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Pre Filled Syringes East Coast
April 11 - April 12, 2018
Pre Filled Syringes East Coast

SAE Media Group's 5th Annual Pre-Filled Syringes East Coast 2018 Conference and Exhibition is just few days away

This event will give a unique insight in the areas of regulation, manufacturing, emerging trends and innovative solutions to the challenges facing the prefilled industry, helping attendees to secure global success for their devices.

This year’s agenda features:

  • Guidance on the regulations for device development
  • Human Factors considerations and end-user feedback
  • Highlight common pitfalls of good manufacturing practice and seek to solve these
  • Address the emerging challenges that biologic drugs present to pre-filled syringes
  • Showcase hot topics of combination products, including wearable devices, auto-injectors and patient-centric design
  • Interactive panel discussions led by industry experts

    Visit Download Centre to get programme, list of speakers, list of attendees and other exclusive content.

FEATURED SPEAKERS

Justin Lacombe

Justin Lacombe

Senior Manager Process Development, Teva Pharmaceuticals USA
Justin Wright

Justin Wright

Global Head of Innovation, Novartis
Kashappa-Goud Desai

Kashappa-Goud Desai

Associate Fellow, GSK
Michael Song

Michael Song

Sr. Manager, Drug Delivery and Device Development, MedImmune Inc
Molly Story

Molly Story

Head, Global Usability Engineering and Risk Management, Sanofi

Adrien Tisserand

Global Category Manager, Nemera
Adrien Tisserand

Adrien Tisserand is Global Category Manager – Parenteral of Nemera, a world leader in design and manufacturing of drug delivery device. As Global category manager, he is responsible of Client Intellectual Property projects and Nemera standard technology offering. Prior joining Nemera in 2013, Mr Tisserand worked for Janssen in Strategic marketing in United Kingdom.

Amit Khanolkar

Director, New Product Development Quality Engineering, Janssen
Amit Khanolkar

Amit Khanolkar has been with Janssen, Pharmaceutical Companies of Johnson & Johnson since 2014 in the Combination Product Center of Excellence. In his current role, Amit is involved in providing leadership and oversight for New Product Development of Janssen Combination Product pipeline.Amit has a background in Medical Device and Combination Product development, with 12 years in R&D in the Medical Device and 4 years in Quality Engineering in the Pharma sector of Johnson & Johnson; where he held successive roles of increasing responsibilities in development as well as commercialization of numerous medical devices and combination products. Amit has actively collaborated across operating companies/sectors of Johnson & Johnson and provided strategic leadership in evaluating product and technology concepts in drug device combinations and convergent technologies.
Prior to Johnson & Johnson, Amit worked in materials and process development of high performance polymer materials for the pharmaceutical/medical device and semiconductor applications.
Amit holds a Master of Science degree in Polymer Engineering from the University of Akron and an MBA from University of Florida. He is a certified Design Excellence Black Belt, Process Excellence Green Belt and also has a certification in Statistical Engineering.
 

Annie Diorio-Blum

Principal Industrial Designer, Battelle
Annie Diorio-Blum

Chris Franzese

Lead Clinical Analyst, Matchstick
Chris Franzese

Chris Franzese is a Lead Clinical Analyst 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 relevant to client projects. An experienced clinical trial researcher, Mr 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 and is pursuing a concurrent PharmD and MHS in Health Informatics from Fairleigh Dickinson University.

Eric Caro

Key Account Manager, Schreiner Medipharm
Eric Caro

Henri Akouka

Associate Director of Device Development, Teva Pharmaceuticals USA
Henri Akouka

Henri Akouka received a B.S. in Mechanical Engineering from Norwich University. In 2007, Henri joined MicroDose Therapeutx and developed an advanced embodiment of their Piezo-electronic Transducer based Dry Powder Inhaler technology through Phase 2 clinical trials and DFx activities. After the purchase by Teva, Henri continues leading device development, adding injectable biologics, DHF remediation, and Cybersecurity to his responsibilities, overseeing multiple development projects for the development of Phase 1 and Phase 2 clinical supplies for inhalation and injectables drug-device combinations and advising integrated drug-device development teams.

Janice Adkins

Associate Director, Regional Marketing Manager, BD Medical - Pharmaceutical Systems
Janice Adkins

Joke Maes

Product Manager, Terumo Pharmaceutical Solutions
Joke Maes

Joke Maes is a Product Manager at Terumo Pharmaceutical Solutions, a global company offering a wide range of innovative products related to drug delivery devices. She oversees the needle and infusion portfolio for bi-packing opportunities. Joke began her career in the pharmaceutical industry at Bayer Pharmaceuticals Belgium. She gradually evolved into roles of increasing responsibilities leading up to one of her more recent roles as Project Manager in Global Strategic Marketing in Hematology at Bayer Pharmaceuticals. Prior to joining Terumo, she was Product Manager for the hematology portfolio of Shire Belgium/Luxemburg.

Juha Mattila

Senior Product Manager, STERIS FINN-AQUA
Juha Mattila

Juha Mattila is Senior Product Manager for STERIS Finn-Aqua Sterilization systems. He has Bachelor’s degree in HVAC & process engineering and Master’s degree in Business Informatics, both from Helsinki Metropolia University of Applied Sciences. He joined STERIS in 2000 and has 18 years of experience with pharmaceutical and research process equipment and applications, including several years in R&D for STERIS FINN-AQUA products and systems. He has worked with several clients in the designs and installations in Europe, North America and Asia, an active conference presenter, and contributes as author/co-author for articles in professional journals. Juha is a member of ISPE Nordic Board of Directors, PDA, and Finnish Biosafety Network.

Justin Lacombe

Senior Manager Process Development, Teva Pharmaceuticals USA
Justin Lacombe

Justin Lacombe received a B.S. in Chemical Engineering from Virginia Tech and did his Ph.D. thesis research in fluid mechanics at Rutgers with post-doctoral projects with Sepracor and Albemarle. At Catalent, Justin worked on metered dose inhaler development programs, including pre-formulation and physico-chemical characterization. In 2011, Justin joined MicroDose Therapeutx and created a differentiated role in process development. After the purchase by Teva, Justin continues leading process development, adding device manufacturing to his responsibilities, overseeing multiple manufacturing projects for the production of Phase 1 and Phase 2 clinical supplies for inhalation drug-device combinations and advising integrated drug-device development teams.

Justin Wright

Global Head of Innovation, Novartis
Justin Wright

Having joined Eli Lilly in June 2015, Justin currently serves as Vice President, Drug Delivery Innovation at
Lilly’s Cambridge Innovation Center. In his current role, he is tasked to identify and develop distinct and
novel strategies and product systems for Lilly’s pipeline which cuts across diabetes, oncology, pain,
autoimmune, and Alzheimer’s disease. He is also leading efforts to establish a maker culture within Lilly
and developing new innovation and external partnership models in order to accelerate drug delivery
innovation.
Prior to joining Lilly, Justin spent 8 years at Becton Dickinson (BD) where he served in various roles
focused on identifying, developing, and commercializing drug delivery systems for the biotech, vaccine,
and pharmaceutical industries. During his time at BD he helped commercialize and launch more than 10
drug delivery systems and led efforts in defining the innovation agenda for BD’s $1bn drug delivery
portfolio.
Justin began his career Merck & Company where he spent seven years in roles of increasing
responsibility across new product development, product commercialization, and franchise management.
During his time at Merck he helped launch and commercialize 4 new drug products.
Justin holds a PhD in Bio-Organic chemistry from Clemson University and completed a research
fellowship at Harvard Medical School. He is the author of more than 35 patents and publications.

Kashappa-Goud Desai

Associate Fellow, GSK
Kashappa-Goud Desai

Dr. Kashappa Goud Desai is working in the Department of Biopharmaceutical Product Sciences, GlaxoSmithKline, King of Prussia. He has over 10 years of industrial and post-doctoral R&D experience. He earned his BS and MS degrees in Pharmacy, respectively, from Karnatak University and Rajiv Gandhi University of Health Sciences, India. Dr. Desai earned his PhD degree in Biotechnology from Korea University, Republic of Korea.

Dr. Desai is a recipient of several internationally acclaimed awards for his original research contributions. He has published 50 articles in peer-reviewed international journals, authored one book and book chapter, and presented extensively at numerous conferences. He is serving as a reviewer for several international journals in the field of Pharmaceutical Sciences.
 

Maria Linzmayer

Associate Director, Drug Delivery Devices, Merck
Maria Linzmayer

Technical lead supporting External Manufacturing, combination products and drug delivery devices (pre-filled syringes, pen injectors, dosing tubes). Extensive knowledge of drug delivery devices, their functionality, failure modes, compliance requirements, and use across a large, complex product portfolio of sterile products. Advanced end-to-end knowledge of sterile product and vaccine manufacturing including aseptic manufacturing processes, sterilization, packaging and distribution. In depth understanding of regulatory expectations, cGMP, validation, combination product, documentation, and change control requirements. Project Management for the development of alternative combination product images and product transfers. Education: Stevens Institute of Technology, Master of Engineering in Pharmaceutical Manufacturing, Bachelor in Materials Science.

Michael Doyle

Director, Medical Device Regulatory, CMC, Pfizer
Michael Doyle

Michael joined Pfizer Inc. in 2016 providing regulatory guidance to device and combination product development. Prior to joining Pfizer Inc. he was Global Director Regulatory Affairs at Analogic Corporation and earlier worked at Insulet Corporation, NxStage Medical Inc., Philips Medical Systems, and Boston Scientific. He has over 20 years of experience in global regulatory affairs in support of device and combination product worldwide approvals, including; auto-injectors, on-body injectors, insulin pumps, ultrasound systems, home-dialysis equipment, defibrillators, and patient monitors. Additionally, Michael is involved with AdvaMed Working Groups for Combination Products and Human Factors.

Michael Song

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

Michael Song is Sr. Manager leading Device Functionality, Safety and Digital Connectivity at MedImmune, a Member of the AstraZeneca Group. In his role he oversees device functionality test method development and testing; primary container science and technology; biocompatibility; and digital connectivity for biologic products. Prior to his current role, Michael led the Device and Package Engineering team at Adello Biologics. He also have 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 Story

Head, Global Usability Engineering and Risk Management, Sanofi
Molly Story

MOLLY FOLLETTE STORY, PhD is Head, Global Usability Engineering and Risk Management in Sanofi’s Medical Device Development Unit. She was formerly Human Factors and Accessible Medical Technology Specialist at FDA/CDRH/ODE, where she had an appointment to the Senior Biomedical Research Service. While at FDA, she authored, with Ron Kaye, the CDRH draft (2011) and final (2016) human factors guidance documents. Dr. Story has particular expertise in universal design of products and the accessibility and usability of medical devices. Dr. Story is Co-chair of AAMI’s Human Factors Engineering Committee.

Nathan Heacock

Associate Scientist, GSK
Nathan Heacock

Nathan earned his BS in Chemistry and Biochemistry from West Chester University in 2015. He started at GlaxoSmithKline as a contract worker with PPD in 2015. After significant contributions to the Syringe Second source stability study he was hired full time as an Associate Scientist in the BioPharm Product Science department of GSK in 2016.

Serge Dubeau

Vice President of Design and Human Factors , Worrell
Serge Dubeau

In his nearly 20 years of experience, Serge has lead design and engineering teams in a variety of projects for both Fortune 100 and start up companies, resulting in various design awards and more than a dozen patents. He currently leads the design and human factors engineering teams at Worrell, focusing on user and patient safety. He holds a degree in Industrial Design from the University of Montreal, and is multi-lingual, having lived and worked in Spain, Canada and the United States.

Shota Arakawa

Researcher , Mitsubishi Gas Chemical America Inc
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.
 

Steve Bowman

Device Program Lead, Shire US Inc
Steve Bowman

Dr. Steve Bowman joined Shire in 2015 as the Leader of the newly-formed Device Center of Excellence, in recognition of the increasing importance of devices and combination products to Shire’s continued growth. He’s now the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities. Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair. He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management. Steve earned a BS in Mechanical Engineering from Columbia University, and a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Tieming Ruan

Associate Director of Device Development, Takeda
Tieming Ruan

Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Associate Director of Device Development and leading the combination devices development at Takeda. He has been working for various biotech and medical device companies in the past fifteen years and hold 10+ patents of drug delivery devices.

Toshiro Katayama

Product Manager, Zeon Specialty Materials Inc
Toshiro Katayama

Toshiro Katayama is the product manager, at Zeon Specialty Materials Inc and responsible in development of Cyclic Olefin Polymer business in the USA. He has over 35 years of various commercial experience, general management, sales and market management, strategic planning, merger and acquisition and purchasing at Gets Bros. & Co Inc (Marmon Group), Union Carbide Corp and Itoh-Chu. He holds Bachelor of Science degree in Mechanical Engineering and Master of Science degree in Structural Engineering from Polytechnic Institute of Brooklyn.

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Workshop Leaders' Opening Remarks and Introduction

Annie Diorio-Blum

Annie Diorio-Blum, Principal Industrial Designer, Battelle

Scott Ulrich

Scott Ulrich, Senior Industrial Design Leader, Battelle

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9:10

Exploring diverse users and use environments

  • Breakout Groups
  • How to draft profiles for users and environments with design inputs in mind
  • Annie Diorio-Blum

    Annie Diorio-Blum, Principal Industrial Designer, Battelle

    Scott Ulrich

    Scott Ulrich, Senior Industrial Design Leader, Battelle

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    10:10

    Getting the most out of early user research

  • Case Studies
  • How user environment profiles inform plans for early user research
  • Annie Diorio-Blum

    Annie Diorio-Blum, Principal Industrial Designer, Battelle

    Scott Ulrich

    Scott Ulrich, Senior Industrial Design Leader, Battelle

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    10:30

    Morning Coffee

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    11:00

    Mapping user needs to user interface requirements

  • Case Studies
  • How to trace user research findings to user needs and user interface requirements
  • Annie Diorio-Blum

    Annie Diorio-Blum, Principal Industrial Designer, Battelle

    Scott Ulrich

    Scott Ulrich, Senior Industrial Design Leader, Battelle

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    11:30

    Providing a complete support system

  • Discussion
  • Use outside the clinic requires multiple forms of support
  • Discussion
  • Instructions for Us are part of the user interface and should be created using a Human Centric Design approach
  • Annie Diorio-Blum

    Annie Diorio-Blum, Principal Industrial Designer, Battelle

    Scott Ulrich

    Scott Ulrich, Senior Industrial Design Leader, Battelle

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    12:30

    Closing Remarks from Workshop Leaders' and End of Morning Workshop

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    13:30

    Workshop Registration and Welcome Coffee

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    14:00

    Workshop Leader Introduction

    Maureen Halligan

    Maureen Halligan, Principal Human Factors Engineer, Cambridge Consultants

    Adrienne Erdman

    Adrienne Erdman, Senior Human Factors Engineer, Cambridge Consultants

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    14:15

    Overview of Human Factors for medical development

  • Human Factors Engineering process
  • Regulatory requirements
  • Commercial goals
  • Human Factors Engineering process
  • Regulatory requirements
  • Commercial goals
  • Adrienne Erdman

    Adrienne Erdman, Senior Human Factors Engineer, Cambridge Consultants

    Maureen Halligan

    Maureen Halligan, Principal Human Factors Engineer, Cambridge Consultants

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    14:45

    Overview off the regulatory landscape for digital health

  • Is it a medical system or not?
  • Consumer digital systems
  • Medical digital systems
  • Is it a medical system or not?
  • Consumer digital systems
  • Medical digital systems
  • Maureen Halligan

    Maureen Halligan, Principal Human Factors Engineer, Cambridge Consultants

    Adrienne Erdman

    Adrienne Erdman, Senior Human Factors Engineer, Cambridge Consultants

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    15:10

    Afternoon Tea and Networking Break

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    16:00

    Bringing digital into the HF process

  • How does it impact the process?
  • What is the UX and how is it interpreted for hybrid systems?
  • Tools, methodologies and best practices
  • How does it impact the process?
  • What is the UX and how is it interpreted for hybrid systems?
  • Tools, methodologies and best practices
  • Adrienne Erdman

    Adrienne Erdman, Senior Human Factors Engineer, Cambridge Consultants

    Maureen Halligan

    Maureen Halligan, Principal Human Factors Engineer, Cambridge Consultants

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    16:30

    Validation of the digital health

    Maureen Halligan

    Maureen Halligan, Principal Human Factors Engineer, Cambridge Consultants

    Adrienne Erdman

    Adrienne Erdman, Senior Human Factors Engineer, Cambridge Consultants

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    17:00

    Closing Remarks from Workshop Leader and End of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Steve Bowman, Device Program Lead, Shire US Inc

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    9:10

    Syringe filling of high-concentration monocolonal antibody formulation: Challenges and solutions

    Kashappa-Goud Desai, Associate Fellow, GSK

  • There has been a steady increase in the number of high-concentration mAb formulations in ready-to-use pre-filled syringes for subcutaneous administration
  • Challenges of successful syringe filling of high-concentration mAb formulations by an automated filling machine
  • Outlining challenges associated with syringe filling of high-concentration formulations
  • This presentation summarizes the key challenges and mitigation strategies
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    9:50

    Silicone related concerns associated with prefilled devices and innovative strategies of risk mitigation

    Janice Adkins

    Janice Adkins, Associate Director, Regional Marketing Manager, BD Medical - Pharmaceutical Systems

  • Silicone as the gold standard lubricant for prefilled syringes
  • Outlining concerns that silicone may contribute to elevated particle levels, potential drug/silicone interactions or incomplete drug delivery due to stalling auto-injectors
  • The innovative XSi™ coating
  • Addressing silicone related concerns
  • XSi™ leveraging the vast body of evidence on glass syringes and compatibility with existing fill/finish infrastructure
     
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    10:30

    Morning Coffee Sponsored by Zeon

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    11:00

    COP - Technical data update

    Toshiro Katayama, Product Manager, Zeon Specialty Materials Inc

  • Key properties of COP - update
  • Case Study: Study on Protein adsorption/aggregation with actual protein drug - COP vs. glass
  • Case Study: Study on delamination with glass syringe vs. COP syringe
  • Leachable data on COP syringe with various chemicals
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    11:40

    Drug-device combination product development challenges

    Amit Khanolkar, Director, New Product Development Quality Engineering, Janssen

  • Combination products: Application of drugs with medical devices minimizes adverse events, while maximizing treatment response and positive user experiences
  • Compare and contrast the drug and device development processes and integration of the two
  • Combination products risk management
  • Dynamic combination products regulatory environment
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    12:20

    EU Medical Device Regulation (MDR) Implications

    Michael Doyle, Director, Medical Device Regulatory, CMC, Pfizer

  • Overview
  • Timeline/Enforcement
  • Medicinal Products
  • General safety & performance requirements / Common specifications
  • Technical documentation
  • Obligations
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    13:00

    Networking Lunch Sponsored by Terumo

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    14:00

    Injection device – Investigation of pain perception influencing factors

    Adrien Tisserand, Global Category Manager, Nemera

  • Parenteral parameter mapping
  • Device impacts
  • Drug impacts
  • User impacts
  • Technical proposal
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    14:40

    Pre-filled syringe second source initiative: A dual source identification to reduce supply using Quality-by-Design (QbD) principles

  • Understanding Quality by Design (QbD)
  • A global regulatory initiative with the goal of enhancing the quality of combination products
  • Summary of the application of QbD principles for combination product development
  • Evaluation of syringe second source by applying QbD principles
  • Kashappa-Goud Desai, Associate Fellow, GSK

    Nathan Heacock, Associate Scientist, GSK

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    15:20

    The best plastic syringe for biologics

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical America Inc

  • OXYCAPT Multilayer Plastic Syringe having Glass-like Oxygen Barrier
  • Excellent Oxygen Barrier contributes to Stability of Biologics
  • Very Low Extractables contribute to Stability of Biologics
  • Good UV Barrier contributes to Stability of Biologics
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    16:00

    Afternoon Tea Sponsored by Zeon

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    16:30

    Case Studies: Uncover user needs that can translate into design inputs

    Serge Dubeau, Vice President of Design and Human Factors , Worrell

  • Explore case studies using techniques and technologies to uncover essential user insights earlier
  • Discuss how to customize and scale your research appropriately
  • Review user needs that change design inputs
  • Describe how human factors and usability evaluations can be leveraged to fuel your design process as well as meet regulatory requirements
     
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    17:10

    Integrating drug-device combination product development

  • Integrating the design process with methodical pharmaceutical development
  • QbD and design controls as a paradigm for aligning combination development
  • Comparison with regulatory guidance on Combination Products and the current state of development of drug device development
  • Justin Lacombe, Senior Manager Process Development, Teva Pharmaceuticals USA

    Henri Akouka, Associate Director of Device Development, Teva Pharmaceuticals USA

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    17:50

    Chairman’s Closing Remarks

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Michael Doyle, Director, Medical Device Regulatory, CMC, Pfizer

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    9:10

    Keynote Address: The critical importance of recognizing the considerations, decisions and trade-offs inherent in all combination product development

    Steve Bowman, Device Program Lead, Shire US Inc

  • Your product has multiple customers beyond patients - do you know all of them? How well? Are you sure? Prove it!
  • The saying "a chain is a s strong as its weakest link" applies to combination product development too. What's yours (likely there are many)? What are you doing to address them?
  • The future of combination products is bright - but are we confident we know what it will look like?
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    9:50

    The Challenges of Platformization

    Molly Story, Head, Global Usability Engineering and Risk Management, Sanofi

  • From a human factors perspective, what would it take to create a device that is a true platform which can be utilized for multiple molecules and a variety of user groups?
  • What effects might the choice of molecule have on design of the device?
  • What effects might the choice of molecule have on the user's interactions with the device?
  • For which users should the device be designed?
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    10:30

    Morning Coffee Sponsored by Zeon

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    11:00

    Pediatric Hemophilia: Developing Pre-Formative Insights to Guide Innovation

  • 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
  • Joke Maes, Product Manager, Terumo Pharmaceutical Solutions

    Chris Franzese, Lead Clinical Analyst, Matchstick

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    11:40

    Future of digitally connected device and changing paradigm in disease management

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

  • Digitalization: Benefits of electronic-enabled drug delivery devices in patient disease management beyond adherence
  • Tackling hurdles of connectivity for combination products: cost, technology, regulatory and time-to-market considerations
  • Evaluating add-on platforms as a step towards integrated device ecosystem
  • Exploring opportunities for pharma, patient and HCP engagement through connected drug delivery devices
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    12:20

    Networking Lunch Sponsored by Terumo

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    13:20

    Smart Labeling Solutions for Pre-filled Syringes: Patient Centricity Enhanced

    Eric Caro

    Eric Caro, Key Account Manager, Schreiner Medipharm

  • Innovative RFID/NFC solutions to improve user experience and patient safety through connectivity
  • Customizing injection devices with multi-functional labels
  • User-friendly, label-integrated needlestick prevention
  • Low migration labels and challenges of COC/COP materials
  • Ensuring container integrity through novel technologies
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    14:00

    Lessons learned from Human Factor studies of pre-filled syringes

    Tieming Ruan, Associate Director of Device Development, Takeda

  • Formative study versus Summative study: Are both formative and summative studies required if an off-shelf product is used with certain modification?
  • Number of arms: How many arms need to be included in the human factor studies? IFU only, IFU + QRG or QRG only
  • Use Errors: How to deal with Use Errors found from Human Factor studies and what if these Use Errors can't be mitigated?
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    14:40

    New developments in low temperature VHP terminal surface sterilization and PFS material compatibility

    Juha Mattila, Senior Product Manager, STERIS FINN-AQUA

  • New developments in VHP (Vaporized Hydrogen Peroxide) surface sterilization technology
  • VHP Low temperature terminal surface sterilization process principle
  • Testing results: Filled COP plastic container exposure to low temperature VHP deep vacuum surface sterilization
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    15:20

    Afternoon Tea Sponsored by Zeon

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    15:50

    PFS tech transfer of in-line products not originally developed as combination products

    Maria Linzmayer, Associate Director, Drug Delivery Devices, Merck

  • Defining Design User Requirements
  • Dealing with suppliers providing device constituent components
  • Systems engineering needs
  • Retrospective design documentation
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    16:30

    Chairman’s Closing Remarks and Close of Day Two


    Global Category Manager
    Nemera
    Director, New Product Development Quality Engineering
    Janssen
    Principal Industrial Designer
    Battelle
    Lead Clinical Analyst
    Matchstick
    Key Account Manager
    Schreiner Medipharm
    Associate Director of Device Development
    Teva Pharmaceuticals USA
    Associate Director, Regional Marketing Manager
    BD Medical - Pharmaceutical Systems
    Product Manager
    Terumo Pharmaceutical Solutions
    Senior Product Manager
    STERIS FINN-AQUA
    Senior Manager Process Development
    Teva Pharmaceuticals USA
    Global Head of Innovation
    Novartis
    Associate Fellow
    GSK
    Associate Director, Drug Delivery Devices
    Merck
    Director, Medical Device Regulatory, CMC
    Pfizer
    Sr. Manager, Drug Delivery and Device Development
    MedImmune Inc
    Head, Global Usability Engineering and Risk Management
    Sanofi
    Associate Scientist
    GSK
    Vice President of Design and Human Factors
    Worrell
    Researcher
    Mitsubishi Gas Chemical America Inc
    Device Program Lead
    Shire US Inc
    Associate Director of Device Development
    Takeda
    Product Manager
    Zeon Specialty Materials Inc

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    [Attendee list] - PFS East Coast 2018

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    [Press-release]

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    [Timed Programme] - PFS East Coast 2018

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    [List of speakers] - PFS East Coast 2018

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    [Workshop B] - Programme

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    [Workshop A] - Programme

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    [Infographics] - PFS East Coast

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    [Programme] - Pre-Filled Syringes Europe 2018

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    [Partner Press-Release] - Nemera

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    [Presentations] - snippets of PFS East Coast 2017 presentations

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    [Plan your visit]

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    [Interview] - Battelle

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    [Shire, Scynexis] - Letter from the chairs

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    [Interview] - Terumo Corporation

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    Sponsors and Exhibitors


    Aptar Pharma

    Sponsors and Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    BD

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

    BD is a medical technology company that serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD designs, manufactures and sells a broad range of medical supplies, devices, laboratory equipment and diagnostic products. BD Medical - Pharmaceutical Systems is the partner of choice for the pharmaceutical industry. With innovative prefillable syringes, self-injection systems, safety systems and needle technologies, we offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Our products reflect more than a century of experience and market knowledge, and our experts provide comprehensive system-based service and full product solutions.


    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.


    NN Precision Engineered Products

    Sponsors and Exhibitors
    http://www.pep-corp.com

    NN, Inc Precision Engineered Products Group is an engineered solutions company, focusing on medical and drug delivery devices. We provide components, complex assemblies and clean room packaging, specializing in metal stamping, injection molding and ISO Class VIII clean room assembly. Learn more at www.pep-corp.com.


    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.


    Plastic Ingenuity

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

    Plastic Ingenuity is a custom thermoformer that provides packaging for the drug delivery and pharmaceutical markets. We specialize in creating secondary packaging for pharmaceutical combination products and automation trays that integrate into high volume assembly equipment for our drug delivery partners. These parts run flawlessly on highly complex automated equipment.


    SCHOTT North America, Inc. – Pharmaceutical Packaging

    Sponsors and Exhibitors
    http://www.us.schott.com/pharma

    SCHOTT is a world leading supplier of parenteral packaging servicing the pharmaceutical, biotech, biopharmaceutical, diagnostic, analytical, dental & ophthalmic markets. Products include glass and polymer prefillable syringes (bulk and sterile), cartridges, ampoules, vials, and innovative coated containers. Ready-to-use solutions are available to meet existing and new fill & finish equipment.


    Schreiner MediPharm

    Sponsors and Exhibitors
    http://www.schreiner-medipharm.com

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.


    STERIS

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

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.



    Suttons Creek

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

    Suttons Creek is your device team. Instantly leverage our experience on over 40 drug delivery systems, including pre-filled syringes (PFSs), lyophilized reconstitution kits (Lyo-kits), autoinjectors (AIs), inhalers, and on-body devices. Drastically reduce your development time and your regulatory, quality, development, and business risk by leveraging our Forge Development Process. Ask how we can support your device program or add to the capability of your organization.


    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.


    TOPAS Advanced Polymers

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

    TOPAS Advanced Polymers is a leading maker of COC (cyclic olefin copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes and vials. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission.


    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


    ONdrugDelivery Magazine

    Official Media Partner
    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.


    American Pharmaceutical Review

    Official Media Partner
    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


    Drug Delivery Business News

    Official Media Partner
    https://www.drugdeliverybusiness.com/

    Drug Delivery Business News provides day-to-day news and information on the cutting-edge field of drug delivery and the companies that drive it. From clinical development to regulatory approvals to commercial milestones, we track the latest in drug delivery research and trends. Drug Delivery Business News brings you originally-reported, quality news coverage of the rapidly developing drug delivery market, reaching an audience of more than 15,000 each month


    Colorado Bioscience

    Official Media Partner
    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.

    Media Partners


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    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.


    MedTube

    Supporters
    https://medtube.net/



    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.


    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.


    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.


    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.


    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/


    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.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    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!


    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.


    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.


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.


    International Pharmaceutical Industry

    Supporters
    http://www.ipimediaworld.com

    IPI gives you an insight into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. IPI provides a proven supportive means of communication to the Pharmaceutical, Bio Pharmaceutical, Nutraceutical and Medical Devices industry, incorporating the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies.


    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.


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Medical Device Network

    Supporters
    http://www.medicaldevice-network.com/

    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.


    Manufacturing Chemist

    Supporters
    http://www.manufacturingchemist.com

    Manufacturing Chemist is among the longest established and most respected information sources in the global pharmaceutical manufacturing industry. Manufacturing Chemist reports on current and future trends in the global marketplace, including the latest developments in drug discovery, biotechnology, drug delivery, ingredients, processing technologies and equipment, packaging, business strategies and regulatory updates.


    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.


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    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.


    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


    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.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    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.


    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.


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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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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    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
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