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SMi are proud to announce the 7th Pre Filled Syringes East Coast conference taking place on 27th and 28th April 2020.

The global pre-filled syringes market was valued at $4.9 billion in 2018 and with the rapid growth of the industry, is expected to exceed $9.7 billion by 2025. With that in mind, this event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry.

This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry.

Following the success of last year’s event, the upcoming conference will cover key topics driving the industry including: 

  • Container Closure Interaction and Formulation
  • On-body Injectors
  • Digital connectivity in the parenteral space
  • A regulatory outlook with industry and recognised body experts
  • Patient centricity and device development
  • Developments in device technology
  • Parenteral gene therapy
  • New for 2020: PFS Interactive Workshop Day

 

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.


We look forward to welcoming you to the conference in April.
 

  • EXPLORE the latest case studies parenteral drug delivery
  • GAIN insights into the use of pre-filled syringes for gene therapy
  • NETWORK with leading industry experts, key opinion leaders and regulatory body representatives
  • ENGAGE in the key challenges and topics of the field in the interactive post-conference workshop day

 

 

  • Drug-delivery developers
  • Medical Device Engineers
  • Primary Packaging material designers
  • Secondary packagers
  • Smart device developers
  • Training device developers
  • Device-safety solution providers
  • Drug developers
  • Previous attendees include:

3P Innovation Ltd; Alexion Pharmaceuticals; American Regent Inc; Amgen; Amgen Incorporated; Aptar Pharma; AstraZeneca; BCM Group LLC; BD / Becton, Dickinson and Company; Biogeneral Incorporated; BMS; Bristol Myers Squibb; Bristol-Meyers Squibb; Bristol-Myers Squibb; Celanese Corporation ; Celgene; Connecticut Spring & Stamping; Credence MedSystems, Inc.; Elektrofi; Eli Lilly and Company; Emd Serono; FDA; Ferring Pharmaceuticals; Flexion Therapeutics; Gerresheimer; Grifols; GSK; GSK Pharma; Harro Hofliger Verpackungsmaschinen GmbH; Imbrium Therapeutics; Janssen; Janssen Pharmaceutical Incorporated; Janssen Supply Chain, Johnson & Johnson; kaleo, Inc.; Key Tech; Kiniksa Pharmaceuticals; Lonstruff AG; MedImmune; Merck; Mitsubishi Gas Chemical Company, Inc; Mitsubishi Gas Chemical Singapore Pte Ltd; Momenta Pharmaceuticals; Nipro PharmaPackaging; NN Life Sciences; Nypro; Owen Mumford; Pfizer; Pfizer Inc; Pfizer Inc.; Pharmacircle; PHC Corporation of North America; Plastic Ingenuity Inc; Polyplastics, USA; Purdue Pharma; Regeneron Pharmaceuticals; RheoSense, Inc; Sagentia Ltd; Sanofi; Sanofi Pasteur; Sanofi Pharmaceuticals; Sanofi US; Schott AG; SCHOTT AG - Pharmaceutical; Smithers Rapra; Steri-Tek; Sumitomo Rubber; Takeda; Takeda Pharma Ceuticals International; Terumo Solutions; Teva Pharmaceuticals; Topas Advanced Polymers; Uhlmann; W.L. Gore & Associates, Inc.; West Pharmaceutical Services; zebrasci inc; Zeon Specialty Materials ; Zeon Specialty Materials Inc;

Conference programme

8:00 Registration & Coffee

9:00 Chair's Opening Remarks

Michael Song

Michael Song, Sr. Manager, AstraZeneca

9:10 Wearable and Digital Devices – a hybrid view between pharmaceutical and medical devices

Michael Song

Michael Song, Sr. Manager, AstraZeneca

• How lessons learned from medical device can help with wearable device development
• Electronics, batteries, and IEC requirements – let’s not reinvent the wheel
• Testing approach for novel / unique devices
 

9:50 Digital Health: The Evolving Regulatory Landscape

Krystin Meidell

Krystin Meidell, Manager, Biogen Idec

• Overview of recent changes in regulation and guidance
• Case Study: Connected Integrated Injector
• Case Study: Sensor/App for Inhaler
• Case Study: Dose Calculator App
 

10:30 Morning Coffee - Sponsored by Zeon

11:00 Simulation Driven analysis in Product development

Lin Li

Lin Li, Senior Consultant Engineer, Eli Lilly and Company Ltd

• Cloud based Numerical simulation.
• Scripted simulation to achieve design optimization
 

11:40 Challenges and Opportunities in Developing a System-Wide Stability Program for Combination Products

Alie Jahangir

Alie Jahangir, Senior Manager Combination Products and Emerging Technologies, Janssen

• Combination Products
• Stability Indicating Attributes
• Design Control process
• End-to-End Stability
• Drug/Biologics- Device Interactions
 

12:20 Consideration for defining the administration procedure for nano-dose drug in clinical studies

Michael Zhou

Michael Zhou, Investigator, GSK Pharma

• Adsorption phenomenon
• Dose recovery considerations
• Mitigation strategies
 

13:00 Networking Lunch

14:00 Technical Overview of COP for Prefilled Syringes

Larry Atupem

Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials

  • Key properties of COP
  • Case Study (New):
  • Protein Adsorption of Abatacept – COP vs Glass
  • Immunogenicity test of the aggregates 
  • Case Study: Protein Adsorption of Humira, Embrel, Remicade – COP vs Glass
  • Case Study: Protein Adsorption with/without Polysorbate (Surfactant) – COP vs Glass
  • Leachable data on COP syringes
     
  •  

    14:40 Combination Product Risk Management

    Tanner Barnes

    Tanner Barnes, Design Control Engineer II, Pfizer Inc.

    • Introduction of ICH Q9 and ISO 14971
    • Challenges of completing a comprehensive Hazard Analysis for combination products
    • Design Risk Assessments for off the shelf components
    • Integrating current drug development risk assessments to meet ISO 14971 compliance
     

    15:20 Qualification and validation of VH2O2 industrial low temperature terminal sterilizer process and equipment - Case study on process control and monitoring

    Juha Mattila

    Juha Mattila, Director, Sterilisation Technologies, STERIS Corporation

  • Brief introduction to VH2O2 sterilization process, technology and applications
  • Discuss validation and meeting ISO14937 standard requirements - and looking at the scenario of future VH2O2 specific standards
  • Present the essential process variables forVH2O2 sterilization
  • Case study on testing and comparing performance of various hydrogen peroxide concentration measurement methods – and proposing an applicable approach

     

  • 16:00 Afternoon Tea - Sponsored by Zeon

    16:20 Topic Heading 8

    16:30 A Regulatory Outlook and Update of the Combination Product Industry

    Tina Kiang

    Tina Kiang, Acting Director, FDA

    • Affect of TPLC re-organization in CDRH on combination product review (premarket and compliance)
    • New guidance updates
     

    17:10 EU MDR Impact on Premarket Regulatory Requirements for Combination Products

    Heather  L. Guerin

    Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen

  • Overview of new requirements of EU MDR Article 117, which could result in significant changes in practice, and potential impact to product development timelines
  • Collaborations between industry regulatory networks and EMA and Notified Bodies to clarify requirements
  • Discussion of recognized issues in interpreting Article 117 requirements and potential paths forward to meet new requirements
     
  • 17:50 Chair’s Closing Remarks and Close of Day One

    Michael Song

    Michael Song, Sr. Manager, AstraZeneca

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Michael Song

    Michael Song, Sr. Manager, AstraZeneca

    9:10 Combination Products Integrated Development

    Susan Neadle

    Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson

  • Combination Products Regulations are evolving globally.
  • One consistent undercurrent to this dynamic regulatory environment is the drive for successful practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs.
  • In this presentation we’ll review combination products integrated development and risk management considerations and essential performance requirements to support robust product development and lifecycle management
     
  • 9:50 Combination Product lifecycle management

    Michael Friedman

    Michael Friedman, Combination Product Lead, Amgen

  • Why is it important to incorporate risk management and design controls into the LCM of Combination products?
  • How to manage change through design controls
  • Use of platforms for optimization of development time and costs
  • Regulatory standards to consider
     
  • 10:30 Morning Coffee - Sponsored by Zeon

    11:00 Lifecycle Management of Combination Products - A Regulatory Perspective

    Jennifer  Hefele Wald

    Jennifer Hefele Wald, Director Global Regulatory Affairs Devices & Combination Products, Pfizer

  • Regulatory’s role in the product change assessments and DHF deliverables
  • Handling legacy combination products
  • What should be submitted for legacy and new combination products?
     
  • 11:40 Regulatory Perspective on Human Factors Requirements for Combination Products

    Heather  L. Guerin

    Heather L. Guerin, Associate Director, Regulatory Affairs - CMC, Janssen

  • Overview of Human Factors topics including platform approaches, training programs, and Instructions for Use
  • Importance of risk analysis and risk considerations in development of Human Factors Studies and communication of results
  • Best practices for incorporating Human Factors Studies results into regulatory filings
     
  • 12:20 FDA Postmarketing Safety Reporting for Combination Products Guidance

    Delma  L Broussard

    Delma L Broussard, Director, CSL Behring

    • Reporting requirements for combination products under PMSR final rule
    • Overview of report types based on constituent parts
    • Hypothetical examples of report types
     

    13:00 Networking Lunch

    14:00 Combination Products Evolving Trends

  • What are some of the significant challenges that people face in implementation of combination product regulations?
  • Is there anything uniquely challenging from a drug-led manufacturer versus a device-led manufacturer?
  • Can you comment on Post-Marketing Safety Reporting for Combination Products as it relates to risk management?
  • Susan Neadle

    Susan Neadle, Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson

    Jennifer  Hefele Wald

    Jennifer Hefele Wald, Director Global Regulatory Affairs Devices & Combination Products, Pfizer

    Delma  L Broussard

    Delma L Broussard, Director, CSL Behring

    Alie Jahangir

    Alie Jahangir, Senior Manager, Janssen Research Foundation

    Leonel Vanegas

    Leonel Vanegas, President / Principal , Resmedica Consulting LLC

    14:40 Latest Date of OXYCAPT Multilayer Plastic Vial & Syringe

    Shota Arakawa

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical Company, Inc

  • Comparison among OXYCAPT, COP and Glass
  • Excellent Oxygen & Ultraviolet Barrier
  • Oxidation and Aggregation Studies of Antibody
  • Development of Staked Needle Syringe
  • 15:20 Afternoon Tea - Sponsored by Zeon

    15:50 Design considerations for optimizing the user experience of prefilled syringes and injection devices

    Diane Doughty

    Diane Doughty, Senior Scientist, AstraZeneca

    • Device features of prefilled syringes and injection devices to support candidate device selection
    • Design considerations for minimizing pain upon injection
    • Case study of exploratory clinical study to evaluate injection parameters
     

    16:30 How Quality can help drug-device combination teams become agile in a changing regulatory landscape

    Leonel Vanegas

    Leonel Vanegas, President / Principal , Resmedica Consulting LLC

  • The role of quality and CMC during drug-device combination products evolution
  • Five steps towards becoming agile and flexible anticipating formulation changes before NDA/BLA filings
  • From pre-filled into a different presentation format after marketing approvals
  • Life-Cycle Management considerations (e.g. data you’ll need to demonstrate to the regulatory agencies)
  • 17:10 Chair’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alie Jahangir

    Alie Jahangir

    Senior Manager Combination Products and Emerging Technologies, Janssen
    Delma  L Broussard

    Delma L Broussard

    Director, CSL Behring
    Diane Doughty

    Diane Doughty

    Senior Scientist, AstraZeneca
    Heather  L. Guerin

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen
    Jennifer  Hefele Wald

    Jennifer Hefele Wald

    Director Global Regulatory Affairs Devices & Combination Products, Pfizer
    Juha Mattila

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Krystin Meidell

    Krystin Meidell

    Manager, Biogen Idec
    Larry Atupem

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Leonel Vanegas

    Leonel Vanegas

    President / Principal , Resmedica Consulting LLC
    Lin Li

    Lin Li

    Senior Consultant Engineer, Eli Lilly and Company Ltd
    Michael Friedman

    Michael Friedman

    Combination Product Lead, Amgen
    Michael Song

    Michael Song

    Sr. Manager, AstraZeneca
    Michael Zhou

    Michael Zhou

    Investigator, GSK Pharma
    Shota Arakawa

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical Company, Inc
    Susan Neadle

    Susan Neadle

    Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson
    Tanner Barnes

    Tanner Barnes

    Design Control Engineer II, Pfizer Inc.

    Alie Jahangir

    Senior Manager, Janssen Research Foundation
    Alie Jahangir

    Alie Jahangir

    Senior Manager Combination Products and Emerging Technologies, Janssen
    Alie Jahangir

    Delma L Broussard

    Director, CSL Behring
    Delma  L Broussard

    Diane Doughty

    Senior Scientist, AstraZeneca
    Diane Doughty

    Heather L. Guerin

    Associate Director, Regulatory Affairs - CMC, Janssen
    Heather  L. Guerin

    Jennifer Hefele Wald

    Director Global Regulatory Affairs Devices & Combination Products, Pfizer
    Jennifer  Hefele Wald

    Juha Mattila

    Director, Sterilisation Technologies, STERIS Corporation
    Juha Mattila

    Krystin Meidell

    Manager, Biogen Idec
    Krystin Meidell

    Larry Atupem

    Sr Business Development Specialist, Zeon Specialty Materials
    Larry Atupem

    Leonel Vanegas

    President / Principal , Resmedica Consulting LLC
    Leonel Vanegas

    Lin Li

    Senior Consultant Engineer, Eli Lilly and Company Ltd
    Lin Li

    Marco Egeth

    Senior Director, Core Human Factors, Inc
    Marco  Egeth

    Michael Friedman

    Combination Product Lead, Amgen
    Michael Friedman

    Michael Goehring

    Medical & Pharmaceutical Industry Manager, ZwickRoell
    Michael Goehring

    Michael Song

    Sr. Manager, AstraZeneca
    Michael Song

    Michael Song

    Sr. Manager, AstraZeneca
    Michael Song

    Michael Zhou

    Investigator, GSK Pharma
    Michael Zhou

    Patricia Anderson

    Senior Associate, Core Human Factors, Inc
    Patricia Anderson

    Shota Arakawa

    Researcher , Mitsubishi Gas Chemical Company, Inc
    Shota Arakawa

    Susan Neadle

    Sr. Director, Global Value Chain Quality Design, Head, J&J Combination Products CoP, Johnson & Johnson
    Susan Neadle

    Tanner Barnes

    Design Control Engineer II, Pfizer Inc.
    Tanner Barnes

    Tina Kiang

    Acting Director, Food and Drug Administration
    Tina Kiang

    Sponsors

    Exhibitors

    Official Media Partner

    Supporting Media Partners

    Workshops

    Pre-Filled Syringes East Coast Workshop Day
    Workshop

    Pre-Filled Syringes East Coast Workshop Day

    Sheraton Boston Hotel
    29th April 2020
    Boston, USA

    VENUE

    Sheraton Boston Hotel

    39 Dalton Street, Boston, MA, USA

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Past Attendees

    Download

    Workshop Day Programme

    Download

    Event Programme

    Download

    Past Presentation Shota Arakawa - MGC

    Download

    Past Presentation Patrick Gallagher - Schott

    Download

    Past Presentation Joyce Zhao - Takeda Pharmaceuticals

    Download

    Past Presentation Hemal Mehta - Janssen

    Download

    Past Presentation Ling Lu - Pfizer

    Download

    Past Presentation Carl Dabruzzi - West Pharmaceutical Services

    Download

    Past Presentation Brian Lewis - Eli, Lilly and Company

    Download

    Sponsors


    Mitsubishi Gas Chemical

    Sponsors
    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.


    STERIS

    Sponsors
    http://www.sterislifesciences.com

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.



    ZEON

    Sponsors
    http://www.zeonex.com

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

    Exhibitors


    Aptar Pharma

    Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    Credence MedSystems

    Exhibitors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Polyplastics

    Exhibitors
    https://topas.com

    Polyplastics is the leading maker of TOPAS COC (cyclic olefin copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes, vials and cartridges. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission.


    Weiss-Aug

    Exhibitors
    http://www.weiss-aug.com/

    The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies.

    With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery.



    ZwickRoell

    Exhibitors
    www.zwickroell.com

    ZwickRoell manufactures and supports a wide range of materials testing machines, systems and accessories for use in research, quality control, production environments and academia. Our extensive portfolio of testing machines and accessories cover almost every segment, from medical and pharmaceutical packaging to surgical instruments and orthopaedics and biomaterials.

    Media Partners


    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.


    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

    Media Partners


    Pharma network magazine

    Supporting Media Partners
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    Swiss Biotech Association

    Supporting Media Partners
    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.


    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Pharmacircle

    Supporting Media Partners
    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….


    Pharmalicensing

    Supporting Media Partners
    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.


    Mednous

    Supporting Media Partners
    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


    Labsave

    Supporting Media Partners
    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 Technology

    Supporting Media Partners
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Drug Discovery Today

    Supporting Media Partners
    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.


    Biosave

    Supporting Media Partners
    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.


    International Pharmaceutical Industry (IPI)

    Supporting Media Partners
    http://ipimediaworld.com/

    IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.


    Absave

    Supporting Media Partners
    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!


    Pharma Journalist

    Supporting Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    pharmaphorum

    Supporting Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    Farmavita

    Supporting Media Partners
    https://farmavitar.com

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


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    Technology Networks

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


    SciDoc Publishers

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    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    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.


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    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.

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    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

    GLOBAL CPD

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

    CPD Certificates

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

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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