SMi Launches its 9th Annual Pre-Filled Syringes East Coast Conference
After nearly two years of virtual meetings the industry looks set to meet face to face and have some really important discussions and you are invited to join them.
- (1888PressRelease) December 06, 2021 - SMis 9th Annual Conference
Pre-Filled Syringes East Coast
Main Conference: April 25 - 26, 2022 | Workshops: April 27, 2022
Sheraton Boston Hotel, Boston, MA, USA
www.pfsamericas.com/1888pr1
Sponsors are: SCHOTT, ZEON
Exhibitors: Owen Mumford Pharmaceutical Services, PHC Corporation, POLYPLASTICS- TOPAS, Weiss-Aug Group
Device innovations, connected delivery and regulatory guidance for advanced parenteral systems
The global pre-filled syringes market was valued at $1139.6 million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. With that in mind, the 9th annual Pre-Filled Syringes East Coast conference will bring together leading industry experts representing big pharma and device developers to discuss the key drivers accelerating the expansion of the industry.
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 SMis 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: wwww.pfsamericas.com/1888pr1
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/1888pr1
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
EARLY-BIRD RATES:
BOOK BY 17th DECEMBER AND SAVE $400
BOOK BY 31st JANUARY AND SAVE $200
BOOK BY 28TH FEBRUARY AND SAVE $100
Registrations can be made on the event website at: www.pfsamericas.com/1888pr1
POST CONFERENCE WORKSHOP A: EU MDR 2017/745 Article 117 Requirements
Workshop Leader: Theresa Jeary, Technical Specialist & Scheme Manager, BSi
08.30 - 12.30
Overview of the workshop:
The workshop is aimed to provide an introduction to the key elements of the Medical Device Regulation that Companies affected by article 117 need to consider.
Why you should attend:
Be able to determine if Article 117 is applicable to your products
Understand and be able to interpret the requirements of Article 117
Understand the impacts on your marketing authorization application or post-market variation
Gain an appreciation and understanding of the MDR Annex I, General Safety & Performance Requirements
Understand requirements to facilitate the documentation preparation needed to obtain a NB Opinion
POST CONFERENCE WORKSHOP B: Developing User-Centric Next Generation Combination Products
Workshop Leaders: Marty Coyne, Principal & Co-Founder, Matchstick and Chris Franzese, Principal & Clinical Leader, Matchstick
13.00 - 17.00
Overview of the workshop:
This interactive workshop will explore approaches for developing innovative drug delivery device combination products offering tools for optimal device development with the user in mind. Workshop leaders will provide insights into effectives strategies for concept generation, product testing and validation for the future of device design.
Why you should attend:
Discover innovative concept generation approaches for device development
Understand how to utilise user feedback and experiences in early stages of development
Walk through unique examples assessing effective testing to ensure an optimal product
Engage in interactive discussions to assess opportunities for enhanced devices ensuring the patient is kept at the forefront
Visit the website here to find out more and to download the full agenda: www.pfsamericas.com/
Additional Contact Info:
T: +44 (0)20 7827 6088
E: rjones ( @ ) smi-online dot co dot uk
Follow us: ( @ ) SMiPharm #SMiPFSUSA
www.pfsamericas.com/1888pr1
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