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SMi’s 6th Annual Conference
Pre-Filled Syringes West Coast
June 13 - 14, 2022 | San Diego, CA, USA
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SMi is delighted to announce the 6th annual Pre-Filled Syringes West Coast conference, to be held in San Diego. As part of SMi’s leading series of drug delivery device conferences, the 2022 event will provide insights into the rapidly accelerating market of combination product development with industry, device developer and regulatory perspectives.


The last year has seen major advances in device design and development with patient usability, ease of use and safety remaining at the forefront. This upcoming conference will assess the industry movement towards enabling self-administration through advanced device design, innovations in connectivity to aid the user, and the increasing importance of biologics and novel drug product considerations for device development. Furthermore, regulatory bodies and leaders from big pharma will give an international update on the fast-evolving industry landscape. As one of our most sought-after events, this conference is not to be missed.
 

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.

We look forward to welcoming you to the conference in June.

  • Discover the latest advances in innovative device design for user-centric drug delivery
  • Assess evolving approaches to platforms for advanced combination product portfolios
  • Uncover the key considerations to ensure optimal lifecycle management for drug delivery devices
  • Explore how the industry is evolving with global developments including case studies of sustainable practices for drug delivery devices and the industry’s role in mass vaccination campaigns
  • Engage in interactive sessions reviewing the landscape of on-body injectors for large volume delivery and the role of connectivity for wearable devices

 

• Drug-delivery developers
• Medical Device Engineers
• Primary Packaging material designers
• Secondary packagers
• Smart device developers
• Training device developers
• Device-safety solution providers
• Drug developers

Previous attendees include:


 

 

Abbott Laboratories; AbbVie; Advanced Molding Technologies; Aegerion Pharmaceuticals; Ajinomoto Althea, Inc.; Allergan; Allergen Inc; Almac Group; Amgen; Antares Pharma; Aptar Pharma; AstraZeneca; Baxter Healthcare; BCM Group LLC; BioMarin; Boehringer Ingelheim; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Execution Metrics, Inc; Ferring Pharmaceuticals; Fresenius-Kabi; Genentech; Genentech, Inc.; Gilead Sciences; Glenmark Pharmaceuticals; Harro Hofliger Verpackungsmaschinen GmbH; Inovio Pharmaceuticals; iO Lifesciences; Ionis Pharmaceuticals; Ionis Pharmaceuticals, Inc.; Matchstick; MedImmune; MedImmune LLC; Medizap; Medtronic; Merck & Co.; Mitsubishi Gas Chemical Company, Inc; Nemera; Nipro PharmaPackaging; NOVO Engineering, Inc.; Novo Nordisk; Novo Nordisk A/S; One World DMG; Owen Mumford; Pfenex; Pfenex Inc; Pfizer CentreOne; RAUMEDIC INC; Regeneron; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals, Inc.; Shire; Smithers Rapra; Steri-Tek; Stevanato Group S.p.A; Subcuject ApS; Suttons Creek Inc; Terumo Corporation; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; UserWise, Inc.; W. L. Gore & Associates, Inc.; West Pharmaceutical Services; West Pharmaceutical Services,; West Pharmaceuticals Services Inc; Worrell; Xeris Pharmaceuticals; ZebraSCI; zebrasci inc; ZEON CORPORATION; Zeon Specialty Materials ; Zeon Specialty Materials Inc
 

FEATURED SPEAKERS

Amin Sedighiamiri

Amin Sedighiamiri

Associate Director Device Development, AstraZeneca
Christina Greever

Christina Greever

Sustainability Program Manager, My Green Lab
James P. Wabby

James P. Wabby

Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
Khaudeja Bano

Khaudeja Bano

Executive Medical Director, Head Combination Product Safety, Amgen Inc
Kristina Li

Kristina Li

Sr. Engineer II, Technical Development, Biogen
Larry Atupem

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Natalie Abts

Natalie Abts

Head of Human Factors Engineering, Genentech
Rachel Poker

Rachel Poker

Human Factors Engineering Manager, AstraZeneca
Shannon Clark

Shannon Clark

CEO, UserWise, Inc.
Sriman Banerjee

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
Sujani Nannapaneni

Sujani Nannapaneni

Human Factors Principal Research Engineer, AbbVie
Tina Rees

Tina Rees

Associate Director, Regeneron Pharmaceuticals Inc.

Amin Sedighiamiri

Associate Director Device Development, AstraZeneca
Amin Sedighiamiri

Amin Sedighiamiri has a PhD in Mechanical Engineering with more than 12 years of technical leadership experience, including product innovation and commercialization across multiple industry segments, like medical device, combination product, automotive and water management in Europe and the US. Currently, he is Device Development Engineering Manager in Dosage Form Design and Development organization of AstraZeneca where he is leading combination product development as well as smart drug delivery device technology development projects.

Before joining AstraZeneca, Amin worked as Sr. Engineer in Delivery, Device and Connected Solutions Organization of Eli Lilly and Company, where he led cross-functional teams of engineers to develop connected solutions for drug delivery devices.

He is also Board Member and Technical Programming Committee Chair at Medical Plastics Division in Society of Plastics Engineers.
 

Cecile Gross

Global Category Manager, Nemera services
Cecile Gross

Christina Greever

Sustainability Program Manager, My Green Lab
Christina Greever

Christina is the Sustainability Program Manager for the nonprofit organization My Green Lab where she supports the My Green Lab Certification program, manages the International Laboratory Freezer Challenge, and provides subject matter expertise to the team.
She has been in the laboratory sustainability movement for six years – first as part of the green labs program at the UC Boulder. Now she works to motivate behavior change for greater sustainability at the lab bench.
Christina has held research positions in the fields of molecular biology, behavioral neuroscience, and wildlife conservation, and earned a bachelor’s degree in biology from Lewis & Clark College in Portland, Oregon.

James P. Wabby

Executive Director, Regulatory Affairs - Device/Combination Products, Allergan
James P. Wabby

Over 15 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Nutritional, Cosmetic, Branded Pharmaceutical, Generic, Biologic, Medical Device and Combination Product areas.

Regularly provides Allergan therapeutic franchise units regulatory counsel to all aspects within the quality management system arena pertaining to medical devices and combination products regarding:

  • Regulatory Affairs – CMC Global Dossiers and Device Regulatory Strategy Registrations
  • MDR/IVDR – Person Responsible for Regulatory Compliance 
  • ISO 13485:2016/MDSAP
  • Product Development – Design Controls 
  • Risk Management
  • Human Factors Engineering
  • Acquisitions/Divestitures
  • Import/Export – U.S. Agent
  • CAPA
  • Production Controls
  • Regulatory Inspection Management
  • Materiovigilance 
  • Health-Care Related Laws and International Regulations

Khaudeja Bano

Executive Medical Director, Head Combination Product Safety, Amgen Inc
Khaudeja Bano

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

She is an Abbott President’s award winner, avid Toastmaster and Coach. Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, and AbbVie Inc. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Kristina Li

Sr. Engineer II, Technical Development, Biogen
Kristina Li

Technical lead for life cycle management products at Biogen with 8+ years of medical device design and development experience

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Larry Atupem

Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University.

Natalie Abts

Head of Human Factors Engineering, Genentech
Natalie Abts

Natalie Abts is the Head of Human Factors Engineering at Genentech, where she manages the team that conducts all human factors activities for Genentech’s drug delivery devices. Prior to joining Genentech, Natalie worked in medical device consulting for seven years with the National Center for Human Factors in Healthcare. Natalie has specialized experience in planning and executing both formative stage usability evaluations and validation studies for medical devices and combination products on the FDA approval pathway. Natalie holds a master’s degree in industrial engineering with a focus on human factors and ergonomics from the University of Wisconsin, where she was mentored by Dr. Ben-Tzion Karsh.

Rachel Poker

Human Factors Engineering Manager, AstraZeneca
Rachel Poker

Rachel Poker is an Associate Director, Human Factors, at AstraZeneca, where she has responsibilities leading the incorporation of human factors and a patient- and user-centric mindset from early stage technology development to support for on market products for the biologics and parenteral portfolio.
With 15 years in both device and drug-led combination products across a range of roles in R&D, her experience includes parenteral, inhalation, and ocular drug delivery devices, connected device technologies, and vascular intervention products.
Rachel has a bachelors in Biomedical Engineering from the University of Minnesota and PMP certification from the Project Management Institute

Shannon Clark

CEO, UserWise, Inc.
Shannon Clark

Shannon E. Clark is founder and CEO of UserWise, a consultancy that helps medical device manufacturers and start-ups to design safe and easy-to-use medical devices. The consultants at UserWise conduct usability testing for a variety of medical devices ranging from surgical robots to home-use injection platforms. UserWise consultants also perform safety assessments to comply with U.S. and international regulations related to Human Factors.

Before founding UserWise in 2014, Shannon was a Human Factors Engineer at Intuitive Surgical and Abbott Laboratories.

Shannon graduated from UCLA with a B.S. in Mechanical Engineering and a technical breadth in Technology Management. Shannon is additionally a Certified Professional Industrial Engineer, holds two patents, and has written and published three books.
 

Sriman Banerjee

Head of Packaging Development & CDE, Takeda Pharmaceutical Company Limited
Sriman Banerjee

Sriman Banerjee has over 15 years experience in the field of Plastics & Packaging having worked with Reliance Industries , Marico & Johnson & Johnson. Currently he is working as Head of Packaging Development and Commercial Device Engineering at Takeda and prior to this he was Head of Packaging Development - Respiratory category at Glaxo Smithkline - Consumer Healthcare & co-based out of Switzerland & USA. Sriman is a Mechanical Engineer with a Masters in Packaging from Indian Institute of Packaging and a Post Graduate in Plastic Technology from Indian Plastic Institute. He has also a Masters in Financial Management from Mumbai University. He is a Certified Packaging Professional from IOPP, USA. He is also a Fellow of Indian Plastic Institute. Sriman has presented papers on Plastics technology & Packaging technology in National & International conferences organized by PackExpo, Pharmapack, American Packaging, International Corrugated Conference, PACE, Indian Plastics Institute, AIPMA, Indian Institute of Packaging, India Packaging Show, etc... He has published papers and written articles in South Asia Packaging, IPI Journal, Packaging India, ET Polymers. Etc… He is instrumental in developing many new technologies & applications like PP thermoforming, PP – ISBM, Random co-polymers, Ter-polymers, Spouted pouches, Frenel’s Lens cartons, Unidose packs, etc..… Under his leadership, GSK has been awarded several IndiaStar, Asia Star, Ameristar, WorldStar over the last 6 years & PlastIndia Sustainability award for Excellence in packaging

Sujani Nannapaneni

Human Factors Principal Research Engineer, AbbVie
Sujani Nannapaneni

Sujani Nannapaneni is a human factors engineer at AbbVie within the Combination Product Development group. She has experience across the entire product lifecyle, conducting contextual research, developing and assessing use-related risk assessments, directing formative usability testing evaluations to inform labeling and device design changes as well as designing and executing summative validation evaluations. She has been with Abbott / Abbvie since 2003 in various roles and has been with the Human Factors group since 2013.

Tina Rees

Associate Director, Regeneron Pharmaceuticals Inc.
Tina Rees

Tina Rees is the Associate Director of Human Factors at Regeneron, where she leads a team of human factors engineers that manage all aspects of human factors integration across the development and commercialized platforms. Prior to Regeneron, she also led Human Factors at Ferring Pharmaceuticals and was a Principal Research Scientist in Human Factors at Eli Lilly. She has experience with a wide variety of combination products and medical devices and has participated in a number of submissions resulting in approval of combination products and clearance of medical devices. She received her Ph.D. in Biomedical Research from the Mayo Clinic in Rochester, MN and was a Midwesterner until her move to the East Coast 5 years ago.

Sponsors

Exhibitors

VENUE

Venue to be confirmed

San Diego, USA

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
HOTEL BOOKING FORM

Sponsors


Nemera

Sponsors
http://www.nemera.net

As a world-leading drug delivery device solutions provider, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are a holistic partner and help our customers succeed in the sprint to market of their combination products. From early device strategy to state-of-the-art manufacturing, we’re committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission.

Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions.



Zeon

Sponsors
http://www.zeonex.com

ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media.

They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns.

Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


Exhibitors


Boston Analytical

Exhibitors
http://www.bostonanalytical.com

Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 certified analytical laboratory located in Salem, NH. Boston Analytical provides testing services to Pharmaceutical, Biopharmaceutical and Medical Device companies worldwide including Analytical Testing and Method Development, Microbiological Testing and Environmental Monitoring Services, Biologics, Stability Testing & ICH-compliant Storage, Nitrosamines Testing and Extractables & Leachables Studies.



Owen Mumford

Exhibitors
http://www.owenmumford.com

Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

For more information please visit https://www.ompharmaservices.com/



PHC

Exhibitors
http://www.phchd.com/global/

PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries



ZwickRoell

Exhibitors
http://www.zwickroell.com

ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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