Press release
Device innovations, connected delivery and regulatory guidance for advanced parenteral systems
Pre-filled Syringes East Coast
The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. As part of SMi’s leading injectable series, the 2022 conference will provide an exclusive insight into the latest developing technologies for device design, advances in parenteral device platforms and development, insights into growing integration of digital health and deep dives into recent case studies on novel delivery systems.
This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.
Visit the website at: www.pfsamericas.com/
Chair for 2022:
Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs – Devices and Combination Products, Takeda
Guest FDA Speaker:
• John Barr Weiner, Associate Director for Policy and Product Classification Office, Office of Combination Products FDA
Featured 2022 Speakers Include:
• Joyce Zhao, Associate Director, Combination Product, Takeda
• Suzette Roan, Associate VP and Head of Global Device Regulatory Affairs, Sanofi US
• Christine lynn lanning, Distinguished Scientist, Device Area Leader, Merck
• Heather l. Guerin, Associate Director, Regulatory Affairs – CMC, Janssen
• Tieming Ruan, Senior Director of Device Development, Alexion Pharmaceuticals
• John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
• Gretchen Piwinski, Manager, Combination Product Laboratories, Regeneron
• Michael Song, Associate Director, Takeda
• Deep S Bhattacharya, Senior Scientist, Drug Product Development and Design, Pfizer
BENEFITS OF ATTENDING:
• Explore the latest developments in innovative technologies for device design accelerating the path to self-administration
• Assess the evolving regulatory landscape for pre-filled syringes and discuss approaches to work with regulators as guidance is updated
• Engage in panel discussions with industry leaders to navigate the accelerating digital health landscape for combination products and drug delivery systems
• Understand the landscape of delivery for novel drug products and key considerations to overcome challenges in CCI
View the full agenda and speaker line-up online: www.pfsamericas.com/
Who should Attend:
• Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers
Registrations can be made on the event website at: www.pfsamericas.com/
SMi Group Ltd Registered & Head Office Ground Floor, London SE1 2ND
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 http://www.smi-online.co.uk
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