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3rd Annual Pre-Filled Syringes East Coast
April 25 - April 26, 2016
3rd Annual Pre-Filled Syringes East Coast

SAE Media Group’s 3rd annual Pre-Filled Syringes East Coast conference returns to the New Jersey in April 2016.

With exponential growth of biologics and protein-based products, demand for pre-filled syringes (PFS) is growing on an exponential scale. As such, the global pre-filled syringes (PFS) market is presenting lucrative opportunities for both pharma and device companies- the investment forecast expects to exceed $6.6.bn by 2020. According to a recent study led by Brigham and Women's Hospital (BWH) in Boston*, switching to PFS can also cut related costs by almost 50%, equivalent to $162,000 in savings! 

While we have witnessed booming investments in PFS, pharma and device manufacturers still need to overcome a number of challenges to commercialize PFS. It also faces fierce competition with innovative drug delivery platforms. Hence, developing a drug-compatible and patient-centric PFS remain top priority amongst market participant.

Emulating on previous success, the 3rd Annual Pre-Filled Syringes East Coast will delve further into the core issues of PFS including

  • human factor engineering
  • PFS material selection and GMP compliance
  • compatibility and injectability considerations for complex biologics and combination product

and many more!

Join us today and don't miss out on this must-attend event!

*Source: http://bit.ly/1UmygT3

Conference LEADER

keynote-img

Ravi S. Harapanhalli

Principal, FDAPharma Consulting LLC

Ravi S. Harapanhalli, Ph.D., Principal at FDAPharma Consulting, advises bio/pharmaceutical/device companies on regulatory strategies and Quality-by-Design approaches to medicinal product development and flexible regulatory approaches for drugs, biologics, and drug-device combination products. He also helps companies devise appropriate clinical and regulatory strategies such as 505(b)(2) versus 505(j), biosimilars, and biologics.

Until September of 2015, he was Vice President at PAREXEL International, and served as a Branch Chief in the Office of New Drug Quality Assessment, US FDA. During his tenure of over 7 years at PAREXEL, he worked with numerous clients in developing and getting approvals for their products. He brings his extensive FDA regulatory experience of over 11 years in this consulting strategies. He has wide experience in the CMC/biopharmaceutics review and inspection of a broad range of dosage forms and drug products including radiopharmaceuticals, parenterals, injectable suspensions, solid oral dosage forms, inhalation products, transdermal and topical systems, gels, and combination products including iontophoretic patches, pre-filled syringes and autoinjectors. He has over 25 years of extensive experience in the pharma/biopharma/combination product areas spanning 12 years at US FDA, 8 years in consulting, 11 years in R&D and Biomedical Research and has published over 30 peer-reviewed publications and holds a patent in tumor treatment from Harvard Medical School. He actively presents at national and international meetings on various aspects of medicinal product development.


 

FEATURED SPEAKERS

Carsten Worsoe

Carsten Worsoe

Principal Scientist, CMC Analytical Support, Novo Nordisk
Isabelle Delcroix

Isabelle Delcroix

Business Development Director, Nemera
Jason Lipman

Jason Lipman

Associate Director, Regulatory Affairs, Medical Devices & Combination Products , Janssen R&D LLC
Mathias Romacker

Mathias Romacker

Drug Delivery Devices, Pfizer
Paolo Mangiagalli

Paolo Mangiagalli

Senior Director, Head PFS/ Primary Container Platform, Sanofi S A
Ravi S. Harapanhalli

Ravi S. Harapanhalli

Principal, FDAPharma Consulting
Stephen Barat

Stephen Barat

Executive Director, Non-Clinical & Translational Sciences, Allergan

Bobbijo Redler

Principal Scientist, MSD
Bobbijo Redler

Carsten Worsoe

Principal Scientist, CMC Analytical Support, Novo Nordisk
Carsten Worsoe

Evan Goulet

Director, Sterilization Operations, Noxilizer, Inc.
Evan Goulet

Isabelle Delcroix

Business Development Director, Nemera
Isabelle Delcroix

Jason Lipman

Associate Director, Regulatory Affairs, Medical Devices & Combination Products , Janssen R&D LLC
Jason Lipman

Ken Wong

Deputy Director, MTech/ Process Technology – Extractables & Leachables, Sanofi Pasteur
Ken Wong

Kenichiro Usuda

Researcher, Advanced Business Development Division, MITSUBISHI GAS CHEMICAL COMPANY, INC
Kenichiro Usuda

Mathias Romacker

Drug Delivery Devices, Pfizer
Mathias Romacker

Melanie Turieo

Director, Human Factors Engineering, Cambridge Consultants
Melanie Turieo

Melanie Turieo is an Associate Director in Cambridge Consultants’ Global MedTech division, and Group Leader for Human Factors Engineering & Industrial Design. Melanie has 20 years’ experience providing human factors expertise to the design and development of regulated and safety-critical items, including medical, military and consumer products. Her technical expertise has focused for the last 10 years on Human Factors Engineering in the design and development of medical products, and she has extensive experience designing and conducting user research for medical devices, especially drug delivery systems including injection and inhalation technology.
 

Mitsuru Takahashi

Technology Development Manager, Terumo Americas Holding, Inc
Mitsuru Takahashi

Padam Sharma

Injectables, Sterile Manufacturing & Dev. Global Pharmaceutical Technology, Allergan Inc
Padam Sharma

Paolo Mangiagalli

Senior Director, Head PFS/ Primary Container Platform, Sanofi S A
Paolo Mangiagalli

Ravi S. Harapanhalli

Principal, FDAPharma Consulting LLC
Ravi S. Harapanhalli

Ravi S. Harapanhalli, Ph.D., Principal at FDAPharma Consulting, advises bio/pharmaceutical/device companies on regulatory strategies and Quality-by-Design approaches to medicinal product development and flexible regulatory approaches for drugs, biologics, and drug-device combination products. He also helps companies devise appropriate clinical and regulatory strategies such as 505(b)(2) versus 505(j), biosimilars, and biologics.

Until September of 2015, he was Vice President at PAREXEL International, and served as a Branch Chief in the Office of New Drug Quality Assessment, US FDA. During his tenure of over 7 years at PAREXEL, he worked with numerous clients in developing and getting approvals for their products. He brings his extensive FDA regulatory experience of over 11 years in this consulting strategies. He has wide experience in the CMC/biopharmaceutics review and inspection of a broad range of dosage forms and drug products including radiopharmaceuticals, parenterals, injectable suspensions, solid oral dosage forms, inhalation products, transdermal and topical systems, gels, and combination products including iontophoretic patches, pre-filled syringes and autoinjectors. He has over 25 years of extensive experience in the pharma/biopharma/combination product areas spanning 12 years at US FDA, 8 years in consulting, 11 years in R&D and Biomedical Research and has published over 30 peer-reviewed publications and holds a patent in tumor treatment from Harvard Medical School. He actively presents at national and international meetings on various aspects of medicinal product development.


 

Roja Narwal

Scientist II, Formulation Sciences, MedImmune
Roja Narwal

Rowland Yovonie

Manager of Quality & Statistical Engineering, Genentech
Rowland Yovonie

Royce Brockett

Senior Product Manager, PFS Platform, West Pharmaceutical Services, Inc.
Royce Brockett

Shawn Davis

Principal Engineer, Device Strategy, Amgen
Shawn Davis

Stephen Barat

Executive Director, Non-Clinical & Translational Sciences, Allergan
Stephen Barat

Tiffany McIntire

Human Factors Engineer, Eli Lilly & Company
Tiffany McIntire

Tina Kiang

Deputy Director Science and Policy, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID), FDA
Tina Kiang

Toshiro Katayama

Product Manager, Zeon Chemicals L.P.
Toshiro Katayama

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Workshop Leader’s Opening and Introduction

Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants

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9:10

Overview of Human Factors Engineering (HFE) for PFS

  • How HF applies to PFS
  • What are the considerations and what are the regulators expecting?
  • Planning ahead for your supporting rationale - how to address HF validation results in context
  • Examples
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    10:30

    Morning Coffee & Networking Break

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    11:00

    Creating a Consistent User Experience

  • Marrying safety, usability and commercial success
  • User interface of the device - packaging, instructional materials, training and other 'peripherals'
  • Realizing efficiencies in the development process and accelerating validation readiness
  • Case study
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    12:00

    Q&A

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    12:30

    Closing Remarks from Workshop Leader and End of Workshop

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    13:30

    Registration & Coffee

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    14:00

    Workshop Leader's Opening Introduction

    Ravi S. Harapanhalli, Principal, FDAPharma Consulting LLC

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    14:10

    Future Applications for PFS and Autoinjectors in Personalized Medicines

  • Personalized medicine and development landscape for PFS/autoinjectors
  • Working of the Office of Combination Products
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    15:10

    Regulatory Considerations and Combination Rules

  • CMC considerations in the development of PFS/autoinjectors
  • Regulatory issues and risk assessment
  • Streamlining of 21CFR Part 4 for PFS/autoinjectors
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    16:00

    Afternoon Tea & Networking Break

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    16:30

    Incorporating Human Factors into PFS and Autoinjectors

  • Usability and human factor considerations
  • Case studies and discussion
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    17:30

    Workshop Leader’s Closing Remarks and Close of Workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Principal, FDAPharma Consulting

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    9:10

    Safety Assessment and Regulatory Updates on Pre-Filled Syringes and Combination Products

    Tina Kiang

    Tina Kiang, Deputy Director Science and Policy, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID), FDA

  • Updates on latest regulatory requirements and expectations from FDA
  • Taking consumers and patients into consideration - human factors
  • Demonstrating data and evidence early on for regulatory approval
  • Q&A
  • clock

    9:50

    The Top Priority for PFS – Addressing Regulatory Compliance and Clinical Needs

    Jason Lipman

    Jason Lipman, Associate Director, Regulatory Affairs, Medical Devices & Combination Products , Janssen R&D LLC

  • US-FDA specific requirements vs. critical issues for regulatory approval in the EU
  • What is required by the regulators for post-marketing
  • Concerns with combination products – challenges and solutions
  • clock

    10:30

    Extractables and Leachables (E&L): The Value of the Simulated Study as a Prediction Tool for Actual Leachables in PFS

    Carsten Worsoe

    Carsten Worsoe, Principal Scientist, CMC Analytical Support, Novo Nordisk

  • Relationship between extractables, simulated leachables and leachables
  • What is the optimal tool to predict leachables in a PFS?
  • How to perform a simulated study for a PFS
  • Case studies: Examples on simulated studies in PFS
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    11:10

    Morning Coffee & Networking Break

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    11:40

    PLAJEX™ Polymer-Based Pre-Filled Syringes (PFS) and its Value with a Novel Tapered Needle Design

    Mitsuru Takahashi

    Mitsuru Takahashi, Technology Development Manager, Terumo Americas Holding, Inc

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    12:20

    Critical Steps for PFS Integration – From Early Stage to a Functional Delivery System

    Paolo Mangiagalli

    Paolo Mangiagalli, Senior Director, Head PFS/ Primary Container Platform, Sanofi S A

  • Translating integrated system approach into component requirements
  • How to ensure effective PFS component control plans
  • Open issues for PFS system and opportunities for knowledge sharing
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    13:00

    Networking Lunch

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    14:00

    Key Properties of COP Update

    Toshiro Katayama

    Toshiro Katayama, Product Manager, Zeon Chemicals L.P.

  • Case study: Protein adsorption data – COP vs. glass
  • Case study: Study on delamination with glass syringe vs. COP syringe
  • Leachable data on COP syringe with various chemicals
  • clock

    14:40

    Challenges in Development of Primary Containers for Devices – Case Studies

    Roja Narwal

    Roja Narwal, Scientist II, Formulation Sciences, MedImmune

  • Development of platform syringe configurations suitable for sensitive biologics
  • How formulation development studies can enable successful device development
  • Challenges with development of primary containers for devices
  • clock

    15:20

    Syringes for the Sterile Field: Nitrogen Dioxide Sterilization as a Solution

    Evan Goulet

    Evan Goulet, Director, Sterilization Operations, Noxilizer, Inc.

  • The NO2 sterilization process is designed to minimize impact on temperature- and pressure-sensitive drugs and biologics
  • Discussing load configuration, biological indicator locations and process data
  • Container-closure system integrity demonstration via sterility and NO2 ingress testing
  • Single batch release process for clinical trials
  • clock

    16:00

    Afternoon Tea & Networking Break

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    16:30

    An E&L Qualification Case Study of New Label on Plastic PFS

    Ken Wong

    Ken Wong, Deputy Director, MTech/ Process Technology – Extractables & Leachables, Sanofi Pasteur

  • Extractable studies on ink, label and adhesive
  • Simulated in-use leachable study with labelled plastic PFS
  • Leachable migration study from label into the plastic syringe
  • clock

    17:10

    Achieving Patient-Centred Design through Human Factors

    Tiffany McIntire

    Tiffany McIntire, Human Factors Engineer, Eli Lilly & Company

  • Understanding the multifaceted field of human factors and the process
  • Why human factors evaluation methods are necessary to achieve optimized design
  • Using user needs to drive human factors process and demonstrate traceability from requirements to validation outputs
  • clock

    17:50

    Roundtable Discussion: The Future of Combination Product Review Process at FDA

  • The contributions of the Office of Combination Products to date
  • Review of a recent report by the Office of Planning at FDA entitled ‘Combination Product Review: Intercenter Consult Process Study, Oct 14, 2015’
  • What is expected of combination product review process in the future
  • Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Principal, FDAPharma Consulting

    Padam Sharma

    Padam Sharma, Injectables, Sterile Manufacturing & Dev. Global Pharmaceutical Technology, Allergan Inc

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    18:30

    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

    Stephen Barat

    Stephen Barat, Executive Director, Non-Clinical & Translational Sciences, Allergan

    clock

    9:10

    Current Market Developments and Global Market Trends for Advanced Injection Devices

    Mathias Romacker

    Mathias Romacker, Drug Delivery Devices, Pfizer

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    9:50

    Risk Based Statistical Sampling for Medical Device and Combination Products

    Rowland Yovonie

    Rowland Yovonie, Manager of Quality & Statistical Engineering, Genentech

  • How to apply statistical inputs for an informed decision – from product design to manufacturing
  • Improve product quality and escape regulatory risk
  • Technical challenges with more complexbiologics products
  • clock

    10:30

    Emerging Trends in Pre-Filled Delivery: Next Generation Component Innovations and Risk Mitigation Strategies

    Royce Brockett

    Royce Brockett, Senior Product Manager, PFS Platform, West Pharmaceutical Services, Inc.

  • Market trends in pre-filled delivery and self-injection
  • New approaches to development and risk mitigation for components
  • Next generation components; designed for enhanced quality and optimized performance to meet evolving prefilled delivery requirements
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    11:10

    Morning Coffee & Networking Break

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    11:40

    Challenges for PFS with More Complex Biologics Drugs

    Shawn Davis

    Shawn Davis, Principal Engineer, Device Strategy, Amgen

  • Escalating dosages (volume and viscosity considerations)
  • PFS vs. autoinjector
  • Viability and efficacy – can we reduce the dosage frequency effectively for patients’ use?
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    12:20

    How Parenteral Combination Products Can Improve Drug Delivery? Insights into Patients’ Intuitive Solutions, Design Risk Analysis and Robust Processes

    Isabelle Delcroix

    Isabelle Delcroix, Business Development Director, Nemera

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    13:00

    Networking Lunch

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    14:00

    OXY-CAPTTM Multilayer Plastic Pre-Filled Syringe with Glass-Like Gas Barrier

    Kenichiro Usuda

    Kenichiro Usuda, Researcher, Advanced Business Development Division, MITSUBISHI GAS CHEMICAL COMPANY, INC

  • Introducing ‘OXY-CAPTTM Multilayer Plastic Syringe’ made of glass-like gas barrier polymer and COP
  • Update on oxygen barrier study of OXY-CAPTTM syringe
  • Key benefits and features of OXY-CAPTTM syringe comparing to COP monolayer and glass syringe
  • clock

    14:40

    Thinking it From the Start – How to Compile a Strong E&L Case for the Regulatory Agency

    Bobbijo Redler

    Bobbijo Redler, Principal Scientist, MSD

     

  • Updates on E&L testing methods and how this will impact on your device design
  • Clarity is key – what do the regulatory agencies expect?
  • How to demonstrate evidence and incorporate this into your device development plan to ensure a smooth approval process?
  • clock

    15:20

    Afternoon Tea & Networking Break

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    15:50

    Safety Assessment of Leachables for the Development of Pre-Filled Syringe and Parenteral Drug Products

    Stephen Barat

    Stephen Barat, Executive Director, Non-Clinical & Translational Sciences, Allergan

  • An overview of leachables encountered in parenteral drug products – and need for safety assessment - will be presented
  • Approaches to adequate safety evaluation related to the development of a pre-filled syringe combination drug products will be provided, illustrated with tangible examples.
  • Final PQRI best practice recommendations for leachable safety assessment for parenteral drug products will be covered
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    16:30

    Panel Discussion: What Are the Latest Innovations in PFS?

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Principal, FDAPharma Consulting

  • How ergonometrics can help with a good design of PFS to increase value and compliance?
  • Who and how? Always put your patients at heart
  • The rise of e-apps and e-device for patient monitoring – how can this apply to PFS?
  • clock

    17:00

    Chairman’s Closing Remarks and Close of Day Two


    Principal Scientist
    MSD
    Principal Scientist, CMC Analytical Support
    Novo Nordisk
    Director, Sterilization Operations
    Noxilizer, Inc.
    Business Development Director
    Nemera
    Associate Director, Regulatory Affairs, Medical Devices & Combination Products
    Janssen R&D LLC
    Deputy Director, MTech/ Process Technology – Extractables & Leachables
    Sanofi Pasteur
    Researcher, Advanced Business Development Division
    MITSUBISHI GAS CHEMICAL COMPANY, INC
    Drug Delivery Devices
    Pfizer
    Director, Human Factors Engineering
    Cambridge Consultants
    Technology Development Manager
    Terumo Americas Holding, Inc
    Injectables, Sterile Manufacturing & Dev. Global Pharmaceutical Technology
    Allergan Inc
    Senior Director, Head PFS/ Primary Container Platform
    Sanofi S A
    Principal
    FDAPharma Consulting LLC
    Scientist II, Formulation Sciences
    MedImmune
    Manager of Quality & Statistical Engineering
    Genentech
    Senior Product Manager, PFS Platform
    West Pharmaceutical Services, Inc.
    Principal Engineer, Device Strategy
    Amgen
    Executive Director, Non-Clinical & Translational Sciences
    Allergan
    Human Factors Engineer
    Eli Lilly & Company
    Deputy Director Science and Policy, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices (DAGRID)
    FDA
    Product Manager
    Zeon Chemicals L.P.

    Sponsors and Exhibitors

    Official Publication

    Supporters

    A Written Interview with Melanie Turieo, Director, Human Factors Engineering, Cambridge Consultants

    Download

    Preliminary List of Attendees: Pre-Filled Syringes East Coast 2016

    Download

    A Case Study on Extractable and Leachables with Sanofi Pasteur

    Download

    An Interview with Zeon

    Download

    Lyophilisation Europe

    Download

    Extend Your Stay to Attend Lyophilization USA!

    Download

    Sponsors and Exhibitors


    Ajinomoto Althea Inc

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

    Ajinomoto Althea Inc, is a fully integrated contract development and manufacturing organization, providing clinical/commercial product development services, including production of microbial-derived recombinant proteins and plasmid DNA and cGMP filling in vials/syringes. Althea also offers process development, analytical development, complex formulation, release testing, and stability testing services. Learn more at www.altheacmo.com.


    Datwyler

    Sponsors and Exhibitors
    http://sealing.datwyler.com/

    Datwyler provides high-quality, system-critical elastomer components and has a leading position in the global healthcare market. Within the healthcare solutions business area, Datwyler develops, designs, and manufactures solutions for injectable packaging and drug delivery systems to facilitate customers to create a safer medical environment of tomorrow. Looking back onto more than 100 years of history, Datwyler is a reliable partner, now and in the future!


    FluentaOVLK

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

    FluentaOVLK believes in a better way to manufacture liquid products that is cleaner, safer, more flexible and efficient. Our line of innovative single-use fluid path products and services are anchored by our custom molded Freedom Filler Kits, which include all necessary fluid path components for increased liquid filling efficiency. We utilize precision fabricated components and industry leading single-use technology to provide end-users with custom solutions that solve challenging problems associated with liquid fill/finish processing. Visit our booth to view the latest product innovations in liquid fill/finish technology, including our patented Krimploc System, Single-use Filling Needles and Freedom Filler KIts.


    KBI Biopharma

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

    KBI also provides services from its industry-leading Particle Characterization Core Facility, including a full range of particle detection methods and data analysis utilizing MFI, Archimedes, NTA, Helix, Morphologi G3-ID, and Viscosizer instruments.


    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.


    Noxilizer

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

    Noxilizer, Inc. provides room temperature nitrogen dioxide sterilization technology. NO2 sterilization has shorter cycles (approximately 2 hours including aeration), operates with or without vacuum and is easily installed—an ideal solution for prefilled syringes and drug-device combination products. Noxilizer provides contract sterilization services and sells sterilization and decontamination equipment. The company has offices in the US, UK & Japan.


    Terumo

    Sponsors and Exhibitors
    https://www.terumopharmaceuticalsolutions.com

    Terumo Corporation, founded in 1921, is a global and innovative medical technology company of Japanese origin. Today – with almost 100 years of experience – Terumo offers you advanced technology for product design, development, quality management, manufacturing, logistics, customer service, and regulatory expertise. Our PLAJEX™ Ready-to-Fill polymer syringes have specific features that address several current issues with protein/peptide biopharmaceuticals, such as aggregation, viscous injection, and reduction of (sub-) visible particles. Among these features, PLAJEX™ syringes are steam sterilized and utilize proprietary i-coating™ technology, to provide a silicone oil-free platform for applications requiring low reactive containers. Terumo Corporation, “Innovating at the Speed of Life”.


    West Pharmaceutical Services

    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.


    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


    International Journal of Biomedical Engineering and Technology

    Official Publication
    http://www.inderscience.com/ijbet

    IJBET addresses cutting-edge research in the multi-disciplinary area of biomedical engineering and technology. Medical science incorporates scientific/technological advances combining to produce more accurate diagnoses, effective treatments with fewer side effects, and improved ability to prevent disease and provide superior-quality healthcare. A key field here is biomedical engineering/technology, offering a synthesis of physical, chemical, mathematical and computational sciences combined with engineering principles to enhance R&D in biology, medicine, behaviour, and health. IJBET includes the Asia-Pacific Chapter in Biomedical Wireless Technology (APC-BWT).


    Int. J. of Biotechnology

    Official Publication
    http://www.inderscience.com/ijbt

    IJBT provides an international forum and refereed authoritative source of information in the field of Biotechnology and Biotechnics, with emphasis on management and economics, as well as the political and social issues. It aims to disseminate knowledge, provide a learned reference in the field, and establish channels of communication between academic and research experts, policy makers and executives in industry, commerce and investment institutions.


    International Journal of Healthcare Technology and Management

    Official Publication
    http://www.inderscience.com/ijhtm

    IJHTM is a series emerging from the International Journal of Technology Management. It provides an international forum and refereed authoritative sources of information in the fields of the economics and management of technology in healthcare.


    International Journal of Environment and Health

    Official Publication
    http://www.inderscience.com/ijenvh

    IJEnvH is a fully-refereed scientific journal that provides an international forum for the exchange of information and the advancement of knowledge in the multidisciplinary field of environment and health. The aim of IJEnvH is to stimulate the discussion and communication among scientists, researchers and experts with different background and expertise, involved, at different levels, with the study of environment and health problems.

    Media Partners


    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.


    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/


    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.


    Pharmaceutical-tech.com

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

    Pharmaceutical-Tech : “In the realm of Pharmacy, where innovation is rapid, Pharmaceutical-Tech stands adept at conceptualizing unique ideas relevant to the B2B space. Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. Pharmaceutical-Tech.com covers in-depth trends that shape industry dynamics and metamorphose global economics. With services like search engine optimization, global magazine, social media marketing, product video showcase, e-mail marketing, e-newsletter sponsorship, banner advertising, event marketing and micro-website within our platform, www.pharmaceutical-tech.com has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.”


    http://www.fiercebiotech.com" target="_blank"> sponsor image

    FierceBiotech

    Supporters
    http://www.fiercebiotech.com" target="_blank" class="link" align="right"> http://www.fiercebiotech.com

    FierceBiotech is the biotech industry's daily monitor. Biotech executives rely on FierceBiotech to stay up to speed on biotech corporations, FDA approvals & regulations, industry mergers & acquisitions, clinical trials, and more. Beyond the news of the day, our editors produce in-depth features on industry leaders and up-and-comers, the regulatory environment, and market trends. In addition to our comprehensive website and free email newsletter, you have the opportunity to attend our webinars, peruse our whitepaper library and benefit from our eBooks. Advance your career through our exclusive networking parties and life sciences job board.


    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.


    CanBiotech

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    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.


    Inderscience Publishers

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    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.


    International Pharmaceutical Industry

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    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.


    Drug Development Technology

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    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.


    Pharmalicensing

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    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.


    Packaging-gateway

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    http://www.packaging-gateway.com

    Packaging executives from around the world use the website to keep abreast of the latest industry developments and make informed purchasing decisions along the entire supply chain. Packaging-gateway.com provides up-to-date industry intelligence through: •Regularly updated news bulletins and company press releases •Feature articles written by leading industry figures •Detailed research reports containing the latest market statistics •The latest packaging related projects •White papers containing the latest analysis, insights and technology solutions


    Pharmaceutical Outsourcing

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    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.


    Pharmacircle

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    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….


    Conference-Service.com

    Supporters
    http://www.conference-service.com/

    COMS is a web application for managing delegate registration, payment, paper submission and paper review. Written in Perl and C, with a MySQL database at the back end, it is a comprehensive and powerful, yet easy to use solution for online conference management.


    Pharma Marketing News

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    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.


    Farmavita

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    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!


    Absave

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    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!


    Technology Networks

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    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


    Bioscreening

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    http://www.bioscreening.com



    Pharmavision

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    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.


    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.


    SelectScience

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    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.


    Biosave

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    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.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    British Pharmacological Society

    Supporters
    http://www.bps.ac.uk

    The British Pharmacological Society (BPS) is the primary UK learned society concerned with research into drugs and the way they work. Our members work in academia, industry, regulatory agencies and the health services, and many are medically qualified. The Society covers the whole spectrum of pharmacology, including laboratory, clinical, and toxicological aspects. Clinical pharmacology is the medical speciality dedicated to promoting safe and effective use of medicines for patient benefit. Clinical pharmacologists work as consultants in the NHS and many hold prominent positions in UK Universities.


    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.

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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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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