Achieving a Patient-Centred PFS Device Through Human Factors with Eli Lilly and Cambridge Consultants

Bringing in voices from some of the most senior industry thought leaders in pre-filled syringes and injectable devices such as Allergan, Pfizer, Sanofi, Novo Nordisk, Amgen, Genentech and Janssen R&D, SMi's 3rd annual conference, “Pre-Filled Syringes – East Coast,” returns to Iselin next April, providing a platform for the industry to discuss pioneering technological developments and address the latest updates in regulation and manufacturing.

Iselin, NJ, December 16, 2015 --( Taking place in New Jersey, USA, day one of the agenda will address topics on regulatory compliance, PFS challenges for complex drugs, human factor evaluation methods and the future of combination products, while day two explores production and manufacturing developments, safety assessment of E&L, plus new technologies for cartridge and needle components.

Driving the quality and commercial competitiveness of patient-centric device design, the featured spotlight on Human Factors (HF), will include a case study from Eli Lilly's Human Factor Engineer, Tiffany McIntire. Focusing on design optimization, the presentation will address questions such as: What are the key considerations in the field of HF? Why are HF evaluation methods necessary? How can user needs drive HF process and demonstrate traceability from requirements to validation outputs?

Human factors will also be the focus in one of the post-conference workshops on April 27th. Hosted by Cambridge Consultants, the session will provide a comprehensive overview of Human Factor considerations in pre-filled syringe delivery devices, instructional material and packaging, as well as offer regulatory guidance to mitigate downstream risks.

Featured speakers in 2016 will also include:
• Stephen Barat, Executive Director, Non-Clinical & Translational Sciences, Safety Assessment & Bioanalysis, Allergan
• Ravi S. Harapanhalli Ph.D., Principal, FDAPharma Consulting LLC -
• Mathias Romacker, Senior Director, Device Strategy, Pfizer
• Dr. Paolo Mangiagalli, Senior Director, Head PFS Platform, Sanofi
• Ken Wong, Deputy Director, MTech/ Process Technology – Extractables & Leachables, Sanofi Pasteur
• Carsten Worsoe, Principal Scientist, CMC Analytical Support, Novo Nordisk A/S
• Dr. Shawn Davis, Principal Engineer, Device Strategy, Amgen
• Mohammed Umar, Principal Technical Manager, Quality Engineering, Genentech
• Jason Lipman, Associate Director, Regulatory Affairs, Medical Devices & Combination Products, Janssen R&D, LLC

For those who are interested in registering, there is currently a $400 early bird saving available online which expires on 18th Dec 2015. Further details are available at

3rd annual Pre-Filled Syringes East Coast Conference and Exhibition
25th - 26th April 2016
Iselin, New Jersey, USA

Sponsored by Mitsubishi Gas Chemical, Nemera, Noxilizer, Terumo Corporation, West Pharmaceutical Services Inc and Zeon

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
SMi Group
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