Building on the success of previous sell-out shows, SMi Group is delighted to announce the return of the 6th annual conference and exhibition: Pre-Filled Syringes - East Coast, taking place on April 8th – 9th April in Boston, Massachusetts, USA.
Pre-Filled Syringes East Coast will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the pre-filled industry, helping attendees to secure global success for their devices.

PROGRAMME HIGHLIGHTS:

• Explore the outcomes of the EU Medical Device Regulations (MDR) and the impact of these changes on the industry
• Evaluate key aspects of partnering, outsourcing and translation of market research for successful commercialization
• The 21st Century Cures Act: defining the device
• Learn different approaches to summative human factor validation studies
• Chemical compatibility challenges and the resulting impact on drug delivery performance
• Device design strategies for successful implementation of connected devices
• Forecasting the future of pre-filled syringes with consideration of competitive drug delivery systems

SPEAKERS INCLUDE:

• Molly Story, Head of Global Usability Engineering and Risk Management, Sanofi
• Linda Ricci, Associate Director for Digital Health, Office of Device Evaluation, FDA
• Nicholas Zampa, Senior Engineer, Human Factors and Risk Management, Biogen
• John Schalago, Head Devices, EMD Serono
• Cedric Gysel, Health Care Solutions Design Manager, Johnson & Johnson Design
• Joyce Y Zhao, Device Lead, Combination Product Development, Takeda
• Michael Song, Sr. Manager, Drug Delivery and Device Development, MedImmune
• Amit Khanolkar, Director, New Product Development Quality Engineering, Janssen
• Ramin Samadani, Senior Scientist in Dosage, Form, Design and Development, MedImmune
• Hemal Mehta, Associate Director Global CMC RA, Medical Devices and Combination
• Products, Janssen Ling Lu, Sr. Principal Scientist, Pfizer
• Brian Frank Lewis, Senior Consultant Engineer, Eli Lilly
• Tina Kiang, Acting Division Director, CDRH/ODE/DAGRID, FDA

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