Latest revision on FDA combination product guidance presented at Pre-Filled Syringes Boston Summit

Posted: 11 January 2017 | | No comments yet

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

Pre Filled Syringes Europe 2017

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

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

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