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Pre-Filled Syringes East Coast
April 26 - April 27, 2017
Pre-Filled Syringes East Coast

SAE Media Group proudly presents their 4th annual Pre-Filled Syringes East Coast conference and exhibition, taking place this year on the 26th and 27th April in Boston, MA due to popular demand.


Pre-filled syringes are a great modern innovation in allowing patients to manage their conditions independently. Increase in chronic diseases, high competition between market providers, and drive for increased safety and ease for the self-administering of drugs, has made the pre-filled syringes market an dynamic and innovative one. Huge growth is forecast for the pre-filled syringe market in coming years.
With many factors at play here; regulation, manufacturing, safety assessment and combination products being just a few, navigating the pre-filled syringe industry can present complex challenges to success.

Join us in April at Pre-Filled Syringes East Coast to highlight and address the main challenges facing those working within the formulation, development, strategy and success of prefills. 

 This year’s agenda will provide regulatory guidance for the development of new devices, highlight common pitfalls and solutions to good manufacturing process, as well as highlight the emerging hot topics of the difficulties and considerations presented by biologic drugs and Human Factors.


Hear from industry leaders, regulatory experts and leading pharmaceuticals to understand and develop good strategy and practice of pre-filled syringes.

 

FEATURED SPEAKERS

Dhairya Mehta

Dhairya Mehta

Associate Director of Device and Combination Products, Shire
Edmond Israelski

Edmond Israelski

Director of Human Factors, AbbVie
Gary  Mills

Gary Mills

Associate Director, Drug Product Development , TESARO
Hemal Mehta

Hemal Mehta

Manager, Global CMC-RA, Medical Devices and Combination Products, Janssen Pharmaceutical Incorporated
Isabelle Delcroix

Isabelle Delcroix

Business Development Director, Nemera
Kenichiro Usuda

Kenichiro Usuda

Researcher, Advanced Business Development Division, MITSUBISHI GAS CHEMICAL COMPANY, INC
Michael  Selzer

Michael Selzer

Manager, Combination Products Engineering, Regeneron Pharmaceuitcals Inc
Steve Bowman

Steve Bowman

Leader, Device Center of Excellence, Shire US Inc
Sudeshna Dutta Ray

Sudeshna Dutta Ray

Senior Engineer Advanced Device Technology, Amgen Incorporated
Tiffnay McIntire

Tiffnay McIntire

Human Factors Engineer, Eli Lilly & Company
Toshiro Katayama

Toshiro Katayama

Product Manager, Zeon Chemicals L.P.

Adrien Tisserand

Category Manager - Parenteral, Nemera
Adrien Tisserand

Ann Peirce

Sales Manager - Pre-fillable Syringes, Nipro Pharma Packaging
Ann Peirce

Ms. Peirce graduated with a BS Degree from the University of Bloomsburg, PA in 1987.
Joining the Pharmaceutical Industry in 2002, she has been active in the pharmaceutical primary packaging field with growing responsibilities in various sales and business development roles.
Ms. Peirce joined Nipro PharmaPackaging in September 2013 as the sales manager for the SE United States and Eastern Canada. In April 2016 she was placed in her current role and is responsible for business development initiatives for Nipro’s pre-fillable glass syringe systems across North America.

David Chen

Vaccines Drug Product Development, Takeda USA
David Chen

Dhairya Mehta

Associate Director of Device and Combination Products, Shire
Dhairya Mehta

Edmond Israelski

Director of Human Factors, AbbVie
Edmond Israelski

Frank Janssen

Sales Director, Schreiner MediPharm
Frank Janssen

Frank Janssen is heading the North American Sales Organization of Schreiner MediPharm, being in charge of developing new markets and building strong customer and partner relationships. Frank joined Schreiner MediPharm in 2004 and held diverse positions in Global Key Account Management as well as Sales and Project Management at Schreiner MediPharm’s headquarters near Munich in Germany, before moving to the U.S. facility in Blauvelt, NY in June 2015. Prior to joining Schreiner MediPharm, Frank was Project Manager, dealing with industrial goods for the US market for five years. In addition, he was employed at the German American Chamber of Foreign Trade in Chicago, IL. Frank holds a degree in foreign economics.

Gary Mills

Associate Director, Drug Product Development , TESARO
Gary  Mills

Hemal Mehta

Manager, Global CMC-RA, Medical Devices and Combination Products, Janssen Pharmaceutical Incorporated
Hemal Mehta

Isabelle Delcroix

Business Development Director, Nemera
Isabelle Delcroix

Kenichiro Usuda

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

Li-Chun Tsou

Director, Devices and Combination Products, AbbVie
Li-Chun Tsou

Lloyd Waxman

Lead Research Scientist , West Pharmaceuticals Services Inc
Lloyd Waxman

Michael Selzer

Manager, Combination Products Engineering, Regeneron Pharmaceuitcals Inc
Michael  Selzer

Michael Selzer has over 15 years’ experience in the field of Pre-fillable syringes and injection devices in the biopharmaceutical industry. He is currently Manager of Combination Products at Regeneron Pharmaceuticals where he and his team are responsible for technical development and commercialization of Pre Filled syringes and Auto-injectors for novel biopharmaceutical products. Prior to Regeneron, Michael spent 11 years at Amgen in various roles supporting products in Pre-filled syringes, Lyophilized vials with reconstitution aids, and PFS based autoinjectors. These roles included technology transfer for drug product and packaging processes, method development for autoinjectors, glass breakage investigations, and device feasibility. He received his BS in Biology from San Diego State University and a Masters in Operations Management, also from San Diego State University.

Mike Price

Senior Engineer , Biogen Incorporated
Mike Price

Steve Bowman

Leader, Device Center of Excellence, Shire US Inc
Steve Bowman

Sudeshna Dutta Ray

Senior Engineer Advanced Device Technology, Amgen Incorporated
Sudeshna Dutta Ray

Tiffnay McIntire

Human Factors Engineer, Eli Lilly & Company
Tiffnay McIntire

Tina Kiang

Acting Director of CDRH/ODE/DAGRID, FDA
Tina Kiang

Toshiro Katayama

Product Manager, Zeon Chemicals L.P.
Toshiro Katayama

William Dierick

Director Technology Development, Terumo Europe
William Dierick

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Dhairya Mehta

Dhairya Mehta, Associate Director of Device and Combination Products, Shire

Michael Selzer, Manager, Combination Products Engineering, Regeneron Pharmaceuitcals Inc

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9:10

Regulatory considerations for combination products

Tina Kiang

Tina Kiang, Acting Director of CDRH/ODE/DAGRID, FDA

  • Regulatory considerations for combination products
  • Applicable regulatory schemes in the US and EU and some potential regulatory strategies
  • The latest revision of the FDA Combination Product Guidance
  • Changes in the FDA's quality system requirements for pre-filled injection devices
  •  

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    9:50

    Successful change control for patient centric drug delivery devices design and combination products post commercialisation market strategy

    Li-Chun Tsou

    Li-Chun Tsou, Director, Devices and Combination Products, AbbVie

    • When to initiate a design change or device change?
    • Which changes may require post regulatory submission? All changes should be assessed as design changes,  however not all device changes need to follow the full design control process
    • Implementing a change – changes to correct an existing problem may have unforeseen side effects on the device

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    10:30

    Morning Coffee & Networking break sponsored by Terumo

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    11:00

    The role of wearable devices in overcoming the challenges of delivering large-molecule and high-volume biologics

    Sudeshna Dutta Ray

    Sudeshna Dutta Ray, Senior Engineer Advanced Device Technology, Amgen Incorporated

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    11:40

    Tailoring the autoinjection with SAFELIA

    Isabelle Delcroix

    Isabelle Delcroix, Business Development Director, Nemera

     

    • For a better patient experience and for optimised drug delivery, including high volumes and high viscosities formulation
    • Safelia injection course can be adjusted to fit ’difficult’ formulations delivery, reconstitution, dual injections for subcutaneous or intra-muscular injections

     

     

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    12:20

    Networking Lunch sponsored by West Pharmaceutical Services

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    13:30

    Combination products: Clinical and quality considerations applicable to bridging principles

    Hemal Mehta

    Hemal Mehta, Manager, Global CMC-RA, Medical Devices and Combination Products, Janssen Pharmaceutical Incorporated

    • Bridging design verification and validation for pre-filled syringe supplier changes
    • Clinical bridging between Pre-filled syringes and injectors in and after Phase 3 trials – PK comparability risks
    • Bridging legacy product design history files to meet 21 CFR part 4 requirements

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    14:10

    A comparison of the stability of protein solutions in prefillable syringes made of glass or plastic under quiescent conditions and when subjected to mild agitation

    Lloyd Waxman

    Lloyd Waxman, Lead Research Scientist , West Pharmaceuticals Services Inc

    • Protein stability during long-term storage in glass vs plastic prefillable syringe systems
    • The effect of autoclave vs E-beam sterilization of COP prefillable syringes on protein degradation
    • Protein aggregation in prefillable syringes made of glass or plastic subjected to agitation stress
    • The importance of performing a stability study in primary container systems made of glass vs plastic to determine the optimal packaging material

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    14:50

    The use of Cyclo Olefin Polymers (COP) for syringe, vial and cartridge applications in the pharma industry

    Toshiro Katayama

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

    • Key properties and features of COP & its benefi ts for pre-fi lled syringe applications
    • Mechanical properties after exposure to gamma, steam, EOG and cryogenic temp
    • JP, US, EU Pharmacopoeia and ISO 10993 status
    • Extractable/leachable test data in COP syringes with various chemicals
    • Protein adsorption/aggregation study data with actual protein drugs to COP vs. glass
    • Delamination study data on glass syringe

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    15:30

    Afternoon Tea & Networking Break sponsored by Terumo

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    16:00

    Latest trends in smart and multi-functional labeling solutions for pre-filled syringes

    Frank Janssen, Sales Director, Schreiner MediPharm

    • Label-integrated needlestick prevention
    • Low migration labels and challenges of COC/COP materials
    • Innovative RFID/NFC solutions to improve user experience and patient safety

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    16:40

    Pre-filled syringe selection and the impact to life cycle management of drug products

    Steve Bowman

    Steve Bowman, Leader, Device Center of Excellence, Shire US Inc

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    17:20

    Panel Discussion: Combination products – challenges and opportunities

    Michael Selzer, Manager, Combination Products Engineering, Regeneron Pharmaceuitcals Inc

    Isabelle Delcroix

    Isabelle Delcroix, Business Development Director, Nemera

    Mike Price

    Mike Price, Senior Engineer , Biogen Incorporated

    clock

    18:00

    Chairman's Closing Remarks and Close of Day 1

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire

    Michael Selzer, Manager, Combination Products Engineering, Regeneron Pharmaceuitcals Inc

    clock

    9:10

    Navigating regulations surrounding Human factors

    Edmond Israelski

    Edmond Israelski, Director of Human Factors, AbbVie

    • Current regulatory climate, international and domestic
    • Updates from the IEC/ISO – what does this mean for assessing and approving devices globally
    • Other Human Factors standards – MHRA and AAMI – What is their impact

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    9:50

    The new paradigm of digital health and connectivity – From strategy to execution with compliance

    Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire

    • Data collecting from patient behaviour and smart devices
    • Exploring the connected drug delivery ecosystem; opportunities for feedback and monitoring
    • Moving forward with smart devices

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    10:30

    Morning Coffee & Networking Break sponsored by Terumo

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    11:00

    Patient centric designs for pre-filled syringes

    Tiffnay McIntire

    Tiffnay McIntire, Human Factors Engineer, Eli Lilly & Company

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    11:40

    PLAJEX™ with Safe ‘n’ Sound®: Safe delivery of biotherapeutics

    William Dierick

    William Dierick, Director Technology Development, Terumo Europe

    Adrien Tisserand

    Adrien Tisserand, Category Manager - Parenteral, Nemera

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    12:20

    Networking Lunch sponsored by West Pharmaceutical Services

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    13:30

    OXYCAPT Multilayer Plastic Vial & Syringe with glass-like gas barrier for oxygen sensitive biologics

    Kenichiro Usuda

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

    • Debating advantages of plastic syringes versus glass syringes
    • How to overcome disadvantages of existing plastic syringes
    • Latest studies for extractables from plastic and glass
    • Minimising oxygenation and external changes through materials and development strategies
     

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    14:10

    Criteria for pre-filled syringes CMO selection

    Gary  Mills

    Gary Mills , Associate Director, Drug Product Development , TESARO

    ·      CMOs are a critical component of the drug product development and commercial manufacturing supply chain for many bio/pharmaceutical companies.
    ·      The CMO must provide the specific manufacturing technologies, quality systems and regulatory support required to meet the drug product’s critical quality attributes and business goals.
    ·      Identifying and selecting the best CMO is essential to the success of any drug product program.

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    14:50

    Innovative technologies in the manufacturing process of glass pre-filled syringes

    Ann Peirce, Sales Manager - Pre-fillable Syringes, Nipro Pharma Packaging

    • Introduction of a laser-assisted glass cutting technology resulting in reduced glass particle count, mechanically stronger and more dimensionally stable finger flanges
    • Features and benefits of an innovative X-ray inspection unit addressing increasing regulatory requirements for CCI and for drug delivery systems safety

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    15:30

    Afternoon Tea & Networking Break sponsored by Terumo

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    16:00

    Challenges of Drug Delivery for Pediatric Patients: A Case Study

    Steve Bowman

    Steve Bowman, Leader, Device Center of Excellence, Shire US Inc

    clock

    16:40

    Panel Discussion: The future of parenteral drug delivery - moving from drug delivery devices to therapy management ecosystems

    David Chen

    David Chen, Vaccines Drug Product Development, Takeda USA

    Sudeshna Dutta Ray

    Sudeshna Dutta Ray, Senior Engineer Advanced Device Technology, Amgen Incorporated

    Dhairya Mehta

    Dhairya Mehta, Associate Director of Device and Combination Products, Shire

    clock

    17:20

    Chairman’s Closing Remarks and Close of Day Two


    Category Manager - Parenteral
    Nemera
    Sales Manager - Pre-fillable Syringes
    Nipro Pharma Packaging
    Vaccines Drug Product Development
    Takeda USA
    Associate Director of Device and Combination Products
    Shire
    Director of Human Factors
    AbbVie
    Sales Director
    Schreiner MediPharm
    Associate Director, Drug Product Development
    TESARO
    Manager, Global CMC-RA, Medical Devices and Combination Products
    Janssen Pharmaceutical Incorporated
    Business Development Director
    Nemera
    Researcher, Advanced Business Development Division
    MITSUBISHI GAS CHEMICAL COMPANY, INC
    Director, Devices and Combination Products
    AbbVie
    Lead Research Scientist
    West Pharmaceuticals Services Inc
    Manager, Combination Products Engineering
    Regeneron Pharmaceuitcals Inc
    Senior Engineer
    Biogen Incorporated
    Leader, Device Center of Excellence
    Shire US Inc
    Senior Engineer Advanced Device Technology
    Amgen Incorporated
    Human Factors Engineer
    Eli Lilly & Company
    Acting Director of CDRH/ODE/DAGRID
    FDA
    Product Manager
    Zeon Chemicals L.P.
    Director Technology Development
    Terumo Europe

    Sponsors and Exhibitors

    Official Media Partner

    Official Publication

    Supporters

    Workshops

    Slide Snippets - PFS East Coast 2017

    Download

    The Truth Behind Protein Aggregation in Prefilled Syringes

    Download

    Pre-Filled Syringes West Coast 2017

    Download

    Sponsorship Manual

    Download

    Q&A with Shire Ahead of Pre-Filled Syringes East Coast 2017

    Download

    An Interview with PFS East Coast Sponsors - SCHOTT Pharmaceutical Packaging

    Download

    PFS East Coast 2017 Preliminary Attendee List

    Download

    An Interview with Eli Lilly

    Download

    Sponsors and Exhibitors


    Bemis Healthcare Packaging

    Sponsors and Exhibitors
    http://www.bemis.com/healthcare-packaging

    Bemis Healthcare Packaging provides high-quality packaging solutions engineered to protect your cutting edge medical devices, sensitive drugs and sophisticated diagnostic systems. We specialize in the manufacture of co-extruded, laminated and flexible films, foil barrier laminations, pouches, bags, thermoformed trays, lids, labels, heat seal coated DuPont™ Tyvek® and medical grade paper.


    CSS (Connecticut Spring & Stamping)

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

    CSS (Connecticut Spring & Stamping) is a customer-focused advanced manufacturing company. We engineer and manufacture precision metal springs, stampings, metal forms and assemblies, especially for the medical device industry. Our experience ranges from auto-injectors and infusion devices, to surgical instruments, sensors and wearables. CSS facilities are ISO 13485 certified. Leading OEMs and CMOs partner with CSS for design assistance and consistent volume production.


    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!


    Economy Spring

    Sponsors and Exhibitors
    http://www.mw-ind.com/brands/economy-spring/

    Economy Spring, a division of MW Medical Solutions. Economy Spring is a manufacturer of advanced medical device components, including highly-engineered, precision metal components and assemblies such as springs, surgical sharps, needles, laser machined tubing, staples, titanium clips, and complex assemblies. The company deploys its end-to-end product lifecycle know-how and design expertise to shorten product development time and lower costs. Economy Spring’s 40-plus year track record helps deliver product reliability and performance in demanding surgical and drug delivery applications. The company is registered with the Food & Drug Administration and has ISO 9001 certified and ISO 13485 compliant quality processes.


    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.


    Fluid Imaging Technologies

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

    Fluid Imaging Technologies, Inc. manufactures industry-leading particle analysis instrumentation based on digital imaging technology. The FlowCam provides a method for automated detection and rapid characterization of protein aggregates in biologic drugs to help you meet regulatory requirements, boost productivity and ensure product quality and safety.


    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.


    Nipro PharmaPackaging

    Sponsors and Exhibitors
    http://www.nipro-group.com

    Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers. Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 35,000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharmaceutical Packaging industries.


    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.


    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.


    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.


    West Pharmaceutical Services, Inc.

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

    West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 net sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.


    ZEON

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

    ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media. They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns.

    Media Partners


    Colorado Bioscience

    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.


    Drug Development & Delivery

    Official Media Partner
    http://www.drug-dev.com

    Drug Development & Delivery is a print/online content provider that presents the latest scientific methods in drug development for professionals.


    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


    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.

    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).


    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.


    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.

    Media Partners


    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.


    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….


    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.


    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.


    Labhoo

    Supporters
    http://www.labhoo.com



    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.


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    Packaging-gateway

    Supporters
    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


    BioChem Adda

    Supporters
    https://www.biochemadda.com/

    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


    SelectScience

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

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


    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/


    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.


    Pharmaceutical Online

    Supporters
    http://www.pharmaceuticalonline.com

    The premier sourcing site for the pharmaceutical manufacturing industry – find industry information on critical environment, particle sizing, pharma process control, pharma material handling, tablet production, pharma sterilizing, pharma cleaning, pharma filtration, pharma packaging, pharma inspection, & much more. Use our supplier directory, product showcase, and offline search service to expedite your discovery of new products and services.


    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.


    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.


    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.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.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.


    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.


    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.


    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!


    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.”


    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.


    Farmavita

    Supporters
    https://farmavitar.com

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


    Copybook - Pharmaceutical

    Supporters
    http://www.copybook.com/pharmaceutical

    Copybook is a global business network with many pharmaceutical events, exhibitions and seminars. We encourage business-to-business transactions and work tirelessly to gain our customers new business contracts worldwide. You can add events, companies and associations for free. When you are a member, you can add your company to the events listed in order to encourage other visitors to arrange meetings and appointments at those events to facilitate new business contracts. Want to see how we can increase your business network and transactions? SIGN UP FOR FREE today! Copybook – Your Global Business Network


    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.


    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.


    Biosave

    Supporters
    http://www.Biosave.com

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


    Technology Networks

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

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


    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.


    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.

    The Colonnade Boston

    120 Huntington Ave
    Boston 02116
    USA

    The Colonnade Boston

    The Colonnade Boston Hotel is one of the most dynamic Boston boutique hotels. At long last, staying in this Back Bay hotel is hip and fun, with convention cast aside in favor of a sleek, edgy design brimming with stylish attitude and modern character. Discover exquisitely appointed accommodations at this Four Diamond hotel in the heart of everything. Take a short stroll to Fenway Park, the Museum of Fine Arts, and Copley Square Mall. Do lunch on Newbury Street -- eight blocks of historic 19th Century brownstones and fabulous salons, boutiques, and dining spots -- dubbed the “Rodeo Drive of the East.” Lounge by our sparkling Roof Top Pool, a sparkling penthouse party with a touch of Hollywood glamour, 11 stories up in the Boston skyline. Throughout your stay at our welcoming Boston luxury boutique hotel, you’ll enjoy thoughtful, genuine service delivered by a gracious staff.

    HOTEL BOOKING FORM

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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
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