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Pre-Filled Syringes West Coast
June 4 - June 5, 2018
Pre-Filled Syringes West Coast

SAE Media Group's 3rd Annual Conference and Exhibition
Pre-Filled Syringes West Coast
June 4 - 5, 2018 | San Diego

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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



 

FEATURED SPEAKERS

Arnaz Malhi

Arnaz Malhi

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, Retired Director of HF, 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
Torsten Vilkner

Torsten Vilkner

Senior Associate Director, Manufacturing Operations, Boehringer Ingelheim

Adam Kalbermatten

Director or Marketing, Terumo Medical Corporation
Adam Kalbermatten

Adam Kalbermatten serves as Global Director of Marketing at Terumo. He is responsible for overseeing the Terumo Pharmaceutical marketing team that develops and markets drug delivery devices and combination products to meet the unique needs of pharmaceutical companies. Prior to joining Terumo in 2015, Adam held various operations and commercial leadership roles at both Becton Dickinson (BD) and Merck. Adam holds a Bachelor of Engineering in Mechanical Engineering and a Masters of Engineering in Engineering Management from Stevens Institute of Technology and a MBA from Columbia University.

Arnaz Malhi

Associate Director / Device Development Lead, Shire
Arnaz Malhi

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.
 

Carl Dabruzzi

Senior Manager, Product Management, West Pharmaceutical Services, Inc.
Carl  Dabruzzi

Carl Dabruzzi has over 20 years of experience in the pharmaceutical and drug delivery industries. He joined West Pharmaceutical Services in 2017 as a Senior Manager in the Product Management organization. His primary responsibilities are to manage the development and commercialization of West’s portfolio of Self-Injection Systems. The portfolio includes the SmartDose® platform of wearable on-body infusors and the SelfDose™ injector. These devices are marketed through West’s Biologics, Pharmaceuticals and Generics business units.

Prior to joining West, Carl worked in the Pharmaceutical and Drug Delivery Systems divisions of 3M. He has an extensive background in respiratory and transdermal drug delivery systems that includes biological research of new chemical entities, analytical development and validation, regulatory affairs, account management, portfolio management and strategic business development. Carl holds a B.S. in chemistry from the University of Wisconsin in River Falls.
 

Chris Franzese

Lead Clinical Analyst, Matchstick
Chris Franzese

Chris Franzese is Clinical Leader at Matchstick. He manages a team of clinicians supporting client projects related to combination product and medical device development and usability testing, leads the company’s clinical training, and is accountable for making clinical knowledge accessible and relevant to client projects. An experienced clinical trial researcher, Dr. Franzese has numerous peer-reviewed publications related to usability research for connected medical devices, antiplatelet therapies in coronary artery disease, and clinical laboratory testing. He has a BS in Biology from Loyola University, an MHS in Health Informatics and a PharmD both from Fairleigh Dickinson University. He is a licensed pharmacist.

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.

Debbie McConnell

Human Factors Manager, Worrell
Debbie McConnell

A seasoned veteran with over 25 years of experience working with product development teams, Debbie has spent the last 13 years leading complex human factors programs through all the phases of the product development life cycle including early ethnographic research, design iteration, prototyping, development and validation, launch support and post-market surveillance. As Human Factors Manager, she works on many devices across both medical device and pharma, including drug delivery/combination products, complex surgical robotics systems and neuromodulation systems. She holds a ME in Instructional Technology and is a Certified Usability Analyst.

Edmond Israelski

Consultant - Technical Advisor on Human Factors, Retired Director of HF, 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.

Juan Ernesto Rodriguez

Head of Business Development, iO Lifesciences
Juan Ernesto Rodriguez

Julian Jazayeri

Senior Engineer , Amgen
Julian Jazayeri

Julian Jazayeri is a senior engineer at Amgen. He is based out of the container science and engineering group and focuses on mechanical characteristics of primary containers and drug delivery device integration. Julian earned a BS in mechanical engineering from the California Polytechnic State University of San Luis Obispo in 2012. Before joining Amgen, Julian was involved in developing injection molds for medical device components and processes. Since 2011, Julian has been heavily involved in the development of drug delivery systems of biotechnology products.

Kate Stephenson

Academic Partnerships and Business Development, iO Lifesciences
Kate Stephenson

Larry Atupem

Sr Business Development Specialist, ZEON
Larry Atupem

Larry Atupem is the Sr. Business development specialist at Zeon Specialty materials with responsibility for development and marketing of Cyclic Olefin Polymer business in North America. 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 along with management business coursework from Boston University.

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.

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.
 

Ron Forster

Executive Director, Device & Final Drug Product Technologies, Amgen
Ron Forster

Dr. Forster is the Executive Director, Device Final Drug Product Technology department at Amgen Inc. Responsible for all Container Closure Systems, their integration into combination products, devices and drug substance systems. His team has developed and published numerous standards for Biological Packaging systems, led multi-company teams to establish guidance’s in Biological Packaging development, and serves on numerous customer advisory boards for packaging suppliers.

He is also a Board of Director member as well as head of the Technical Advisory Committee for the Suzhou Industrial Park Biologics and Pharmaceutical Packaging institute (Upon accreditation this facility will become the Chinese National Biological Packaging Testing Laboratories)


Prior to joining Amgen, Ron was with Merck Inc. where he was Senior Principle Engineer leading a group that implement Quality by Design for primary packaging systems from early clinical development through commercial supply chain systems. He was a key leader in advancing the Merck Commercialization process and served as a global manufacturing lead on a key product franchise board.

During his tenure at Merck, he also served as an Adjunct Professor at Rutgers University in Biomedical Engineering and Ceramic Engineering.

Ron has an Interdisciplinary Ph.D. from Rutgers University in Chemical Engineering, Ceramic Engineering, and Mechanics and Materials Science.

Royce Brockett

Director, Product Management, West Pharmaceutical Services, Inc.
Royce Brockett

Royce Brockett has 16 years of experience working in the pharmaceutical industry with a focus in sales and marketing. He is currently the Director of Prefilled Systems & Delivery at West Pharmaceutical Services. His responsibilities include supporting business development efforts, defining new products, and executing marketing strategies. Royce has published articles related to sterilization techniques for elastomer components, particle reductions strategies, and cartridge technology. Prior to joining West, Royce held various positions within the sales and marketing organization at AbbVie, Solvay, and Pfizer. Royce holds a BS in biochemistry from Lehigh University and an MBA in Health Sector Management from Boston University.

Severine Duband

Global Category Manager Parenteral, Nemera
Severine Duband

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

After his undergraduate studies of Pharmacy at the University of Greifswald, Germany, Torsten moved to London, UK to conduct his postgraduate studies by developing novel, miniaturized solutions to the old problem of pharmaceutical powder mixing. He obtained his PhD from Imperial College London in 2005. Torsten then started his career with Boehringer Ingelheim working in the Corporate Quality Department for 1 year. For the next 9 years he held several positions within the commercial manufacturing organization, especially focusing on production, validation and supply-chain management of inhalation product. In 2016 he got the opportunity to move to California with his family and to gain experience in Boehringer Ingelheims biopharmaceutical production site in Fremont. Currently he is Senior Associate Director Fill & Finish Operations within the manufacturing department.

Veneza Yuzon

Engineer , Amgen
Veneza   Yuzon

Veneza Yuzon is an Engineer in the Container Science and Engineering department at Amgen, where she focuses primarily on qualifying primary container systems to support the development and verification of combination products. Prior to joining Amgen, she has worked as a product development engineer in the medical device industry, designing and developing orthopedic devices and surgical torque wrenches. Veneza holds a BS in Bioengineering from the University of California, San Diego.

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Ron Forster, Executive Director, Device & Final Drug Product Technologies, Amgen

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9:10

Facing the challenges of biopharmaceutical manufacturing in the PFS industry

Torsten Vilkner, Senior Associate Director, Manufacturing Operations, Boehringer Ingelheim

  • Understanding the product life cycle for biopharmaceuticals
  • Technology transfer and Validation and new product licensure in the PFS
  • Boehringer-Ingelheim’s flagship biopharmaceutical manufacturing facility start-up
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    9:50

    Making the economic case for Human Factors Engineering for medical products: Examples of Rate of Return on HFE Investment

    Edmond Israelski, Consultant - Technical Advisor on Human Factors, Retired Director of HF, AbbVie

  • Understand dimensions of the benefits of Human Factors Engineering for medical devices
  • Types of business cases to show economic benefits of HFE
  • Examples of calculations for Return on Investment, Rate of Return and payback period
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    10:30

    Morning Coffee Sponsored by ZEON

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    11:00

    Pairing advances in drug development with advances in drug delivery

  • Ensuring consistency of injection time for drug products >2mL
  • Strategic drug delivery options for drugs of higher viscosity
  • Implications of complex dosing requirements and patient compliance
  • Carl Dabruzzi, Senior Manager, Product Management, West Pharmaceutical Services, Inc.

    Royce Brockett, Director, Product Management, West Pharmaceutical Services, Inc.

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    11:40

    Navigating injection technologies for reliable incorporation between drug and packaging: the design life-cycle

    Michael Regn, Director, Packaging Design and Development, Allergan

  • Considering the challenges at the interface of formulation and primary packaging
  • Incorporating patient centricity into the development process
  • Preparing for a successful launch and ensuring a lasting post-approval legacy
  • Leveraging tools to improve outcomes and promote a design culture
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    12:20

    Networking Lunch Sponsored by West Pharmaceutical Services

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    13:20

    Leveraging preformative research to inform lifecycle management of combination products for complex disease states

  • Empathizing with total disease burden for complex disease states
  • Challenges of managing drug delivery (use steps) from patient perspective
  • How to identify opportunities to reduce complexity for patients
  • Two case studies (Hemophilia and Primary Immunodeficiency Disease)
  • Adam Kalbermatten, Director or Marketing, Terumo Medical Corporation

    Chris Franzese, Lead Clinical Analyst, Matchstick

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    14:00

    Design of a combination product for manufacturability

    David Post, Director Science and Technology, AbbVie

  • Identifying critical processes in design
  • Implications to scale up
  • Lifecycle of design improvements
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    14:40

    How can injection devices influence positively the patients’ experience and the pain perception

    Severine Duband

    Severine Duband, Global Category Manager Parenteral, Nemera

  • Pain perception: mapping of main parenteral factors
  • Device impacts
  • Drug impacts
  • User impacts
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    15:10

    Afternoon Tea Sponsored by ZEON

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    15:50

    Container and Closure Integrity Testing (CCIT) - Options, approaches, and future trends

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

  • Maintaining container closure integrity during manufacturing and product shipping
  • Container Closure Integrity test methods and appropriate applications
  • Optimizing and developing novel methods to meet new challenges
  • Approach to detecting container closure integrity for complex drug delivery devices
  • Applying CCIT approaches to determine container closure integrity during high altitude shipping
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    16:30

    Design of a connected device ecosystem

    Paul Upham, Senior Principal, Genentech

  • Identifying the strategic drivers
  • Defining the unmet needs
  • Creating a platform framework
  • Delivering hardware and software technologies
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    17:10

    Impulse Pressure Waves: Understanding the First Milliseconds of Device Activation

    Julian Jazayeri , Senior Engineer , Amgen

  • Large molecule drug product development trends are moving to high concentration and high viscosity products
  • Current available delivery technologies struggle with maintaining injection time regulatory requirements with high viscosity products
  • High powered delivery systems can impart highly transient events and forces which can result in component failure
  • Device development for delivery high viscosity products' need to consider dynamic system
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    17:50

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

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

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    9:10

    Challenges of Pre-Filled Syringes in a regulated combination product environment: A cross-border perspective

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

  • What are the challenges manufacturers face today?
  • What challenges are on the horizon for pre-filled syringes in the EU and US?
  • What can we do to prepare for upcoming unique challenges and opportunities in this space?
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    9:50

    Bringing It All Together – The Design History File

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

  • Creating Design History Files for less and more complex combination products
  • The Design History File from early development to commercial
  • Addressing human factors / usability throughout the product lifecycle
  • Challenges in later stage development and post market Design History File maintenance
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    10:30

    Morning Coffee Sponsored by ZEON

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    11:00

    Early-stage device development: Challenges and opportunities

    Arnaz Malhi, Associate Director / Device Development Lead, Shire

  • Engage with product teams (clinical and commercial) early to identify unmet needs and opportunities for delivery related innovation
  • Tools such as Target Device profile and User Research help drive alignment
  • Identify critical technology risks and focus on proving feasibility
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    11:40

    Technical update - ZEON/ZENOR, Cyclo Olefin Polymers for Pre-Filled Syringes

    Larry Atupem, Sr Business Development Specialist, ZEON

  • Key properties and features of COP and its benefits for pre-filled syringe applications
  • Mechanical properties after exposure to gamma, steam, EOG and cryogenic temperature
  • JP, US, EU Pharmacopoeia and ISO 10993 status
  • Extractables/leachable test data in COP syringes with various chemicals
  • Protein adsorption/aggregation study data with actual protein drugs to COP vs. glass
  • Delamination study data on glass syringe
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    12:20

    Networking Lunch Sponsored by West Pharmaceutical Solutions

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    13:20

    Transitioning syringe system qualification process to incorporate design verification deliverables upfront, to better integrate with combination product requirements

    Veneza Yuzon , Engineer , Amgen

  • Eliminating duplicate or redundant work by identifying parallels between qualification process and verification process
  • Qualification / verification hybrid - allows for the verification of the base platform container requirements as defined by industry requirements (i.e. ISO and pharmacopeia), whilst still ensuring the container is suitable for use in manufacturing and / or product specific applications
  • Verification of a platform container systems subassembly, to fit into a "modular" platform combination product DHF
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    14:00

    Extractables and stability studies of OXYCAPT Multilayer Plastic Syringe

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical

  • Comparison between glass and plastic syringe
  • Benefits of plastic syringe
  • Latest extractables study with 6 solvents representing typical biologics
  • Latest stability study with typical biologics
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    14:40

    Afternoon Tea Sponsored by ZEON

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    15:10

    Panel Discussion: The future of PFS injection devices from cross-industry expertise perspectives

  • What trends do we see coming?
  • What challenges will those trends bring?
  • Post-approval changes for combination products
  • Human Factor considerations
  • Manufacturing updates
  • Regulatory considerations
  • David Post, Director Science and Technology, AbbVie

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

    Paul Upham, Senior Principal, Genentech

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

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

    Ron Forster, Executive Director, Device & Final Drug Product Technologies, Amgen

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    15:50

    Tips, tricks and common sense for a successful Human Factors Usability file

    Debbie McConnell, Human Factors Manager, Worrell

  • Review what considerations make a usability file successful with Regulatory Bodies
  • Discuss how to interpret the standards/guidance as regulation evolves
  • Explore the Human Factors process through a wide range of devices’ Usability Engineering files
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    16:30

    Regulator expectations, guidance and approaches to Human Factors Validation of Injector Systems

    Tina Rees, Associate Director-Human Factors, Ferring Pharmaceuticals

  • FDA's expectations for HF validation of injector systems
  • Human Factors guidance and examples of approaches that have been successful and unsuccessful
  • Common pitfalls of Human Factors validation in injector systems
  • validating biosimilars in injection platforms
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    17:10

    Chairman’s Closing Remarks and Close of Day Two


    Director or Marketing
    Terumo Medical Corporation
    Associate Director / Device Development Lead
    Shire
    Senior Manager, Product Management
    West Pharmaceutical Services, Inc.
    Lead Clinical Analyst
    Matchstick
    Executive Director, Head Drug Device Centre of Excellence
    Merck
    Director Science and Technology
    AbbVie
    Human Factors Manager
    Worrell
    Consultant - Technical Advisor on Human Factors, Retired Director of HF
    AbbVie
    Head of Business Development
    iO Lifesciences
    Senior Engineer
    Amgen
    Academic Partnerships and Business Development
    iO Lifesciences
    Sr Business Development Specialist
    ZEON
    Quality Portfolio Support and Innovation-Drug Delivery Systems and Medical Devices
    Pfizer
    Director, Packaging Design and Development
    Allergan
    Sr. Manager, Drug Delivery and Device Development
    MedImmune
    Senior Principal
    Genentech
    Executive Director, Device & Final Drug Product Technologies
    Amgen
    Director, Product Management
    West Pharmaceutical Services, Inc.
    Global Category Manager Parenteral
    Nemera
    Researcher
    Mitsubishi Gas Chemical
    Associate Director-Human Factors
    Ferring Pharmaceuticals
    Senior Associate Director, Manufacturing Operations
    Boehringer Ingelheim
    Engineer
    Amgen

    Sponsors and Exhibitors

    Supporters

    [Attendee list] - PFS West Coast 2018

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    [Programme] - Pre-Filled Syringes West Coast 2018

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    [Speaker Line-up] - PFS West Coast 2018

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    [Workshop A] - Programme

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    [Presentations] - PFS West Coast 2017 presentations

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    [Interview] - AbbVie

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    [Interview] - Terumo Corporation

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    [Interview] - Genentech

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    [Welcome Letter] - Co-Chairs of the PFS West Coast

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    [Infographics] - PFS Syringes West Coast

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    Sponsors and Exhibitors


    Almac Group

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

    Almac is an established contract development and manufacturing organization that provides an extensive range of integrated services to the pharmaceutical and biotech sectors globally. From our Audubon, PA facilities, Almac provides innovative commercial packaging solutions built upon quality & flexibility to support all your packing needs, from niche/orphan drug launches to high volume products. Our specialized packaging solutions for all biopharmaceutical dosage forms (vials, ampoules, pre-filled syringes, auto-injector pens) includes:
    • - Pack design and prototype generation
    • - Labeling, assembly and secondary packaging
    • - Complex kit assembly
    • - Temperature sensitive storage
    • - Serialization
    Our wide range of services and flexibility to handle projects of any size, makes us your preferred US packaging partner.


    CSS (Connecticut Spring & Stamping)

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

    CSS (Connecticut Spring & Stamping) is a customer-focused advanced manufacturing company. 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, sensors and wearables. CSS facilities are ISO 13485 certified. Leading OEMs and CMOs partner with CSS for design assistance and consistent volume production.


    Harro Höfliger

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

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.



    iO life science

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

    iO life science is a full-service medical device development partner, trusted by established and start-up healthcare innovators. We exist to improve the lives of patients by transforming our clients’ technologies into unique and attractive products with user needs at the core. We accelerate compliance with our agile and ISO13485-approved QMS.


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    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, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    Owen Mumford

    Sponsors and Exhibitors
    http://www.ompharmaservices.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.


    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 2017 net sales of $1.6 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.


    Worrell

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

    Worrell is a multifaceted healthcare design and innovation firm with offices in London, Minneapolis and Shanghai. Worrell provides expertise in research and strategy, user experience and industrial design, human factors engineering and prototyping. Working on the front lines with patients and healthcare professionals, Worrell uncovers unmet needs to bring new drug delivery, medical device, and digital health solutions to the market.


    Zebrasci

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

    ZebraSci is an independent, third party laboratory and a trusted partner for pharma and med device. Our cross-functional team is geared to deliver informed & integrated solutions for your device and packaging development projects. Operating through two dedicated Centers of Excellence (CoE), with over 20,000 ft2 of laboratory and manufacturing space between our East Coast & West Coast Facilities, we offer solutions throughout your entire product life-cycle, ensuring that your product is launched on time and on budget.


    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.

    Media Partners


    Colorado Bioscience

    Supporters
    http://www.cobioscience.com/

    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.


    Pharma Marketing News

    Supporters
    http://www.news.pharma-mkting.com/

    Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Pharmavision

    Supporters
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    ONdrugDelivery Magazine

    Supporters
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    Pharma Journalist

    Supporters
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    MedTube

    Supporters
    https://medtube.net/



    GBI

    Supporters
    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    SciDoc Publishers

    Supporters
    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    American Laboratory

    Supporters
    http://www.americanlaboratory.com

    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    SelectScience

    Supporters
    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.

    Crowne Plaza San Diego - Mission Valley

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    Crowne Plaza San Diego - Mission Valley

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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, SAE Media 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@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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