An update on combination product device development discussed at Pre-Filled Syringes San Francisco 2021

Top Quote SMi Reports: As part of SMi’s leading Injectables series, this year’s event will address the key drivers of the pre-filled syringes and combination products industry. End Quote
  • (1888PressRelease) June 03, 2021 - Delegates stand to gain many valuable insights from Pre-Filled Syringes San Francisco with case studies highlighting developing approaches to device development and strategic platform approaches, design controls and applications and an insight into the evolving landscape of connected devices.

    Visit the event website to learn more and download the brochure at

    An update on combination product and injection device regulatory guidance
    • A review of current guidance for pre-filled syringes and what is new from the past year
    • How has COVID-19 impacted regulatory submissions and processes?
    • An update on expectations for regulatory submissions – common pitfalls and how to ensure you are meeting requirements
    • A future outlook of changes to regulatory requirements and guidance in the coming years
    Alan M. Stevens, Acting Director - Division of Drug Delivery, General Hospital, and Human Factors, CDRH, FDA

    Strategic platforming for combination products
    • Optimising development time, costs and reducing risks through platforming
    • How do you select your platform device and key lifecycle management considerations?
    • Challenges in a one size fits all approach
    • Platforms for novel drug products and new device technologies
    Scott Surrette, Manager Combination Product Development, Regeneron

    Developing on-body delivery devices with the user in mind
    • An outlook on the need for large volume injectors and high viscosity drug products
    • Delivery device technologies for sustained delivery
    • An outlook of evolving delivery devices for novel drug products
    Nicholas Mandala, Senior Director, Medical Device and Combination Product Technology, Pfizer

    Regulatory standards and guidance for combination product Instructions for Use (IFUs)
    • Types of User Documentation
    • Regulatory Requirements for Instructions for Use
    • Special Considerations: accommodating colorblindness, folding, font size
    • Case Study: People with Parkinson’s User Manual Comprehension Research
    Shannon Clark, CEO, UserWise

    Register online:
    Early bird offer register by 30th June and save $100

    Sponsored by | Boston Analytical | Zeon | ZwickRoell

    For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu ( @ ) smi-online dot co dot uk

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