Latest Revision on FDA Combination Product Guidance Presented at Pre-Filled Syringes Boston Summit

FDA Present on Regulatory Considerations for Combination Products at Pre-Filled Syringes East Coast this Spring

Boston, MA, January 13, 2017 --( SMi Group will welcome the expertise of Tina Kiang, FDA Science & Policy Acting Director, when she presents an opening keynote at Pre-Filled Syringes East Coast 2017.

The talk entitled "Regulatory considerations of Combination Products" will explore key topics surrounding applicable regulatory schemes in both the US and EU; the latest revision of the FDA Combination Product Guidance; and changes in FDA’s quality system requirements for pre-filled injection devices.

Working closely with a selection of handpicked PFS experts, the program for Pre-Filled Syringes East Coast 2017 will offer critical updates in pre-filled technological developments and opportunities for both new and established stakeholders.

Other notable speakers joining the FDA on the agenda will include:
· Dhairya Mehta, Associate Director, Shire
· Li-Chun Tsou, Global Device Technical Director, AstraZeneca
· Ronald Iacocca, Research Fellow, Delivery and Device, R&D, Eli Lilly
· Edmond Israelski, Director Human Factors, AbbVie
· David Chen, Principal Scientist, Novel Drug delivery Technologies, Pfizer
· Sudeshna Dutta Ray, Senior Engineer Advanced Device Technology, Amgen
· Stephen Barat, Executive Director, Non-Clinical and Translational Sciences - Safety Assessment and Bioanalysis, Allergan
· Tiffnay McIntire, Human Factors Engineer, Eli Lilly
· Hemal Mehta, Manager, Global CMC-RA, Medical Devices and Combination Products, Janssen R&D
· Phillip Green, Executive Director, Merck
· Michael Selzer, Manager, Combination Products Engineering, Regeneron
· Toshiro Katayama, Product Manager, Zeon
· Kenchiro Usuda, Researcher, Advanced Business Development Division, Mitsubishi Gas Chemical

Further details including a full speaker line-up is available at

Pre-Filled Syringes East Coast 2017
4th Annual Conference: April 26th & 27th
Interactive Workshops: April 25th
The Colonnade, Boston, MA, USA

Sponsored by: FluentaOVLK, Mitsubishi Gas Chemical, MW Industries, Nemera, Overlook Industries, Owen Mumford, Terumo Pharmaceutical Solutions, West Pharmaceutical Services, Zeon

Contact Information:

For all media enquiries contact Teri Arri on Tel: +44 (0)20 7827 6162 / Email:

For delegate enquires contact Fateja Begum on Tel: +44 (0)20 7827 6184 / Email:

To sponsor, speak or exhibit at the conference, contact Alia Malick on Tel: +44 (0)20 7827 6168 / Email:

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
Teri Arri
+44 (0)20 7827 6162