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

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 www.pfsamericas.com/russellpub

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