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SMi's 3rd Annual Pre-Filled Syringes West Coast 2018 Conference and Exhibition returns to San Diego on the 4th and 5th of June 2018
Following on from sell-out shows in Europe and Boston, Pre-Filled Syringes West Coast will gather a global audience of medical device experts and PFS industry leaders to discuss new developments and showcase cutting edge advancements, keeping you at the forefront of a booming industry.

The competitive PFS market has sparked great improvements as devices strive for higher quality, safety, and patient satisfaction. Innovation and excellence is requested at every level, making Pre-Filled Syringes West Coast the perfect platform to strengthen knowledge in key principles such as human factor engineering, manufacturing in the landscape of complex biologics, whilst honing in on emerging trends for parenteral devices, in the remit of quality controls, intellectual property and advances in drug-delivery designs including auto injectors, pens, pumps and smart devices.

Hear from a selection of carefully handpicked keynote addresses and case studies presented by big pharma as well as leading industry KOL's including Mitsubishi Gas Chemical, Nemera, Terumo Pharmaceutical Solutions, West Pharmaceutical Services, Zeon + more!
 

“It is critical to develop working relationships and collaborations, as an industry, to bring knowledge to the suppliers and drug developers worldwide, so that we can address these challenges. Thank you to everyone who contributes to this goal and looking forward to your participation at the conference." - 2017 Speaker and Conference Chair: Mike Stelmah, Senior Manager, Combination Products Regulatory Affairs, Regeneron



 

Join us in San Diego to

  • Explore and harness the global regulatory ecosystem; global compliance requirements for product safety and risk analysis
  • Assess quality control systems and risk based control strategies for combination products
  • Map the importance of Human factors and patient centricity in device design
  • Highlight the emerging trends of connected health and the future of drug delivery device designs
  • Cutting edge industry insight on manufacturing processes and techniques, from formulation to fill, to secondary packaging and distribution 
  • Please contact Abigail de Vries (adevries@smi-online.co.uk) for further details on participating in this years sell-out show!

 

Executives, Directors, VPs, Heads, Principals, Managers of:

  • Pre-Filled Syringes/ PFS
  • Autoinjectors
  • Device/ Device Engineering
  • Human Factor
  • Scientist
  • CMC
  • Product
  • Injectables
  • Sterile Manufacturing
  • Packaging
  • Regulatory Affairs

or anyone who works with Pre-Filled Syringes/ Autoinjectors within pharmaceutical, biotech and solution providers.

 

Abbott Laboratories; Alkermes; Allergan; Amgen; Anteris Medical GmbH; Baxalta; Baxter Healthcare; Bayer Healthcare; Bayer HealthCare AG; BCM Group LLC; Biogen Inc; Boehringer Ingelheim; Boehringer Ingelheim Pharmaceuticals Incorporated; Bosch Packaging Technology; Bristol-Myers Squibb Co; Cambridge Consultants Ltd; Centurion Medical Products; DDL; Eli Lilly ; Emergent BioSolutions Inc.; ENCO Pharmaceutical Development, Inc. (EPDI); Epione BioPharmaceuticals; FDA; Genentech; Genentech, Inc.; Getinge A B; Gilead Sciences; Gilead Sciences Inc; Insulet Corp; IntraCellular Therapies Inc; Ionis Pharmaceuticals, Inc.; KBI Biopharma; LoneStar Heart Inc; Maeda industry Co Ltd; Merck, Sharp & Dohme Corp.; MITSUBISHI GAS CHEMICAL COMPANY, INC; Mitsubishi Gas Chemical Singapore Pte Ltd; Noxilizer, Inc.; PAREXEL International; Pfizer; Pfizer CentreOne; Pharmacircle; Shire; Shire US Inc; Steris Corp; STERIS FINN-AQUA; Takeda Pharmaceuticals; Teleflex; Terumo Americas Holding, Inc; Terumo Medical Corporation; Terumo Pharmaceutical Solutions; Teva Pharamceuticals; Teva Pharmaceuticals; UserWise; Versartis, Inc.; W.L. Gore & Associates, Inc.; Xcelthera; Xeris Pharmaceuticals; Xeris Pharmaceuticals, Inc.; ZebraSCI; zebrasci inc; Zeon Chemicals L.P.;

FEATURED SPEAKERS

Arnaz Mahli

Arnaz Mahli

Associate Director / Device Development Lead, Shire
Darin Oppenheimer

Darin Oppenheimer

Executive Director, Head Drug Device Centre of Excellence, Merck
David Post

David Post

Director Science and Technology, AbbVie
Edmond Israelski

Edmond Israelski

Consultant - Technical Advisor on Human Factors, AbbVie
Maria Toler

Maria Toler

Quality Portfolio Support and Innovation-Drug Delivery Systems and Medical Devices, Pfizer
Michael Song

Michael Song

Sr. Manager, Drug Delivery and Device Development, MedImmune
Paul Upham

Paul Upham

Senior Principal, Genentech
Tina Rees

Tina Rees

Associate Director-Human Factors, Ferring Pharmaceuticals

Adrien Tisserand

Category Manager - Parenteral, Nemera
Adrien Tisserand

Arnaz Mahli

Associate Director / Device Development Lead, Shire
Arnaz Mahli

Arnaz has 15 years of experience in the medical devices and combination products. He currently works at Shire Pharmaceuticals in Lexington, MA focusing on Device Strategy and Technology Development. Prior to Shire, he led cross-functional development teams from pre-concept through pilot production at OmniGuide Surgical. He also led product and technology development initiatives at Covidien/Medtronic. Arnaz holds 15 U.S. patents and is a Six Sigma Black Belt. He received his Master’s degree from UMass Amherst in Mechanical Engineering. He has authored over 10 publications on topics ranging from mechanical behavior of polymers and utilizing vibration to forecast machine failures.
 

Darin Oppenheimer

Executive Director, Head Drug Device Centre of Excellence, Merck
Darin Oppenheimer

Dr. Darin S. Oppenheimer is an Executive Director of the Drug Device Center of Excellence focusing on Medical Devices and Combination products at Merck based in Upper Gwynedd, PA.

Darin is involved in many facets of the Product Development Lifecycle including regulatory submissions, due dili¬gence, and active participation on industry trade organizations and standards committees. His prior background as a Research and Development Scientist focused on pharmaceuticals and medical device diagnostic applications for biomarker and drug discovery.

Darin’s undergraduate degree is in Molecular Biology from the University of Tampa. He also holds two Masters Degrees from Johns Hopkins University in Biotechnology and Regulatory Science as well as a graduate Certificate in Biotechnology Enterprise. Recently Darin has completed his Doctorate degree in Regu¬latory Science from the university of Southern California.
 

David Post

Director Science and Technology, AbbVie
David Post

David Post, Ph.D., is a Director in Operations Science and Technology Combination Products. In this role, he is responsible for technical operations support of on market autoinjectors with a focus on Humira, continuous improvement projects and analytical method development. Additionally, he is a technical lead for transfer of new combination products from R&D to operations with a focus on Biological Combination Products. David Joined Abbott/Abbvie in 1991. He earned his bachelor's degree in Biochemistry from the University of Wisconsin-Madison and his Ph.D. in Biochemistry from the University of Illinois Urbana-Champaign.

Edmond Israelski

Consultant - Technical Advisor on Human Factors, AbbVie
Edmond Israelski

Ed Israelski PhD, consultant, is retired director of human factors at AbbVie, since 2001, where he led a cross-division team and managed an R&D group to imbed best-practice human factors engineering HFE design methods into all of AbbVie's products, to ensure safety and usability. He was responsible for corporate HFE policies and guidances and internal HF education. He is past co-chair of the Human Factors Committee for the AAMI Standards organization and co-convener of the medical device Usability Engineering groups for the international standards organizations ISO and IEC. He is a board Certified Human Factors Professional and a Fellow of the Human Factors and Ergonomics Society.

Joke Maes

Product Manager, Terumo Pharmaceutical Solutions
Joke Maes

Maria Toler

Quality Portfolio Support and Innovation-Drug Delivery Systems and Medical Devices, Pfizer
Maria Toler

Maria has worked in the pharmaceutical industry for over 25 years. She is currently a Sr. Manager in the Quality Assurance-Drug Delivery Systems and Medical Devices group at Pfizer. She is responsible for developing quality systems and ensuring compliance to regulations that apply to new drug delivery technologies such as medical devices and combination products. She has held a variety of roles over the years including analytical and formulation sciences for both small and large molecules. Her area of expertise is in particle and materials characterization, including trace analysis (particle identification). She has a Master’s of Science in Pharmaceutical Chemistry from the University of Kansas, Lawrence KS.

Michael Regn

Director, Packaging Design and Development, Allergan
Michael Regn

Michael serves as Director, Packaging Design & Development and is the head of packaging at Allergan’s R&D Center of Excellence in Irvine, CA. His organization is responsible for developing packaging solutions across pharmaceutical, biological, and medical device businesses – this includes topical, injectables, oral, and inhalation dosage forms. Michael is also a CMC team leader for a late-stage development program (drug-device combination), and led design control efforts across different combination products in addition to providing technical leadership and strategic insight. Prior to joining Allergan, Michael spent 7.5 years supporting product development and manufacturing at Hospira (now Pfizer) and Schott – he also held roles of increasing resonsibility at Merck, Eli Lilly, Novo Nordisk, and Amgen. Michael earned an MSc degree in Chemical Engineering from New Jersey Institute of Technology.

Michael Song

Sr. Manager, Drug Delivery and Device Development, MedImmune
Michael Song

Michael Song is the head of Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his current role, he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; container closure integrity; and digital connectivity for biologic products. Prior to his current role, Michael was head of Device and Package Engineering department at Adello Biologics. He also has held key engineering and toxicology SME positions at Stryker and Kavlico, a member of Schneider Electric. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Molly Larson-Wakeman

Lead Clinical Analyst, Matchstick
Molly Larson-Wakeman

Paul Upham

Senior Principal, Genentech
Paul Upham

Paul is a Senior Principal at Roche / Genentech where he leads the Smart Device Technology Center. Paul has 20 years of experience in medical device R&D, strategic marketing, product management, clinical research, and medical informatics.
Prior to Roche / Genentech, Paul was with Becton Dickinson(BD), as Worldwide Director of Strategic Marketing in their Pharmaceutical Systems business. Paul and his team were responsible for all upstream and downstream marketing strategy for BD's self-injection business, including pen injectors, autoinjectors, and wearable patch injectors.
Prior to that role, Paul was with WellDoc, Inc. as Director of Product Marketing, where he built and led the marketing team and was responsible for product management activities for WellDoc’s portfolio of mobile health solutions. He was also the Core Team Leader for WellDoc’s landmark BlueStar™ product, a class II medical device and the world’s first reimbursed, prescription-only software for type 2 diabetes.
Paul’s prior experience includes 10 years at BD in the Diabetes Care business. Paul was responsible for the development and launch of the award-winning BD InterActiv® Diabetes Software, and was a member of the joint BD / Medtronic core team that launched ParadigmLink®, the world’s first wireless blood glucose meter.

Paul holds two issued patents in medical software and drug delivery devices and multiple patent applications covering software and medical devices. He is also an author and co-author of numerous peer-reviewed articles in medical informatics and in diabetes. His education background includes undergraduate studies in cognitive science and graduate work in health informatics and finance at the University of Minnesota and New York University.
 

Shota Arakawa

Researcher , Mitsubishi Gas Chemical
Shota Arakawa

Mr. Shota Arakawa is a researcher of Advanced Business Development Division.
He gained a Diploma in Science in 2007 and a Master Degree of Science in 2009 from Osaka University.
Since April 2009 he has been working for Mitsubishi Gas Chemical Company, Inc.
and in charge of macromolecular science, especially in synthesis of polymers and material development.
Since 2012 he has joined a development team of multilayer plastic vial & syringe for biologics.
 

Tina Rees

Associate Director-Human Factors, Ferring Pharmaceuticals
Tina Rees

Tina Rees is the Associate Director of Human Factors at Ferring Pharmaceuticals, where she is responsible for the development and implementation of Human Factors and Usability Engineering processes into the overall product development process. Prior to her move to Ferring, she was a Principal Research Scientist in Human Factors at Eli Lilly, focusing on human factors usability within the diabetes division. She has conducted many formative and summative usability studies and has participated in a number of submissions to regulatory authorities resulting in clearance of medical devices and approval of combination products. She is a strong proponent of human centered design processes and incorporating human factors early into the device development process.

Torsten Vilkner

Senior Associate Director, Manufacturing Operations, Boehringer Ingelheim
Torsten Vilkner

Toshiro Katayama

Product Manager, ZEON
Toshiro Katayama

Sponsors and Exhibitors

VENUE

Crowne Plaza San Diego

2270 Hotel Circle North, San Diego, CA, USA

Sponsors and Exhibitors


Almac Group

Sponsors and Exhibitors
http://www.almacgroup.com

Almac Group is an established, leading contract development and manufacturing organisation providing an extensive range of integrated services to over 600 pharmaceutical and biotech companies globally. Its Pharma Services Business Unit offers services including pharmaceutical product launch & distribution, commercial drug product manufacture, commercial packaging, serialisation, commercial storage & distribution, and early and late phase pharmaceutical development. The privately owned, global organisation has grown organically for 50 years now employing in excess of 5,000 highly skilled personnel and has a strong reputation for innovation, quality and exceptional customer service. The Group is headquartered in Craigavon, Northern Ireland with additional operations based throughout Europe, US and Asia.


CSS (Connecticut Spring & Stamping)

Sponsors and Exhibitors
http://www.ctspring.com

CSS (Connecticut Spring & Stamping) is a customer-focused, engineering driven company with a 75 year track record of success. We engineer and manufacture precision metal springs, stampings, metal forms and assemblies, especially for the medical device industry. Our experience ranges from auto-injectors and infusion devices, to surgical instruments and sensors. CSS facilities are ISO 13485 certified. Leading OEMs and contract manufacturers partner with CSS for consistent volume production.


Mitsubishi Gas Chemical

Sponsors and Exhibitors
http://www.mgc.co.jp/

Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


Nemera

Sponsors and Exhibitors
http://www.nemera.net

NEMERA is a world leader in the design, development and manufacturing of drug delivery solutions for pharmaceutical, biotechnology and generics industries. Nemera’s expertise covers several modes of delivery: Parenteral, Nasal, Buccal, Auricular, Ophthalmic, Pulmonary, Dermal and Transdermal. Nemera leverages decades of experience in the parenteral device segment from full development to pure contract manufacturing, through customized solutions. Nemera developed: Safe’n’Sound®, a fully passive safety device for prefilled syringes to avoid accidental needle-sticks. Safelia®, a new generation of 2-steps auto-injector for fluid and viscous formulations.


Owen Mumford

Sponsors and Exhibitors
http://omdevicesolutions.com

Owen Mumford offer an integrated design and build service from a broad base of proven self-injection and blood-sampling platform devices and intellectual property. Find out more at omdevicesolutions.com or contact us at devicesolutions@owenmumford.co.uk


Steri-Tek

Sponsors and Exhibitors
http://www.steri-tek.com

Steri-Tek is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries. Steri-Tek is a ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed facility. Particularly with sensitive materials and complex devices, Steri-Tek has developed a proprietary system for optimizing E-beam/X-Ray sterilization of drugs/biologics in combination devices, pre-filled syringes, implantables, bioabsorbables and other complex products.


Terumo Pharmaceutical Solutions

Sponsors and Exhibitors
http://www.terumo-ps.com/

Terumo Pharmaceutical Solutions offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specific requirements.


West Pharmaceutical Services, Inc.

Sponsors and Exhibitors
http://www.westpharma.com/

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2016 net sales of $1.5 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.


ZEON

Sponsors and Exhibitors
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.

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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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