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The global prefilled syringe market is estimated to reach $6.9bn by 2018. This figure is reflective of manufacturers striving to improve their technologies to meet the increasing number of biologic drugs reaching the market. The rising demand for prefilled syringes is driving the manufacturers to introduce improvements in technology and with the focus still on the safety for the user, innovation improvements for device development and ease of use for the patient are key areas to be addressed.

SMi’s leading prefilled syringes conference will focus on a number of hot talking points that will no doubt cause controversy and debate and on reflection open the floor to discussion in our breakout sessions. In addition, with a new competitive market just around the corner for biosimilars we look at this new session for 2015 in addition to the vision and benefit of lyophilisation in a prefilled syringe.

Click here to download Q&A series with Kabi, Beroe, Safermed Technologies

LISTEN to keynote addresses from the leaders in human factors engineering with expert input on reaching certain patient populations, considerations and compliance in device design and how can we ensure the drug product is administered safely and effectively
LEARN about the critical issues surrounding safety assessments of prefilled syringes from extractables and leachables to sterility and needle stick prevention requirements –NEW FOR 2015
ENHANCE your understanding of labelling and pricing considerations with the competitive market for biosimilars set to storm with patent expiries due
ASSESS the future of prefilled syringes with case study led presentations addressing the challenges faced with parenteral packaging innovations and reviewing the strategies needed to overcome the hurdles with importance insights into autoinjectors and pens
ADDRESS the use of lyophilisation in prefilled syringes, is this the future vision?
 

Those involved in the following:

Pharma Development, Engineering, Manufacturing Technology, Biopharma Operations, Regulatory Affairs, Parenterals, Packaging,  Formulation Aseptic, Device Development, Device Design, Labelling,
Manufacturing, Chemistry Manufacture Controls (CMC), Drug Delivery, Formulation & Aseptic Filling Technologies, Quality Assurance, Safe Medication Practice

Specific job titles can include: 

 

Principal Scientist, Associate Scientist, Group Leader, Team Leader, Senior Director, Senior Engineer, Parenterals, Device Development, Project Leader, Packaging Director
 

 

Conference programme

8:00 Registration & Coffee

8:30 Chairs Opening Remarks

8:40 The importance of the patient and how each individual differs

Edmond Israelski

Edmond Israelski, Program Manager, Abbott Laboratories

9:20 Success Criteria – How can the FDA’s requirements be met?

Natalia Mazaeva

Natalia Mazaeva, Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi-Aventis

  • Demonstrating safety and effectiveness in the hands of the user
  • Reviewing the design requirements for validation purposes
  • Are the customer requirements being met in design transfer?
  • Post –market surveillance – What observations can be made?
  • 10:00 End user needs and perspectives for device assembly

    Dena Flamm

    Dena Flamm, Product Manager, Bosch Packaging Technology

    End User Needs and Perspectives are critical for final device delivery. This poster presentation will address the injectable device trends and flexibility required for an assembly machine to adapt to new market challenges while incorporating the ‘Human Factor’. This presentation will also focus on recent Regulatory updates (11608) for Combination Products.

     The lecture will show:

    1. Injectable Device Trends
    2. Human Factor - Increased focus on safety, usability and handling studies
    3. Flexible standardized platforms to handle customized assembly of pens and auto-injectors
    4. Gentle handling of the filled glass container during assembly of the device using proven liquid fill finish handling technology.
     

    10:40 Morning Coffee

    11:10 KEYNOTE ADDRESS - Convenience and compliance: empower the user through good design

    Ben Bartfeld

    Ben Bartfeld, Human Factors and Industrial Design Consultant,

  • Reducing concerns by the end user is critical, what steps can be taken to increase patient satisfaction?
  • Precision and safety go hand in hand, let’s address considerations to ensure the product designed is safe and effective
  • How do we ensure the patient receives the exact dose intended?
  • 11:50 What makes a prefilled syringes ergonomic?

    Saikrishna Garrepalli

    Saikrishna Garrepalli, Procurement Management Representative , Beroe Inc

    12:30 The New Frontier: Advancing the Quality and Functionality of Drug Delivery

    Paul Chao

    Paul Chao, Core Team Leader, R&D Staff Engineer, BD Medical - Pharmaceutical Systems

    Justin M. Wright

    Justin M. Wright, Senior Director, Strategic Innovation, BD Medical - Pharmaceutical Systems

    13:10 Networking lunch

    14:10 Design Control and Tech Transfer Strategy to Deliver Patient-Centric Therapeutics

    Li-Chun Tsou

    Li-Chun Tsou, Global Device Technical Director, AstraZeneca

    14:50 Safety Evaluation of Leachables for Pre-Filled Syringe Drug Products

    Stephen Barat

    Stephen Barat, Senior Director, Toxicology and Operations, Actavis, Inc

  • Background on leachables and pre-filled syringes
  • Why safety assessment for leachables is necessary.
  • How to approach and conduct a leachable safety evaluation
  • Current best practice recommendations and examples
  • 15:30 Innovating for safety: let’s be sharp to protect end-users with safe injectable devices

    Isabelle Delcroix

    Isabelle Delcroix, Business Development Director, Nemera

    16:10 Afternoon Tea

    16:40 Case Study: Identifying incompatibility causes and challenges

    Kiran Singh

    Kiran Singh, Associate Director, Sandoz Pharmaceuticals

  • Design and development of a pre-filled syringe.
  • Assessing the clinical use setting and reflecting on the impact of incompatibility
  • Review of LAVs available commercially and assessing the fit with the luer lock of the pre-filled syringe
  • Addressing the clinical incompatibility issues and its regulatory impact
  • 17:20 Assessing the safety of needle devices

    Pei-Yang Phillip Hsu

    Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies

    18:00 Chairs Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairs Opening Remarks

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

    9:10 Getting to market: Regulatory perspective

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

  •  Defining a pre-filled syringe as a product or device and its impact on regulatory approval
  • Roadmap to approval for PFS’s and auto injectors
  • Role of combination products in personalized medicine
  • Insight into the FDA’s current thoughts
  •  

    9:50 Round Table Discussion - Discussing the safety challenges surrounding prefilled syringes

    Pei-Yang Phillip Hsu

    Pei-Yang Phillip Hsu, Chief Executive Officer, SaferMed Technologies

    Pharmaceutical industry’s perspectives:
    ·         Drug stability (minimize drug-syringe interactions by mitigating leachables and extractables, flakes (lamellae) or deposits, glass fragments, and lubricant particles)
    ·         Syringe durability
    ·         Cost
    Manufacturer’s perspectives:
    ·         Simplified manufacturing/assembly processes to mitigate batch variances
    ·         Consider stringent sterilization and packaging processes
    ·         Compliance of the mandatory "safety" PFS
    Healthcare industry’s perspectives:
    ·         Avoid needlestick injuries
    ·         User-friendly
    ·         Eco-friendly (minimum residual of medicine, recyclable device material)
     
     
    Patient perspectives:
    ·         User-friendly (convenience and safety in preparation and self-administration)
    ·         Eco-friendly (minimum residual of medicine, recyclable device material)
    ·         Price-friendly

    10:20 Room Temperature Sterilization of Prefilled Syringes

  • The need for sterilization of prefilled syringes to be administered in the sterile field
  • Sterilization using Nitrogen Dioxide for temperature sensitive products
  • Regulatory pathways for nitrogen dioxide sterilization
  • Evan Goulet

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

    11:00 Morning Coffee

    11:30 Case Study: The partnership reviewed between a pharmaceutical company and the manufacturer/supplier

    Shun  Ogawa

    Shun Ogawa, Research Manager, Mitsubishi Gas Chemical Company Inc.

  •  Overview of the relationship and how it was managed

  • An explanation on why the products have been developed

    Pharma
    Supplier
    ·         What worked
      (Existing Actions)
    Pharma companies sometimes use
    mono-layer plastic containers to prevent
    the below problems, but all of them don’t
    have enough oxygen barrier.
    ·         What worked
    (Existing solutions by suppliers)
    Some supplies provide mono-layer plastic containers instead of glass, but all of them don’t have enough oxygen barrier.
    ·         What could’ve been improved?
     (Existing Problems for Glass Container)
    -Breakage
    -Heavy Weight
    -Difficulty of disposal
     -Protein Adsorption
        -Inorganic Extractable, etc.
    ·         What could’ve been improved?
    -Oxygen Barrier
    ·         Moving forward, what would you have done differently?
          (Future actions)
         Some antioxidizing agent might be used for injectable drugs.
    ·         Moving forward, what would you have done differently?
    (Our solutions)
    -We developed an oxygen absorbing
    polymer.
    -We also developed 3 layers-containers.
    -The oxygen absorbing polymer is used for
    the middle layer
    -COP which is well-known as a high moisture
    barrier plastic, is used for the inner and outer
    layers.
  • 12:10 Combination Product Considerations- Starting with the End in Mind

    Royce Brockett

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

  • Evolving trends for the pre-filled syringe and self-injection markets
  • Industry/Supplier partnership is key to successful development outcomes
  • Patient considerations and building strong product brands through innovation
  • 12:50 Networking Lunch

    13:50 Round Table Discussion - The partnership reviewed between a pharmaceutical company and the manufacturer/supplier

    Witold Swiatek

    Witold Swiatek, Associate Director, Device Development, Merck Research Laboratories

    14:30 Product Line Management, sustaining activities

    Mark Tsai

    Mark Tsai, Principal Engineer, Drug Delivery, Johnson And Johnson

    15:10 Mitigating Risks of Syringe Variability in Devices

    Rob Schultheis

    Rob Schultheis, President, ZebraSci

  • Glass v Plastic
  • The advantages and disadvantages
  • Is once still more favourable, if so why? Discuss
  • 15:50 Afternoon Tea

    16:20 Case Study: Process Development studies to optimize process parameters and finalize presentation format

    Aarti Gidh

    Aarti Gidh, Principal Scientist, GlaxoSmithKline

    17:00 Electronics and Mobile Apps role in drug delivery and dosage adherence

    Chanderkanth  Gautham

    Chanderkanth Gautham, Domain Lead Medical Device Team, Beroe Inc

  • How electronics and mobile apps in device development are going to affect dosage areas in the medical device space
  • Some of major development in patch front which has circuitry embedment and other innovative add on
  • Increasing penetration of electronics in drug delivery
  • Vision of leading device manufacturers and their take on electronics future
  • Role of mobile apps in complimenting the growth of electronics in device arena
  • 17:40 Chairs Closing Remarks and Close of Day Two

    Ravi S. Harapanhalli

    Ravi S. Harapanhalli, Vice President and Former FDA Senior Executive, Parexel International

    +

    FEATURED SPEAKERS

    Aarti Gidh

    Aarti Gidh

    Principal Scientist, GlaxoSmithKline
    Ben Bartfeld

    Ben Bartfeld

    Human Factors and Industrial Design Consultant,
    Chanderkanth  Gautham

    Chanderkanth Gautham

    Domain Lead Medical Device Team, Beroe Inc
    Dena Flamm

    Dena Flamm

    Product Manager, Bosch Packaging Technology
    Edmond Israelski

    Edmond Israelski

    Program Manager, Abbott Laboratories
    Evan Goulet

    Evan Goulet

    Director, Sterilization Operations, Noxilizer, Inc.
    Isabelle Delcroix

    Isabelle Delcroix

    Business Development Director, Nemera
    Kiran Singh

    Kiran Singh

    Associate Director, Sandoz Pharmaceuticals
    Li-Chun Tsou

    Li-Chun Tsou

    Global Device Technical Director, AstraZeneca
    Mark Tsai

    Mark Tsai

    Principal Engineer, Drug Delivery, Johnson And Johnson
    Natalia Mazaeva

    Natalia Mazaeva

    Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi-Aventis
    Pei-Yang Phillip Hsu

    Pei-Yang Phillip Hsu

    Chief Executive Officer, SaferMed Technologies
    Ravi S. Harapanhalli

    Ravi S. Harapanhalli

    Vice President and Former FDA Senior Executive, Parexel International
    Royce Brockett

    Royce Brockett

    Senior Product Manager, West Pharmaceutical Services, Inc.
    Saikrishna Garrepalli

    Saikrishna Garrepalli

    Procurement Management Representative , Beroe Inc
    Shun  Ogawa

    Shun Ogawa

    Research Manager, Mitsubishi Gas Chemical Company Inc.
    Stephen Barat

    Stephen Barat

    Senior Director, Toxicology and Operations, Actavis, Inc

    Aarti Gidh

    Principal Scientist, GlaxoSmithKline
    Aarti Gidh

    Ben Bartfeld

    Human Factors and Industrial Design Consultant,
    Ben Bartfeld

    Chanderkanth Gautham

    Domain Lead Medical Device Team, Beroe Inc
    Chanderkanth  Gautham

    Dena Flamm

    Product Manager, Bosch Packaging Technology
    Dena Flamm

    Edmond Israelski

    Program Manager, Abbott Laboratories
    Edmond Israelski

    Evan Goulet

    Director, Sterilization Operations, Noxilizer, Inc.
    Evan Goulet

    Isabelle Delcroix

    Business Development Director, Nemera
    Isabelle Delcroix

    Justin M. Wright

    Senior Director, Strategic Innovation, BD Medical - Pharmaceutical Systems
    Justin M. Wright

    Kiran Singh

    Associate Director, Sandoz Pharmaceuticals
    Kiran Singh

    Li-Chun Tsou

    Global Device Technical Director, AstraZeneca
    Li-Chun Tsou

    Mark Tsai

    Principal Engineer, Drug Delivery, Johnson And Johnson
    Mark Tsai

    Natalia Mazaeva

    Sr. Usability Leader, Global Usability and Risk Management, Device Development, Sanofi-Aventis
    Natalia Mazaeva

    Paul Chao

    Core Team Leader, R&D Staff Engineer, BD Medical - Pharmaceutical Systems
    Paul Chao

    Pei-Yang Phillip Hsu

    Chief Executive Officer, SaferMed Technologies
    Pei-Yang Phillip Hsu

    Ravi S. Harapanhalli

    Vice President and Former FDA Senior Executive, Parexel International
    Ravi S. Harapanhalli

    Rob Schultheis

    President, ZebraSci
    Rob Schultheis

    Royce Brockett

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

    Saikrishna Garrepalli

    Procurement Management Representative , Beroe Inc
    Saikrishna Garrepalli

    Shun Ogawa

    Research Manager, Mitsubishi Gas Chemical Company Inc.
    Shun  Ogawa

    Stephen Barat

    Senior Director, Toxicology and Operations, Actavis, Inc
    Stephen Barat

    Witold Swiatek

    Associate Director, Device Development, Merck Research Laboratories
    Witold Swiatek

    Sponsors and Exhibitors

    Supporters

    Workshops

    Pre-Filled Syringes America 2015 Preliminary Attendee List

    Download

    Q&A with Fresenius Kabi, Beroe, Safermed Technologies

    Download

    Sponsors and Exhibitors


    BD Medical

    Sponsors and Exhibitors
    http://www.bd.com/products/categories/pharmaceutical/

    BD Medical - Pharmaceutical Systems is the partner of choice for the pharmaceutical industry. With innovative prefillable syringes, self-injection systems, safety systems and needle technologies, we offer an extensive selection of solutions designed to protect, package and deliver drug therapies. Our experts provide comprehensive system-based service and full product solutions.


    Bosch Packaging Technology

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

    Bosch Packaging Technology is the world leader in the design and manufacture of pharmaceutical production and processing equipment. Bosch’s wide portfolio allows Bosch to provide complete solutions for all of your filling needs. Whether it’s pen assembly, nested syringes, cartridges, or bulk vials or syringes Bosch has an Aseptic filling solution to match your needs.


    Ginolis

    Sponsors and Exhibitors
    http://ginolis.com/company-introduction

    Ginolis provides automation solutions for manufacturing, laboratories and end-user instruments for medtech, pharmaceutical and diagnostic companies. Ginolis also develops customer-specific disposable platform solutions for high-volume applications. The company is privately owned and headquartered in Oulu, Finland, with a subsidiary in Uppsala, Sweden and a sales and service site in San Diego, California.


    Mitsubishi Gas Chemical

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

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


    Nemera

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

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


    Nipro PharmaPackaging

    Sponsors and Exhibitors
    http://www.nipro-pharmapackaging.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 16 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform.


    Noxilizer

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

    Noxilizer, Inc. provides a proprietary room temperature nitrogen dioxide sterilization technology that offers many benefits over traditional methods. NO2 sterilization has shorter cycles (approximately 2 hours including aeration), operates with/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 equipment. Noxilizer Inc. was founded in 2004 and has offices in the US, United Kingdom, and Japan.


    Terumo

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

    Terumo Corporation is one of the world’s leading medical technology companies and operates in more than 160 nations. Terumo, founded in 1921, develops, manufactures and distributes a broad range of world-class medical devices including the supply of drug delivery/injection devices to the pharmaceutical industry. Terumo Global Pharmaceutical Solutions (GPS) offers the pharmaceutical and biotechnology industry unique solutions in medical technology. In addition to offering our valued products, our specialized team also provides customized and dedicated solutions designed to meet your specific requirements.


    West Pharmaceutical Services

    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.

    Media Partners


    Pharma Marketing News

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    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.


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    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.


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    BIOTECHNOLOGY-EUROPE.com is provided by BIOTECHNOLOGY WORLD, facilitates the exchange of information by promoting research within biotech sector. These include all participants in the sector such as government bodies, researchers, consumers, biotechnology companies, journalists and venture capital companies, biotech nationals organizations. Links and collaborations with other industrial networks add up to the BIOTECHNOLOGY-EUROPE`s own extensive database.


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    LabRoots is a free, social networking site that enables scientists, engineers, and other technical professionals to connect, collaborate with, and learn from each other. LabRoots fosters world-wide scientific communication and incorporates the newest social networking technologies. LabRoots allows scientists to connect with each other as they describe their research interests on a myriad of unique features and tools, discovering meaningful collaborations across geographic boundaries and fields of expertise.


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    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


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    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


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    PMR (www.pmrcorporate.com) is a British-American company providing market information, advice and services to international businesses interested in Central and Eastern European countries as well as other emerging markets. PMR's key areas of operation include business publications (through PMR Publications), consultancy (through PMR Consulting) and market research (through PMR Research ). Being present on the market since 1995, offering high international standards in projects and publications, as well as providing one of the most frequently visited and top-ranked websites, PMR is one of the largest companies of its type in the region.


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    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.


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    http://www.labbulletin.com

    Lab Bulletin is a free online resource for scientists and laboratory professionals where you can catch up on the latest news for laboratory products and services. You will find an extensive directory of laboratory suppliers and manufacturers enabling you to contact companies quickly and easily to request further information. Lab Bulletin also publishes four free monthly E-Newsletters keeping you up-to-date with all of the latest laboratory products and industry news directly to your inbox. We have dedicated E-Newsletters for Chromatography and Spectroscopy, Microscopy and Image Analysis, weekly Industry News updates and our monthly Lab Bulletin E-Newsletter sent out to over 29,000 readers worldwide. To request your free copy click here


    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.


    LatinNews

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    http://www.latinnews.com

    LatinNews has been at the forefront of respected political, economic, security and strategic analysis since 1967. Today LatinNews provides a comprehensive intelligence resource on 33 countries in Central America, Latin America and the Caribbean; covering political, security, economic and strategic issues. LatinNews is the de facto intelligence source for serious LatAm professionals and academics worldwide. FREE 10-day evaluation is available from: http://www.latinnews.com or send in your contact details via: http://www.latinnews.com/contact-us


    Bentham Science

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    http://www.benthamscience.com/

    Bentham Science Publishers is a major STM journal publisher of 116 titles and 200 plus open access journals and print/online book series (Bentham eBooks). Bentham Science answers the information needs of the pharmaceutical and biomedical research community. Leading journals include Current Drug Metabolism (Impact Factor 5.113) and Current Medicinal Chemistry (Impact Factor 4.859): FREE online journals and information: www.benthamscience.com


    Contract Biotechnology

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    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. We are an online R&D matching tool that connects Scientifics and organizations involved in discovery, development and delivery of new healthcare products with service and products providers worldwide. Life science information technology is undergoing a revolution. Part of that revolution involves new, unexplored business models, open innovation, open data and collaboration. If you have a project or idea that you would like to propose, develop or run, we can help. A New Collaboration Network Model for Discovery Research and Development • Effective Platform: the 95% • 5.000 registered users // > 15.000 Newsletter subscribers • Geographical background: 45,5% Europe / 37,5% North America / 16,5% Asia / 0,5% ROW • Professional background: Outsourcing Manager, Project Manager, CEO, Business Developer, CSO, Account Manager, Sales & Marketing People, Scientists, R&D. For further information, please visit our website www.contract-biotechnology.com


    Antibodies Online

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    http://www.antibodies-online.com

    antibodies-online.com facilitates researchers to find the appropriate antibodies for their respective research project. As an independent and multi-vendor marketplace for research antibodies and thanks to the cooperation with more than 130 different manufacturers, a large selection of Antibodies (over 700,000), ELISA Kits (over 130,000), Secondary Antibodies (17,000), Proteins (130,000), Peptides and Isotype Controls is available. By supporting the Independent Validation Initiative and the Resource Identification Initiative, antibodies-online.com also addresses the important topics of transparent product quality and scientific reproducibility. In addition scientists receive news and detailed information about the individual antibodies from databases such as the PubMed and others.


    Genetic Engineering News

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    http://www.genengnews.com

    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    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.


    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.


    PharmCast

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    http://www.PharmCast.com

    www.PharmCast.com is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. www.PharmCast.com brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit www.PharmCast.com and discover for yourself why it is so popular among professionals.


    Cutting Edge

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    http://www.cuttingedgeinfo.com

    Cutting Edge Information provides customized research and benchmarking reports to pharmaceutical, biotechnology and other life science companies. We provide off-the-shelf and customized research for key areas including medical affairs, clinical development, market access, regulatory affairs, marketing management, sales and HCP fair market value.


    Medical News Today

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    http://www.medicalnewstoday.com

    Medical News Today is the largest independent medical and health news site on the web - with over 10,000,000 monthly unique users it is ranked number one for medical news on all major search engines. Medical News Today is used by pharmaceutical, biotech and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted campaigns to HCPs, patients and caregivers. To find out how Medical News Today can help you to reach the right audience contact peter@medicalnewstoday.com or visit www.medicalnewstoday.com.


    Gate2Biotech

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    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.


    Bioportfolio Limited

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    http://www.bioportfolio.com

    BioPortfolio.com is a leading news, information and knowledge resource covering the global life science industries impacted by biotechnology. The site aims to provide the lay person, the researcher and the management executive with a single location to source core information on specific bio-related topics, to collate relevant data associated with each topic and to point the user to relevant knowledge resources


    Labsave

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    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/


    GBI

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    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.


    Farmavita

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    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    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….

    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, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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