Pre-filled Syringes San Francisco Conference 2021

Memo

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 to give a comprehensive insight into the latest device innovations, regulatory updates and future insights for the coming year. With the global market for prefilled syringes estimated to exceed $9.7bn by 2025, the field is evolving at an exponential rate with connectivity and digital health strategies for devices and studies at the forefront. Furthermore, this event will delve into the key takeaways following the global pandemic and discover how this will be used to enhance future drug delivery device development. This comprehensive overview will explore the changing global market and latest innovations in device design and development for injectable drug delivery. Case studies from leading industry and regulatory experts will explore platform approaches for combination products, enhanced device design and usability considerations, change management and compatibility for novel drug products. The two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more. Plus, two interactive post conference workshops:A: Connected Devices and Digital Health: How to Navigate the U.S. FDA Usability Engineering RequirementsWorkshop Leader: Shannon Clark, CEO, UserWise B: Postmarket Safety Reporting: The Current Regulatory Environment with a Global ImpactWorkshop Leader: Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen Benefits of attending: - Engage in case studies from big pharma leading experts on smart devices and connected delivery to aid the user experience- Explore evolving device design and innovations for high volume and high viscous delivery- Delve into regulatory updates on device development and human factors with insights from industry and regulatory bodies- Uncover how industry is incorporating risk management and controls into early stages for a holistic development process Chairs for 2021:- Shannon Clark, CEO, UserWise- Paul Upham, Head Smart Devices, Roche/Genentech Featured 2021 speakers include: - Alan M. Stevens, Acting Director - Division of Drug Delivery, General Hospital, and Human Factors, CDRH, FDA- George Cusatis, Director, Regulatory Affairs, Merck- James Robert Wise, Associate Senior Consultant Engineer, Eli Lilly- Jim Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals- Scott Surrette, Manager Combination Product Development, Regeneron- Jace Blackburn, Smart Device Engineer, Roche/Genentech- Alasdair Young, Senior Director, Device Engineering, Coherus BioSciences- Rachel Poker, Human Factors Engineering Manager, Device Development, AstraZeneca- Young Chun, Associate Director – Lead Human Factors and User Research, R and D/Medical Devices Center of Excellence, Takeda- Mehak Mehta, Scientist II, Protein Drug Product Development, Biogen- Alie Jahangir, Sr. Principle Engineer, Combination Products and Emerging Technologies, Janssen Pharmaceuticals- Sindhuja Kuchibhatla, Device Development Engineer, New Technologies Management, Regeneron Pharmaceuticals EARLY-BIRD RATES: - BOOK BY 28TH MAY AND SAVE £200- BOOK BY 30TH JUNE AND SAVE £100 Additional Contact Info:T: +44 (0)20 7827 6088E: This email address is being protected from spambots. You need JavaScript enabled to view it.#smipfsusa Date and Time: September 13, 2021 at 9:00 am to September 14, 2021 at 5:30 pm Price: Virtual attendance: USD 999.00