pm The Importance of Device Testing – And Should You Do it In-House?
12:45 pm Make vs Buy (vs Customize): Evidence-Led Device Decision-Making
1:15 pm Live Q&A – Ask Our Speakers Your Burning Questions
1:30 pm Networking Lunch
2:00 pm Digital Health – From Connected Devices to Building a Digital Ecosystem
Future Injectable Device Strategy
2:20 pm Balancing Drug Delivery Device Connectivity, Cost, Sustainability & Usability
Synopsis
- Why disposable, single use autoinjectors, introduced in the early 2000s, can no longer satisfy today’s requirements to reduce space, storage, and waste
- The growing demand for drug delivery device connectivity to improve patient adherence, care team collaboration, and health outcomes
- How pharmaceutical companies can create a clear path to low cost connectivity with more affordable, convenient, and sustainable injection devices
- Examples of smart, reusable, autoinjectors that work with mobile apps to track and transmit digital data from patients to physicians
- Key considerations when embracing a connected health platform for biologic and injectable drugs
2:40 pm Smart Device – the FDA’s Thinking of Software as a Medical Device & The Future Ecosystem
3:00 pm Live Q&A – Ask Our Speakers Your Burning Questions
3:20 pm Afternoon Break & Interactive Action Groups
Synopsis
Select the action group topic of choice where you can share your thoughts, questions and challenges with fellow participants following the morning presentations
Digital Devices – From Mechanical to Electromechanical Engineering & Ecosystem | Human Factors & Usability |
4:00 pm Sterility Seal Design for Prefilled Container Closure Systems & Drug Delivery Devices
Synopsis
Current developments in prefilled container closure systems used in drug delivery
systems require removable sterile barriers to connect and establish a fluidic path
for drug delivery at the point-of-use. Therefore, it is essential that next-generation
reusable drug delivery devices utilizing prefilled container closure systems not only
address robust and removable sterility seal component requirements but also simplify
and improve the user experience. This talk will emphasize the advantages and
challenges of current sterility seal technologies and custom seal component design
for a new prefilled container closure system. An introduction to sterile barriers for drug
product container closure systems and specific feature design considerations for sterility
film seals will be given, as well as considerations for elastomer sterility seal design and
development for a novel drug delivery system.