SMi's 9th Annual Conference Pre-Filled Syringes East Coast

SMi Group25 - 26 April 2022, Boston, MA, USA.
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 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

Early-bird rates

  • 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

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

For further information and to register, please visit:
http://www.pfsamericas.com

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.

Most Popular Now

Pfizer and BioNTech complete submission to Europea…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the European Medicines Agency (EMA) for an Omicron-adapted biva...

Lilly will supply an additional 150,000 doses of b…

Eli Lilly and Company (NYSE: LLY) announced a modified purchase agreement with the U.S. government to supply an additional 150,000 doses of bebtelovimab for approximately...

Bayer to sell men's health product Nebido™ to Grün…

Bayer and Grünenthal have entered into a definitive agreement regarding the sale of Bayer's men's health product Nebido™ (testosterone undecanoate), for a purchase price ...

AstraZeneca to acquire TeneoTwo and its clinical-s…

AstraZeneca announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluatio...

Demonstration of a potent, universal coronavirus m…

The SARS-CoV-2 that causes COVID-19 has killed 6.3 million people worldwide since 2019, painfully highlighting the vulnerability of humanity to novel coronaviruses. Re...

The fourth COVID-19 vaccine reduces the risk of de…

A new study by Tel Aviv University and Ben Gurion University of the Negev, in collaboration with the Israeli Ministry of Health, has found that the fourth COVID-19 vaccin...

Vaccine protection against COVID-19 short-lived, b…

Since COVID-19 vaccines first became available to protect against infection and severe illness, there has been much uncertainty about how long the protection lasts, and w...

Research shows investigational drug fosters nerve …

Scientists from the University of Birmingham have shown that a brain-penetrating candidate drug currently in development as a cancer therapy can foster regeneration of da...

Anti-inflammatory compound shows potential in trea…

An anti-inflammatory compound may have the potential to treat systemic inflammation and brain injury in patients with severe COVID-19 and significantly reduce their chanc...

SARS-CoV-2 hijacks nanotubes between neurons to in…

COVID-19 often leads to neurological symptoms, such as a loss of taste or smell, or cognitive impairments (including memory loss and concentration difficulties), both dur...

Vaccine-induced immune response to omicron wanes s…

Although COVID-19 booster vaccinations in adults elicit high levels of neutralizing antibodies against the Omicron variant of SARS-CoV-2, antibody levels decrease substan...

Scientists develop new biomimetic formulation for …

Glioblastoma multiforme (GBM) is an aggressive brain cancer with a poor prognosis and few treatment options. New and effective approaches for GBM treatment are therefore ...