Following argenx’s and Teva’s recent FDA approvals of injectables, the parenteral device engineering community is fuelled with excitements! The rise of high volume, long acting injection, patient centric approach, regulatory requirements such as EU MDR, and increased focus on sustainability are however adding a new set of challenges to device engineering and development teams.
To support your parenteral drug-device combination product with speed-to-market and enhanced patient safety, the 13th Injectables Summit will return to Boston this October, uniting 100+ senior leaders in this field to share lessons learned in the last 12 months, and also together discuss solutions to tackle the urgent challenges and how to incorporate device innovations to elevate your commercial competitiveness.
In collaboration with the likes of Takeda, Sanofi, Gilead, Regeneron, this year’s summit will ensure you walk away with practical tips and set your device program up for success in 2024:
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- BioMarin shares how to ensure approval in Europe for your injectable device by building in MDR considerations from early device development
- Merck helps you understand FDA’s EPR to integrate controls into your device development for a smooth approval process
- AstraZeneca reveals viscosity range, container size and sustainability considerations for next gen platform device to promote injectable device post-launch
- Janssen unveils their ultra high volume subcutaneous device, and how to improve usability of next gen device
- Sanofi, Gilead co-lead a hands on workshop to give you the practical tips on human factors engineering and studies, and consideration of platform approach
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