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Lyophilization USA
November 16 - November 17, 2017
Lyophilization USA

SAE Media Group announces the return of its 3rd annual Lyophilization USA Conference to New Jersey on November the 16th- 17th November 2017

As biopharmaceuticals continue to dominate the market the need for greater shelf life and protein stability has increased. For many biological products lyophilization is a necessity and the technology is constantly advancing. As manufacturing demands increase the global lyophilization market for pharmaceutical and biotechnology products is expected to reach $2.66 billion by 2019* and this a trend that is likely to continue as we push the boundaries of biopharmaceutical formulation and transport. (Source: *http://bit.ly/2fkSDos)

One of the main challenges in pharmaceutical lyophilization continues to be the scale- up and the implementation of QbD protocols for the optimization of cycles. Several companies are researching and developing ways to facilitate commercial bulk lyophilisation of vaccines, protein and cells while also reducing costs.

Join us as we look at advances in lyophilizing technology, PAT tools, QbD and design space, strategies to enhance lyophilization formulation and innovative alternative to Lyophilization

FEATURED SPEAKERS

Anton Mangold

Anton Mangold

Managing Director, iQ-Mobil
Charlie Tang

Charlie Tang

Director, Formulation Development, Regeneron Pharmaceuticals
Eric Munson

Eric Munson

Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky
Kelly  Forney Stevens

Kelly Forney Stevens

Drug Product Development , GSK
Lokesh  Kumar

Lokesh Kumar

Associate Scientist, Genentech

Adam Viverette

Associate Director, Manufacturing, Science and Technology, Melinta Therapeutics Inc
Adam   Viverette

Andrea Weiland-Waibel

Managing Director, Explicat Pharma GmbH
Andrea  Weiland-Waibel

Anton Mangold

Managing Director, iQ-Mobil
Anton Mangold

Charlie Tang

Director, Formulation Development, Regeneron Pharmaceuticals
Charlie Tang

Eric Munson

Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky
Eric Munson

Guido Schmitz

Head of Packaging & Technology Innovation, Bayer Consumer Care
Guido  Schmitz

Jean-Francois Michiels

Senior statistician, Arlenda
Jean-Francois Michiels

Karen Bossert

President, KB Consulting
Karen  Bossert

Katherine Bowers

Scientist II, Fujifilm Diosynth Biotechnologies
Katherine  Bowers

Kelly Forney Stevens

Drug Product Development , GSK
Kelly  Forney Stevens

Lokesh Kumar

Associate Scientist, Genentech
Lokesh  Kumar

Melissa Lash

Scientist, Drug Product Development, Johnson And Johnson
Melissa  Lash

Pavol Rajniak

Principal Consultant, PROCESS SYSTEMS ENTERPRISE LIMITED
Pavol  Rajniak

Stefan Heindl

Business Development Manager, Coriolis Pharma
Stefan  Heindl

Sushma Kommareddy

Associate Director Formulation Development, Takeda
Sushma Kommareddy

sponsors

Conference agenda

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8:30

Registration & Coffee

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9:00

Chair's Opening Remarks

Andrea  Weiland-Waibel

Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

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9:10

Hydrogen Deuterium Exchange Mass Spectrometry for formulation/process optimization in lyophilized solids

Lokesh  Kumar

Lokesh Kumar, Associate Scientist, Genentech

  •  Basics of hydrogen deuterium exchange Mass Spectrometry (HDX-MS), for formulation and process optimization, will be briefly discussed
  • Impact of formulation parameters, i.e., protein: sucrose ratio, type of stabilizer etc. will be discussed
  • Impact of processing parameters, including controlled ice nucleation and annealing, on stress stability will be discussed. Correlation of HDX-MS data with stress stability would be performed to evaluate rank ordering of the impact of processing conditions
     
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    9:50

    Lyophilization process development, scale-up and technology transfer strategies

    Charlie Tang

    Charlie Tang, Director, Formulation Development, Regeneron Pharmaceuticals

  • Traditional approaches for process design, scale-up, and tech transfer
  • Impact of lyophilizer design on lyophilization process transfer and scale up
  • Challenges that can occur when implementing plans for large scale lyophilization
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    10:30

    Morning Coffee

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    11:00

    Holistic approach to packaging and innovative design

    Guido  Schmitz

    Guido Schmitz, Head of Packaging & Technology Innovation, Bayer Consumer Care

  • Case study on innovation in packaging of pharmaceuticals
  • challenges designing packaging that ensures patient safety and meets regulatory requirements
  • Relating consumer- friendly packaging to lyophilized products
     
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    11:40

    Tempris – how wireless product temperature monitoring is used in commercial lyophilization today

    Anton Mangold

    Anton Mangold, Managing Director, iQ-Mobil

  • Characterization and qualification of FDs
  • Determination of critical positions
  • Temperature data to evaluate the robustness of Lyo processes
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    12:20

    Networking Lunch

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    13:30

    Mathematical and experimental modelling for development and scale-up of lyophilisation cycles

    Pavol  Rajniak

    Pavol Rajniak, Principal Consultant, PROCESS SYSTEMS ENTERPRISE LIMITED

  • Inhomogeneous lyophilisation as a key challenge for development and scale-up of lyophilisation cycles
  • Development and calibration of mathematical models of different complexity by fitting to freeze-drying experimental data
  • Case Study 1 – a workflow for development and scale-up using a single vial approach
  • Case Study 2 – experimental and theoretical study of lyophilisation from a packing of vials
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    14:10

    Assessing phase separation in lyophilized protein formulation

    Kelly  Forney Stevens

    Kelly Forney Stevens, Drug Product Development , GSK

  • Understanding how and when phase separation occurs
  • Methods utilized to detect phase separation
  • Impact of formulation components and process parameters on phase separation
  • Significance of phase separation in lyophilized formulations
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    14:50

    Afternoon Tea

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    15:20

    Formulation strategies during clinical development

    Katherine  Bowers

    Katherine Bowers, Scientist II, Fujifilm Diosynth Biotechnologies

  • The biophysical tools required to understand a protein biopharmaceutical
  • Formulation design with uncertain dosage/delivery formats
  • Transitioning from frozen or liquid to lyophilized formulations
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    16:00

    Impact of controlled nucleation on physico-chemical properties and stability of lyophilized biologics

    Stefan  Heindl

    Stefan Heindl, Business Development Manager, Coriolis Pharma

  • Overview and comparison of different approaches for controlled nucleation
  • Application of controlled nucleation for low and high concentration protein formulations
  • Impact of controlled nucleation on physico-chemical properties of lyophilized biologics
  • Impact of controlled nucleation on protein stability
     
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    16:40

    Chair’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chair's Opening Remarks

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

    clock

    9:10

    Process validation for lyophilized drug products: Developing a program for continued process verification

    Karen  Bossert

    Karen Bossert, President, KB Consulting

  • Explore a series of classical approaches to data treatment to apply throughout all parts of the lyophilization process
  • What are the techniques used to evaluate product and process data from multiple batches of lyophilized drug product?
  • Presentation of data sets and case studies, of multi-batch monitoring
  • Understanding the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPS) for lyophilized drug products
     
  • clock

    9:50

    Tech transfer & scale-up challenges and considerations for lyophilized products

    Adam   Viverette

    Adam Viverette, Associate Director, Manufacturing, Science and Technology, Melinta Therapeutics Inc

  • Common challenges faced when executing a tech transfer & scale-up project
  • Considerations for a successful tech transfer & scale-up project
  • Integrating process, product & lyophilizer equipment
  • Case studies

     Session reserved

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    10:30

    Morning Coffee

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    11:00

    Optimization of primary drying cycles using mathematical modelling

    Melissa  Lash

    Melissa Lash, Scientist, Drug Product Development, Johnson And Johnson

  • Influence of annealing on resistance and primary drying for IGG molecules
  • Assessing the variables depending on product properties
  • Modelling Lyophilization processes to develop optimized cycles and scale-up strategies
     
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    11:40

    Lyocycle development and PAT based optimization

    Andrea  Weiland-Waibel

    Andrea Weiland-Waibel, Managing Director, Explicat Pharma GmbH

    A case study including modern lyo cycle process performance qualification leading to a PAT real time feedback system controlled lyo cycle for continued process verification

  • Analysis of critical quality attributes of a freeze-dried product
  • Related critical process and product parameters – The product temperature
  • Lyo robustness testing to establish process boundaries and the lyo cycle design space
  • Modern lyo process validation and the implementation into regulatory Lyophilization
     

     

  • clock

    12:20

    Networking Lunch

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    13:30

    Stability of sugar-protein lyophilized formulations: Evaluation of phase separation and mobility

    Eric Munson

    Eric Munson, Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky

  • Basics of solid-state NMR spectroscopy as a technique for evaluating phase separation and mobility in sugar-protein formulations
  • Impact of sugar crystallization, relaxation times, and phase separation on protein stability will be discussed
  • Comparison of micro-environmental protonation states using solid-state NMR spectroscopy and visible probes will be shown
     
  • clock

    14:10

    Combined empirical and statistical approach to screen lead excipient combinations for lyophilisation of live attenuated tetravalent dengue vaccine

    Sushma Kommareddy

    Sushma Kommareddy, Associate Director Formulation Development, Takeda

  • The talk will focus on a combination experimental approaches utilizing semi-empirical excipient screening
  • Statistical modeling using design of experiments (DOE)
  • Identify stabilizing candidate formulations for a lyophilized live attenuated Flavivirus vaccine candidate
     
  • clock

    14:50

    Afternoon Tea

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    15:20

    PANEL DISCUSSION: Batch process vs Continuous Process

  • What are the challenges with continuous freeze drying and how to overcome these
  • Methodology to reduce the processing time of the fundamental steps
  • Areas in need of innovation with regards to lyophilization
  • Eric Munson

    Eric Munson, Patrick Deluca Endowed Professor of Pharmaceutical Technology, University of Kentucky

    Jean-Francois Michiels

    Jean-Francois Michiels, Senior statistician, Arlenda

    clock

    16:00

    Design of Experiment to optimize freeze drying process with a small budget

    Jean-Francois Michiels

    Jean-Francois Michiels, Senior statistician, Arlenda

  • Introduction/Context of lyophilization optimization
  • Screening design
  • Augmented design
  • Process optimization
  • clock

    16:40

    Chair’s Closing Remarks and Close of Day Two


    Associate Director, Manufacturing, Science and Technology
    Melinta Therapeutics Inc
    Managing Director
    Explicat Pharma GmbH
    Managing Director
    iQ-Mobil
    Director, Formulation Development
    Regeneron Pharmaceuticals
    Patrick Deluca Endowed Professor of Pharmaceutical Technology
    University of Kentucky
    Head of Packaging & Technology Innovation
    Bayer Consumer Care
    Senior statistician
    Arlenda
    President
    KB Consulting
    Scientist II
    Fujifilm Diosynth Biotechnologies
    Drug Product Development
    GSK
    Associate Scientist
    Genentech
    Scientist, Drug Product Development
    Johnson And Johnson
    Principal Consultant
    PROCESS SYSTEMS ENTERPRISE LIMITED
    Business Development Manager
    Coriolis Pharma
    Associate Director Formulation Development
    Takeda

    Sponsors and Exhibitors

    Official Media Partner

    Official Online Media Partners

    Supporters

    Workshops

    Introduction to Design of Experiments
    Workshop

    Introduction to Design of Experiments

    Renaissance Woodbridge Hotel
    November 15, 2017
    Iselin, USA

    [ATTENDEE LIST] - PHARMA USA WEEK

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    [SPONSOR CONTENT] - SCHOTT_iQPlatformCPhI2017_US_final

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    Lyophilization USA 2016 Attendee List

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    [SPEAKER INTERVIEW] Kelly Forney Stevens, Drug Product Development, GSK Vaccines

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    Sponsors and Exhibitors


    Ellab

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

    Ellab is an industry leading manufacturer of wireless dataloggers and wired thermocouple validation systems used in the pharmaceutical industry. Outside of temperature sensors Ellab offers vacuum, pressure, CO2, and RH sensors. Specifically, for the lyophilization process, Ellab specializes in analyzing shelf and product temperatures within a full lyophilization cycle.


    Process Systems Enterprise

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

    PSE’s mechanistic modelling solutions result in more efficient R&D and more effective experiments, more rapid formulation screening, improved process and product designs, reduced scale-up and tech transfer risk, better capture and transfer of knowledge across the organisation. In addition to lyophilisation, PSE has solutions for synthesis, crystallization, milling, spray drying, granulation, in-vitro dissolution and in-vivo absorption. PSE is pioneering the emerging science of Systems-based Pharmaceutics with Eli Lilly, Pfizer, GSK and Roche, and is the leader of the £20.4m digital design ADDoPT project.


    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.


    Tempris

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

    iQ-mobil is the developer and manufacturer of the wireless and battery-free temperature measurement system Tempris. Tempris is used for real-time product temperature monitoring and controlling during lyophilization in order to optimize processes and make pharmaceutical production more cost-efficient. Tempris is a PAT-tool and available for all types of freeze dryers according to cGMP guidelines.


    W.L. Gore & Associates, Inc

    Sponsors and Exhibitors
    https://www.gore.com/products/industries/military

    Gore & Associates: Almost twenty years ago, Gore introduced what would be the first in the line of exciting innovations for pharmaceutical and biopharmaceutical customers—the GORE® LYOGUARD® Freeze-Drying Tray. Since then, we’ve developed many single- and multi-use products and process components—all with the express focus on improving the customer experience by applying our materials technology and engineering know-how to deliver step-change performance.

    Media Partners


    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.


    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.

    Media Partners


    PWTV

    Official Online Media Partners
    www.pharmaworld.tv

    The dedicated Audio Visual file sharing platform for the Pharmaceutical, Life Sciences and The Animal Health Industry. Use the power of Audio and Visual to give a clearer information to your clients. www.pharmaworld.tv

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    Pharmiweb

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    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.


    Conference Service

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    COMS is a web based system for managing delegate registration, payment, paper submission, review and the book of abstracts. It is a comprehensive and powerful, yet easy to use solution for online conference management including event planning and creation of the detailed agenda.


    Pharmalicensing

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    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    Pharmavision

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    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Medical Device Network

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    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.


    Drug Discovery Today

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    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.


    Absave

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    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    SelectScience

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

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


    Packaging-gateway

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    http://www.packaging-gateway.com

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


    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.


    American Laboratory

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    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.


    BioChem Adda

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    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!


    Drug Development Technology

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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.


    World Pharma News

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    http://www.worldpharmanews.com/



    Inderscience Publishers

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    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.


    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.


    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….


    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.


    Pharmaceutical-tech.com

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    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.”


    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.


    Journal for Clinical Studies – Your Resource for Multisite Studies & Emerging Markets

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    http://www.JforCS.com

    Published bi-monthly.JCS is a unique journal, dedicated to providing information to the global pharmaceutical, biotechnology, medical devices and contract research organisations. JCS details practical and theoretical operational procedures, challenges, validatory and regulatory guidelines when conducting trials on a multisite basis and particularly within the emerging markets, naïve patient population, and remote access areas. JCS provides country by country objectives and uniquely brings you experiences in therapeutic areas of Liver diseases, kidney diseases, insect borne diseases, malnutrition and under nutrition. JCS is led by a strong editorial advisory board sourced out for their experiences; you will get the most practical insight for your global studies. JCS invites you to join us, write for us, feature your experiences with us, advertise your capabilities with us, and ask our advisory board for suggestions and guidelines. Let us make health care available to all.


    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/


    Pharmaceutical Outsourcing

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    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Technology Networks

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

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


    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.

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

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

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

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

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




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