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Pre Filled Syringes America

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.

SAE Media Group’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

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

Conference agenda

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9:15

Registration & Coffee

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9:30

Introductions and Opening Remarks

Ravi S. Harapanhalli

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

Barry Sall

Barry Sall, Senior Regulatory Consultant, PAREXEL

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10:15

Session 1: Quality-by-Design in the development of drug delivery systems

Ravi S. Harapanhalli

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

Barry Sall

Barry Sall, Senior Regulatory Consultant, PAREXEL

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11:00

Session 2: Regulatory pitfalls to avoid

Ravi S. Harapanhalli

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

Barry Sall

Barry Sall, Senior Regulatory Consultant, PAREXEL

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11:30

Morning Coffee

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12:00

Session 3: New Combination product regulations and how to comply with them

Ravi S. Harapanhalli

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

Barry Sall

Barry Sall, Senior Regulatory Consultant, PAREXEL

clock

12:30

Session 4: How to accelerate approval through FDA

Ravi S. Harapanhalli

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

Barry Sall

Barry Sall, Senior Regulatory Consultant, PAREXEL

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13:15

End of Workshop

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13:45

Registration & Coffee

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14:00

Will drug delivery in coming days be an integral part of DDM

Areas Covered

-          Introduction on these developments
-          Some case studies indicating the inception of the trend
-          Will developments in non-invasive sensor based technologies and automatic modes of delivery increase inclination of patients and physicians to home care technologies.
-          Do acquisition of monitoring device companies by Medtech giants’ indicate bigger role of DDM platforms in future?

Saikrishna Garrepalli

Saikrishna Garrepalli, Procurement Management Representative , Beroe Inc

Chanderkanth  Gautham

Chanderkanth Gautham, Senior Research Analyst, Beroe Inc

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15:30

Afternoon Tea

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15:45

Will artificial pancreas penetration in the market pave way for non-conventional diabetic therapy?

Areas  to be covered

-Will the aforementioned platform challenge the conventional, glucose measurement and injection therapy to a significant amount?
-Does this mean that conventional modes insulin delivery via auto injectors, pen injectors now needs a massive scale up technology wise?
-Who are those technology pioneers that need special mention on their recent developments in same space?

Saikrishna Garrepalli

Saikrishna Garrepalli, Procurement Management Representative , Beroe Inc

Chanderkanth  Gautham

Chanderkanth Gautham, Senior Research Analyst, Beroe Inc

clock

17:30

End of Workshop

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8:00

Registration & Coffee

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8:30

Chairs Opening Remarks

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8:40

The importance of the patient and how each individual differs

Edmond Israelski

Edmond Israelski, Program Manager, Abbott Laboratories

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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?
  • clock

    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.
     
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    10:40

    Morning Coffee

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    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?
  • clock

    11:50

    What makes a prefilled syringes ergonomic?

    Saikrishna Garrepalli

    Saikrishna Garrepalli, Procurement Management Representative , Beroe Inc

    clock

    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

    clock

    13:10

    Networking lunch

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    14:10

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

    Li-Chun Tsou

    Li-Chun Tsou, Global Device Technical Director, AstraZeneca

    clock

    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
  • clock

    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

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    16:10

    Afternoon Tea

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    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
  • clock

    17:20

    Assessing the safety of needle devices

    Pei-Yang Phillip Hsu

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

    clock

    18:00

    Chairs Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairs Opening Remarks

    Ravi S. Harapanhalli

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

    clock

    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
  •  
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    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

    clock

    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.

    clock

    11:00

    Morning Coffee

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    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.
  • clock

    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
  • clock

    12:50

    Networking Lunch

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    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

    clock

    14:30

    Product Line Management, sustaining activities

    Mark Tsai

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

    clock

    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
  • clock

    15:50

    Afternoon Tea

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    16:20

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

    Aarti Gidh

    Aarti Gidh, Principal Scientist, GlaxoSmithKline

    clock

    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
  • clock

    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


    Principal Scientist
    GlaxoSmithKline
    Sr. Usability Leader, Global Usability and Risk Management, Device Development
    Sanofi-Aventis
    Chief Executive Officer
    SaferMed Technologies
    Vice President and Former FDA Senior Executive
    Parexel International
    Senior Product Manager
    West Pharmaceutical Services, Inc.
    Procurement Management Representative
    Beroe Inc
    Associate Director, Device Development
    Merck Research Laboratories
    Research Manager
    Mitsubishi Gas Chemical Company Inc.
    Senior Director, Toxicology and Operations
    Actavis, Inc
    Business Development Director
    Nemera
    Human Factors and Industrial Design Consultant
    Director, Sterilization Operations
    Noxilizer, Inc.
    Core Team Leader, R&D Staff Engineer
    BD Medical - Pharmaceutical Systems
    Senior Director, Strategic Innovation
    BD Medical - Pharmaceutical Systems
    Domain Lead Medical Device Team
    Beroe Inc
    Product Manager
    Bosch Packaging Technology
    Program Manager
    Abbott Laboratories
    Associate Director
    Sandoz Pharmaceuticals
    Global Device Technical Director
    AstraZeneca
    Principal Engineer, Drug Delivery
    Johnson And Johnson
    President
    ZebraSci

    Sponsors and Exhibitors

    Supporters

    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.drugdeliverysystems.bd.com

    As a partner of choice for the pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of ready-to-use drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems, self-injection systems and connected solutions that help ensure smooth delivery, regardless of drug complexity, viscosity and dosing volume.

    With an unbending emphasis on innovation and the highest level of technical expertise, BD Medical - Pharmaceutical Systems provides pharmaceutical and biotechnology companies with support and resources to help them achieve their goals. We support their product launch and life cycle management through sophisticated consultative, analytical and clinical services to help ensure drug compatibility and seamless systems integration, while accelerating time-to-market and reducing risk.

    More information available @ drugdeliverysystems.bd.com



    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
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

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


    Nipro PharmaPackaging

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

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


    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


    International Pharmaceutical Industry

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    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.


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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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    Pharmaceutical Outsourcing

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

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


    PharmCast

    Supporters
    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.


    Drug Development Technology

    Supporters
    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    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.


    LabRoots

    Supporters
    http://www.labroots.com/

    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.


    Bioportfolio Limited

    Supporters
    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


    American Pharmaceutical Review

    Supporters
    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


    Cutting Edge

    Supporters
    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.


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Lab Bulletin

    Supporters
    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


    LatinNews

    Supporters
    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


    Packaging-gateway

    Supporters
    http://www.packaging-gateway.com

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


    GenomeWeb

    Supporters
    http://www.genomeweb.com

    GenomeWeb LLC is an independent, privately-held online and print publisher based in New York. Since 1997, GenomeWeb has served the global community of scientists, technology professionals, and executives who use and develop the latest advanced tools in molecular biology research and molecular diagnostics.

    GenomeWeb’s editorial mission is to serve readers with exclusive, in-depth coverage of the technology, institutions, and scientists that make up the worldwide research enterprise of molecular biology. We operate the largest online news organization focused on advanced research tools in genomics, proteomics, and bioinformatics.

    GenomeWeb readers can be found in major biopharmaceutical companies, top research universities, biomedical institutes, and government laboratories.


    Antibodies Online

    Supporters
    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.


    Pharma Marketing News

    Supporters
    http://www.news.pharma-mkting.com/

    Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives. It is a service of the Pharma Marketing Network -- The First Forum for Pharmaceutical Marketing Experts -- which brings together pharmaceutical marketing professionals from manufacturers, communications companies, and marketing service providers for wide ranging discussions and education on a multitude of current topics. Pharma Marketing Network & Pharma Marketing News provide executive-level content coupled with permission-based e-marketing opportunities.


    Bentham Science

    Supporters
    http://www.benthamscience.com/

    Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here


    Medical News Today

    Supporters
    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.


    World Pharma Today

    Supporters
    http://www.worldpharmatoday.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!


    FierceVaccines

    Supporters
    http://www.FierceVaccines.com

    FierceVaccines is a free, weekly email briefing on the innovations revolutionizing the development and production of vaccines. Critical areas covered include vaccine research, funding, and manufacturing. In addition to our comprehensive website and free weekly email newsletter, you can gain insights into the inner workings of the vaccine industry through our webinars, whitepapers, and eBooks. Advance your career by searching our jobs board and attending one of our exclusive networking parties. Join the FierceVaccines community today!


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Medical News Today

    Supporters
    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.


    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.


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    Select Science

    Supporters
    http://www.selectscience.net/

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover impartial, expert opinion and trusted reviews about latest laboratory equipment and techniques; plus videos, application notes and science news from around the world. Become a member for free today.

    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.

    HOTEL BOOKING FORM

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

    GLOBAL CPD

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

    CPD Certificates

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

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    Contact SAE Media Group

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




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