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 SMi proudly presents its inaugural event of the premier Pre-Filled Syringes series to San Diego in June 2016! 

The prefilled syringes (PFS) market is poised to account for exponential growth and account for $6 billion revenue by the end of 2020.* The market has witnessed continual advancements in device design with enhanced safety and usability by patients through human factor engineering. Nonetheless, challenges surrounding biologic drug stability, manufacturing and competition from other drug delivery technologies remain key concerns amongst pharma and medical device manufacturers.

Emulating on SMi’s successful PFS series, we are bringing this must-attend event to the West Coast, where we will focus more on the innovative technologies. Join us today to discuss with your industry colleagues to accelerate PFS development!

*http://bit.ly/1PhR2Zy
 

San Diego has been known for being a hub of healthcare and biotech innovation center. As of 2013, San Diego has the second-largest biotech cluster in the US, below the Boston area and above the San Francisco Bay Area.

More than 400 biotech companies are homed in the region. Major companies like Neurocrine Biosciences and Nventa Biopharmaceuticals are headquartered in SD, while many other established biotech companies - including BD Biosciences, Biogen Idec, Merck, Pfizer, Celgene and Vertex, also have their offices and R&D facilities in the heart of area,  this provides the optimal setting for our premier Pre-Filled Syringes Conference & Exhibition, which you will meet like-minded Pre-Fillled Syringes experts at this meeting!

 

Through practical case studies from pharma and interactive discussions, you will:

• Learn about the A-Z of extractables and leachables to ensure a holistic PFS safety assessment
• Keep your patients at heart: embedding human factors into device design
• Update on new PFS material selection and innovation in device design for combination products
• Understand regulators’ expectations and adhere to strict visual and PFS manufacturing inspection standards
• Discuss, debate and benchmark against peers’ best practice to stay ahead of the competition
 


 

Selected audience include but are not limited to those working in the pharmaceutical, biotech and medical device industry with responsibilities in manufacturing, packaging, supply chain, device development and regulatory affairs.

SVP, VP, Chief, Director, Head, Principal of
• Prefilled Syringes
• Drug Delivery
• Device Development
• Global Product Management
• Human Factors
• Application/ Device Specialists
• Senior Packaging Engineers
• Finished Products & Medical Devices
• Device and Delivery Injectable
• Packaging
 

Accord Healthcare; Aguettant; Aptar Pharma; Astech Projects Ltd; Bayer Pharma; BD Medical - Pharmaceutical; Boehringer Ingelheim; Datwyler Pharma Packaging; F. Hoffmann La Roche; Fareva; FDA; Fresenius Kabi Austria GmbH; Galderma; Gerresheimer; Ginolis; GlaxoSmithKline; Guerbet; Hospira Inc; IPI (International Pharmaceutical Industry); Janssen; Komax Medtech; Medical Device Usability Ltd; MHRA; Mitsubishi Gas Chemical Company Inc.; Nemera; Neuroderm; Nipro; NNE Pharmaplan; Novartis Pharma AG; Novo Nordisk A/S; Noxilizer, Inc.; Owen Mumford; Pfizer; PharmaJet; Phillips - Medisize; PhotoCure ASA; Qualasept; Regeneron Pharma; Sanofi; Sandoz; Sartorius Stedim France Sas; SCHOTT AG; SiO2 Medical Products; Terumo Corporation; TEVA Pharmaceuticals; Vetter Pharma Fertigung GmbH & Co KG; West Pharmaceuticals Services Inc; ZEON CORPORATION and MANY MORE

Conference programme

8:00 Registration & Coffee

8:30 Chairman's Opening Remarks

Edmond Israelski

Edmond Israelski, Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices

Robert Schultheis

Robert Schultheis, President, ZebraSci, Inc.

8:40 Regulatory Updates – Navigating Global Expectations for Drug Delivery Systems

Suzette Roan

Suzette Roan, Regulatory Affairs CMC, Combination Products & Medical Devices, Biogen Inc

  • Requirements for regulatory approval - with particular focus on US and EU expectations
  • Verification testing vs. ICH M4Q delivery system suitability and compatibility
  • Risk-based control strategies and stability/shelf-life considerations
  • 9:20 Regulatory Hurdles and Challenges for Approval of Drug Delivery Devices

    Edmond Israelski

    Edmond Israelski, Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices

  • Dealing with inconsistencies in regulatory expectation: USA FDA - CDER (Drug Centre) vs CDRH (Device); EU EMA  - Notified body expectations
  • Simulated use versus actual use
  • Worst case scenarios
  • Delay between usability testing and user training if applicable
  • Risk analysis expectations (quantitative vs. qualitative)
  • 10:00 Safety Assessment and Regulatory Updates on Pre-Filled Syringes and Combination Products

    Tina Kiang

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

    Shannon Hoste

    Shannon Hoste, Human Factors Engineer , FDA

  • Regulatory paradigm for pre-filled syringes
  • Combination products - how pre-filled syringes are considered
  • Taking consumers and patients into consideration - human factors
  • Q&A
  • 10:50 Morning Coffee & Networking Break

    11:20 Why Do We Do Formative Studies for Pre-Filled Syringes?

    Lisa Nilsson

    Lisa Nilsson, Human Factors Manager, Teva Pharamceuticals

  • The use of a pre-filled syringe, is it as straight forward as we think?
  • Formative studies for generic products
  • Case study: Formative studies impact on combination product projects
  • 12:00 Application of Quality by Design (QbD) to Combination Product Development

    Jeffrey Givand

    Jeffrey Givand, Director of Device Development, Merck, Sharp & Dohme

  • Connectivity between Quality Systems Regulations (21CFR820) and QbD (ICH Q8/Q9/Q10) principles
  • QbD methodology as applied to combination product development
  • Opportunities to improve assurance of quality and minimize post-launch product performance issues through QbD
  • 12:40 Networking Lunch

    13:50 Primary Container Characterization for Perfect Fit with Drug Product and Devices

    Frederick  Gertz

    Frederick Gertz, Principal Researcher, ZebraSci, Inc.

    Drug delivery devices are made up of complex and delicate components which require a well-orchestrated balance in order to perform properly. Failures within devices have lead to costly product recalls as well as delays in product commercializations. Stalled device activations, long injection times, foreign particle contamination, and improper dosings are all symptoms of undetected problems during the production life cycle. Many factors are required to be analyzed which may necessitate the use of advanced statistical and data mining tools in order to correctly identify the root of the problem. Causes may include variations in plunger diameter and compressibility, variations in needle length and diameter, non-uniform barrel geometry, poor barrel siliconization, as well as variations in auto-injector spring forces. Early and proper characterization of these factors can simplify root cause analysis, expedite product development, as well as mitigate the risks of future recalls and commercial delays. This presentation outlines recommended methodologies for root cause investigations including required sample sizes, types of tests and their efficiency, and introduces new tools for use in statistical analysis.

    14:30 Syringes for the Sterile Field: Nitrogen Dioxide Sterilization as a Solution

    Evan Goulet

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

  • The NO2 sterilization process is designed to minimize impact on temperature- and pressure-sensitive drugs and biologics
  • Discussing load configuration, biological indication locations and process data
  • Container-closure system integrity demonstration via sterility and NO2 ingress testing
  • Single batch release process for clinical trials
  • 15:10 Afternoon Tea & Networking Break

    15:40 PLAJEXTM Polymer-Based PFS with a Tapered Needle for Use in Autoinjectors

    Kevin Constable

    Kevin Constable, Senior Director, Technology Development, Terumo Americas Holding, Inc

  • Application of PLAJEXTM polymer-based, silicone oil free, PFS in autoinjectors for sensitive, high viscous, therapeutics proteins
  • Mitigating risks of:
    > Degradation of proteins due to extractables
    > High break loose and glide forces from viscous products
    > Aggregation of proteins due to silicone oil
    > Breakage from high forces in spring and pneumatic based injectors
  • 16:20 Measuring H2O2 Residuals and Mitigating Product Exposure on Isolator and RABS Filling Lines

    Aaron Hubbard

    Aaron Hubbard, Process Development Engineer, Genentech

  • Sources and mechanisms of hydrogen peroxide uptake into drug product, including the impact of materials of construction decisions
  • Vapor phase hydrogen peroxide sensors available to the industry
  • Applicability of small-scale studies and mathematical modeling - case study on commercial support
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    17:15 Drinks Reception Sponsored by ZEBRASCI

    8:00 Registration & Coffee

    8:30 Chairman's Opening Remarks

    Dhairya Mehta

    Dhairya Mehta, Associate Director, Shire Inc.

    8:40 Enhancement in Drug Delivery Devices - From PFS to Advanced Devices

    Dhairya Mehta

    Dhairya Mehta, Associate Director, Shire Inc.

  • Paradigm shift in drug delivery
  • Invasive, minimally invasive to non-invasive techniques
  • Connected health, human factors
  • Future of the drug delivery systems
  • 9:20 The Next Generation of Auto Injectors and Pens to Support Combination Products

    Benir Ruano

    Benir Ruano, Vice President, Global Manufacturing & Technical Operations, Xeris Pharmaceuticals

  • Xeris combination product platform
  • G-pen synthetic glucagon peptide formulation in PFS with autoinjector product for hyperglycemia
  • Challenges with manufacturing a low volume, aseptically filled COP PFS
  • Challenges with an international drug device supply  chain
  • Challenges with producing synthetic peptide in low humidity environments
  • 10:00 Morning Coffee & Networking Break

    10:30 Key Properties of COP Update

    Toshiro Katayama

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

  • Case study: Protein adsorption data - COP vs. glass
  • Case study: Study on delamination with glass syringe vs. COP syringe
  • Leachable data on COP syringe with various chemicals
  • 11:10 Combination Products and Devices - Creating and Maintaining the Design History File

    Maria Toler

    Maria Toler, Senior Manager, Quality Assurance Technology and Innovation, Pfizer

  • Design controls for combination products
  • Factors to consider from early  development through commercialization
  • Considerations for autoinjectors and complex devices
  • 11:50 VHP Low Temperature Surface Sterilization of Delivery Devices Pre-Filled with Sensitive Drug Products: Applications, Benefits and Guidance to Implementation to Aseptic Packaging Process

    Juha Mattila

    Juha Mattila, Senior Product Manager, STERIS FINN-AQUA

  • Explain the process principle and steps of VHP (Vaporized Hydrogen Peroxide) low temperature surfaces terminal sterilization
  • Present and discuss benefits to sensitive packaged product quality and the packaging process via technical solution and application examples
  • Provide guidance on how to implement VHP sterilization process via feasibility testing and cycle development tests, and guidance in validation procedures to validate according to the ISO14937 standard
  • 12:30 Networking Lunch

    13:40 Trouble-Shooting Syringe Filling Equipment

    Paul Tyson

    Paul Tyson, Principal Engineer, Aseptic Filling & Packaging, Boehringer Ingelheim Pharmaceuticals Incorporated

  • Using visual inspection to help clearly define problem
  • Understanding the importance of set-up and communications in operation
  • Implementing equipment and procedural improvements to eliminate problem
  • 14:20 OXY-CAPT TM Multilayer Plastic Pre-Filled Syringe with Glass-Like Gas Barrier Polymer and COP

    Fumihiro Ito

    Fumihiro Ito, Researcher, MITSUBISHI GAS CHEMICAL COMPANY, INC

  • Introducing ‘OXY-CAPTTM Multilayer Plastic Syringe’ made of glass-like gas barrier polymer and COP

  • Update on oxygen barrier study of OXY-CAPTTM syringe

  • Key benefits and features of OXY-CAPTTM syringe comparing to COP monolayer and glass syringe

  • 15:00 Afternoon Tea & Networking Break

    15:30 Novel Inspection Technology for Screening Particles in Drug Product

    Hoang  Nguyen

    Hoang Nguyen, Software Engineer, ZebraSci, Inc.

  • Imperative detection and characterization of free-floating foreign or condensed particles on drug product containers which may be hazardous to end users
  • How to prevent defective or contaminated products from reaching market
  • Improve your manufacturing process for pre-filled syringe and medical device through novel inspection technology
  • 16:10 Challenges of Pre-Filled Syringes Manufacturing

    Jennifer Vandiver

    Jennifer Vandiver, Senior Process Scientist, Alkermes

  • Importance of plunger placement control in pre-filled syringes
  • Qualification of automated pre-filled syringe assembly
  • Design transfer and verification of pre-filled syringe combination products
  • 16:50 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Edmond Israelski

    Edmond Israelski

    Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices
    Maria Toler

    Maria Toler

    Senior Manager, Quality Assurance Technology and Innovation, Pfizer
    Toshiro Katayama

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.

    Aaron Hubbard

    Process Development Engineer, Genentech
    Aaron Hubbard

    Benir Ruano

    Vice President, Global Manufacturing & Technical Operations, Xeris Pharmaceuticals
    Benir Ruano

    Dhairya Mehta

    Associate Director, Shire Inc.
    Dhairya Mehta

    Edmond Israelski

    Former Director Human Factors; Co-Convener, Abbvie; ISO/IEC Joint Working Group on Usability Standards for Medical Devices
    Edmond Israelski

    Evan Goulet

    Director, Sterilization Operations, Noxilizer, Inc.
    Evan Goulet

    Frederick Gertz

    Principal Researcher, ZebraSci, Inc.
    Frederick  Gertz

    Fumihiro Ito

    Researcher, MITSUBISHI GAS CHEMICAL COMPANY, INC
    Fumihiro Ito

    Hoang Nguyen

    Software Engineer, ZebraSci, Inc.
    Hoang  Nguyen

    Jeffrey Givand

    Director of Device Development, Merck, Sharp & Dohme
    Jeffrey Givand

    Jennifer Vandiver

    Senior Process Scientist, Alkermes
    Jennifer Vandiver

    Juha Mattila

    Senior Product Manager, STERIS FINN-AQUA
    Juha Mattila

    Kevin Constable

    Senior Director, Technology Development, Terumo Americas Holding, Inc
    Kevin Constable

    Lisa Nilsson

    Human Factors Manager, Teva Pharamceuticals
    Lisa Nilsson

    Maria Toler

    Senior Manager, Quality Assurance Technology and Innovation, Pfizer
    Maria Toler

    Paul Tyson

    Principal Engineer, Aseptic Filling & Packaging, Boehringer Ingelheim Pharmaceuticals Incorporated
    Paul Tyson

    Robert Schultheis

    President, ZebraSci, Inc.
    Robert Schultheis

    Robert Schultheis, President and Founder, has more than 15 years of experience working in the pharmaceutical and biotechnology industries. His primary role is to develop and commercialize new technology for inspection systems andservices related to primary drug packaging and devices. He guides the global vision for the company and is responsible for ZebraSci’s ongoing success and new product development.

    Prior to founding ZebraSci, Inc. Rob was involved in product development and continuous process improvement at Amgen, Merck and GlaxoSmithKline. Rob received his Bachelor of Science and Master’s degrees in Mechanical Engineering from Drexel University.
     

    Shannon Hoste

    Human Factors Engineer , FDA
    Shannon Hoste

    Suzette Roan

    Regulatory Affairs CMC, Combination Products & Medical Devices, Biogen Inc
    Suzette Roan

    Tina Kiang

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

    Toshiro Katayama

    Product Manager, Zeon Chemicals L.P.
    Toshiro Katayama

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Workshops

    Human Factor Engineering for PFS and Autoinjectors
    Workshop

    Human Factor Engineering for PFS and Autoinjectors

    Hyatt Regency Mission Bay
    8th June 2016
    San Diego, USA

    Site Visits

    Brewery Visit & Beer Flight Sponsored by ZEBRASCI
    Site Visit

    Brewery Visit & Beer Flight Sponsored by ZEBRASCI

    Stone Brewing World Bistro & Gardens - Liberty Station
    8th June 2016
    San Diego, USA

    VENUE

    Hyatt Regency Mission Bay

    1441 Quivira Road, San Diego, California, USA

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

    An unparalleled choice for discerning travelers, you’ll find everything you could wish for at our premier Mission Bay hotel near famous San Diego,CA attractions such as SeaWorld San Diego.

    HOTEL BOOKING FORM

    Preliminary Event Attendee List - Pre-Filled Syringes West Coast 2016

    Download

    Past Attendees List Pre-Filled Syringes US Series

    Download

    TERUMO Whitepaper: Functional Evaluation and Characterization of a Newly Developed Silicone Oil-Free Prefillable Syringe System

    Download

    Speaker Interview: Lisa Nilsson, Human Factors Manager, Teva Pharmaceuticals

    Download

    Sponsor Manual: Pre-Filled Syringes West Coast

    Download

    Sponsors and Exhibitors


    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.


    DDL

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

    DDL is a full-service testing lab that has provided package, product and materials testing to the medical device industry for over 25 years. DDL’s team of engineers, technical and quality experts is devoted to helping customers worldwide succeed by taking an independent, involved and informed approach to ensuring regulatory compliance.


    KBI Biopharma

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

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


    Mitsubishi Gas Chemical

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

    MGC is a leading company in the field of oxygen barrier and absorbing technology. Based on the existing experiences, MGC has successfully developed multilayer plastic vial and syringe. They have the characteristics of extremely high oxygen and water vapor barrier and others. MGC recommends using them for oxygen-sensitive drugs.


    Noxilizer

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

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


    STERIS

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

    For over 100 years STERIS Corporation has been known as a global leader, trusted partner and solutions provider in the field of sterilization and contamination control. From Formulated Chemistries, to Capital Equipment to Parts and Services, STERIS Life Sciences is Science and Solutions for Life.


    Terumo

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

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


    Zeon Chemicals L.P.

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

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

    Media Partners


    ONdrugDelivery Magazine

    Official Media Partner
    http://ondrugdelivery.com

    ONdrugDelivery Magazine is the highly regarded, world-leading series of sponsored themed drug delivery publications. Uniquely, each issue focuses tightly on one topic within the field of drug delivery. With a truly global readership already in excess of 40,000, and with contributions and loyal support from many of the most important companies in the drug delivery business - from among the largest to the smallest - ONdrugDelivery Magazine is a must for those in the industry who need to know what's going on in drug delivery.


    BioChem Adda

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

    BioChem Adda started in 2016 keeping in mind the needs of young aspirants from BioSciences and Chemistry. Recent discoveries and inventions have made this Biosciences and Chemistry domain more appealing to the ever-growing pool of students, academics, professionals and even to the general public. BioChem Adda runs World’s fastest growing Career and Educational Info Portal in the Biosciences and Chemistry domain. We offer you the ability to search through and register for various career opportunities (Ph.D. positions, Postdoc positions, Faculty positions, Scientist positions, Industrial Jobs, and Group Leader).

    Media Partners


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com

    American Pharmaceutical Review is the leading review of business and technology for the pharmaceutical industry throughout North America. Each issue offers unbiased editorial on drug delivery, information technology, research & development, analytical development and control, equipment and facility manufacturing and regulatory affairs. American Pharmaceutical keeps its 30,000 readers including senior executives, technical personnel, scientists, and others fully abreast of the latest trends and developments in the process of pharmaceutical manufacturing.


    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.


    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.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare is the most comprehensive, in-depth, and objective website for life science product information. Thousands of scientists use Biocompare daily to quickly find the right product for their experiments rather than looking through multiple print catalogs. Visit Biocompare to find the products you need, stay informed of new technologies, read product reviews, watch product videos, and keep up-to-date on life science news. Visit: www.biocompare.com


    International Journal of Biotechnology

    Supporters
    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.


    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


    Technology Networks

    Supporters
    http://www.technologynetworks.com

    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


    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!


    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.


    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.


    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.


    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 Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.


    Bioscreening

    Supporters
    http://www.bioscreening.com



    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

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


    International Journal of Environment and Health

    Supporters
    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.


    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.


    Pharmatching.com

    Supporters
    http://pharmatching.com

    Pharmatching.com is an efficient, targeted and easy-to-use-“Web2.0”-tool for finding the right partners in the pharmaceutical industry worldwide. It saves time and costs in all (out)sourcing and business development processes, as it fascilitates and accelerates the searching process for appropriate business partners significantly. Pharmatching.com is particularly advantageous for projects where a special service is (immediately) required or to offer capacities which are currently available. It is useful for services in all categories and stages of drug development including contract manufacturing, contract research, laboratory investigations, contractual testing, non-clinical and clinical research, active pharmaceutical ingredients, consulting, marketing, registration, in- and outlicensing etc.


    International Journal of Healthcare Technology and Management

    Supporters
    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.


    Packaging Europe

    Supporters
    http://packagingeurope.com

    PackagingEurope.com is the leading information supplier for and about the European packaging industry. It delivers daily pan-European packaging news and authoritative comment and analysis across multiple media, along with Packaging Network – an interactive networking tool and contact database – newsletters and market intelligence products.


    Drug Discovery Today

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    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Labsave

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    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/


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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.


    International Journal of Biomedical Engineering and Technology

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    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).

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    Hyatt Regency Mission Bay

    1441 Quivira Road
    San Diego 92109
    USA

    Hyatt Regency Mission Bay

    Experience the epitome of California coastal chic at Hyatt Regency Mission Bay Spa and Marina San Diego vacation resort near SeaWorld San Diego. Expect the best at this remarkable San Diego vacation resort offering incredible ocean views, waterfront dining, a contemporary poolside lounge, eco-friendly spa, and redesigned hotel rooms and suites and meeting rooms. The only resort hotel in San Diego with multiple water slides, you'll delight in a water playground with three new pools, waterfront health club, and a full-service marina with jet skis, sailboats, kayaks, sportfishing and whale excursions.

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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, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, United Kingdom, Link to Map
    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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