SMi Reports: Bringing together leading experts in the industry offering insights into device innovations, connected delivery and regulatory guidance for advanced parenteral systems.
In September, SMi’s 2nd annual Pre-Filled Syringes San Francisco Conference will bring together industry leaders and stakeholders, to discuss the latest updates on current device innovations, regulation updates and formulation insights for enhanced PFS Delivery.
Download the brochure to see full agenda and speaker line-up: www.prefilled-sanfrancisco.com/pjpr6
Connected device regulatory considerations and Software as a Medical Device
- An update on the evolving digital health landscape
- An insight into the international regulations for connected devices and harmony of international standards
- Regulations for SaMD and digital apps
- Considerations for data collection for connected devices
George Cusatis, Director, Regulatory Affairs, Merck
How to Use Smart Devices Intelligently to Deliver Outcomes
- Differentiating digital strategies from business objectives
- Why spending the time to form a digital strategy is essential to deliver value with Smart Devices
- How to use Smart Devices and Behavior Design to deliver on key elements of a digital strategy
Jace Blackburn, Smart Device Engineer, Roche/Genentech
Digital technology for continuous improvement of delivery devices
- Software within a Delivery Device: Continuous Improvement Overview
- Artificial Intelligence Goals
- Data Management: What is the value?
- Patient Advocacy
Jim Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
Changes to human factors studies in response to the pandemic
- Identifying whether a study can be run as remote and when is an in-person study needed?
- Process considerations and ensuring reliable remote studies
- Examples, challenges and key takeaways from in-person studies during the pandemic
- Assessing regulatory requirements and can we expect remote studies to continue post-pandemic?
Young Chun, Associate Director – Lead Human Factors and User Research, R&D/Medical Devices Center of Excellence, Takeda
All in the Family – can you make a connected health platform at your company?
- Challenges in developing an in-house connected platform
- Economies of scale or just more to manage?
- Playing nice in the sandbox- managing multiple vendors
- A future outlook of connected health for drug delivery devices
Scott Mullen, Senior Director, Connected Healthcare, Ascendis Pharma
Register online: www.prefilled-sanfrancisco.com/pjpr6
Early bird offer – Register by 30th July and save $200
Sponsored by Almac| Boston Analytical | Zeon | ZwickRoell
#smipfsusa
For all media inquiries contact Jinna Sidhu on Tel: +44 (0)20 7827 6088 / Email: hsidhu@smi-online.co.uk
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk