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Building on last year's success, SMi's 2nd Annual Biosimilars & Biobetters USA returns to New Jersey in November! 

Biologic Therapeutics have revolutionised the treatment of many diseases and biosimilars are having a similar therapeutic efficacy with potentially lower costs to the health care system.


The approval of the first biosimilar in the US is expected to save the healthcare industry and patients $5.7 billion over the next decade. However, it is a complex landscape with complexity of manufacturing biologics making the development of biosimilars more challenging than the development of generics.


In addition to this, the upcoming patent cliffs facing manufacturers of blockbuster biologics are daunting – with over $60bn in branded biologic sales coming off patent in the next several years.


The biosimilars and biobetters industry is likely to become a lot more dynamic and strategic than we’ve seen with small molecule generics; there will begin to become a premium on flexibility and willingness to take chances in an ever-shifting competitive and regulatory environment.
 

The US biosimilars market is expected to reach $2 billion by 2018 and with the first biosimilar approved recently in America, this is an exciting time for the biosimilar field with approval in the US expected to increase during the next ten years. The regulatory landscape is evolving rapidly so it is important to understand the developments in the biosimilar guideline framework and the cohesion in legislation between the US and Europe.

The learning objectives in the US should be to fully understand the product lifecycle and all aspects of biosimilar research and development.

 

Watch this space…

 

Source - http://www.financierworldwide.com/competitive-strategies-in-life-sciences-biobetters-versus-biosimilars/#.VYBBtmVwbcs

 

This two-day conference will focus on debate, enhanced interaction and learning objectives focussed on the below;


Evaluating the regulatory landscape and pharmacovigilance of biosimilars
Assessing and challenging the BPCIAs dispute resolution process
Understanding and recognising the technical challenges in biosimilars
Discussing how to strategically plan and revolutionise biologics manufacturing
Reviewing the status on biosimilars - Clinical development and continued progress
Recognising commercialization strategies & improving market development
Developing further awareness on biobetters; are they the future?
Examining unexpected in results in Immunogenicity testing
 

 Job titles include but are not restricted to:
CSOs, CMOs, Vice Presidents, Presidents, Heads, Directors, Team Leaders, from the following roles:
• Biopharmaceuticals/ Biotherapeutics
• Follow on Biologics/Follow on Proteins/Biosimilars
• Biologics/Biotechnology/ Biogenerics
• Legal and Regulatory Affairs
• Intellectual Property
• Health Economics
• Pricing and Reimbursement
• Clinical Immunology
• Process Control and Analytical Technologies
• Analytical Characterisation
• Regulatory Compliance
• Pharmacovigilance
• Drug Safety & Risk Management
• Quality Affairs/ Quality Control
• New Product Development
• Process Science
• Portfolio Management
• Research & Development
• Business Development
• Business Operations
• Scientific Affairs
• Commercial Affairs and Strategic Planning
• Legislation and Policy Advice
 

 

AbbVie Ltd; Amgen Ltd; AriVan Research LLC; BD Biosciences; Ben Gurion University Of The Negev; Biopharm Insight; Bird & Bird; Boehringer Ingelheim Pharma GmbH & Co. KG; Bristows; Catalent Pharma Solutions; Dr Reddy’s Laboratories; Ecole Normale Supérieure de Cachan; Esteve SA; Euro Diagnostica AB; Europa Bioproducts Ltd; FirstWord; Formycon AG; Fresenius Kabi NV/SA; Frost & Sullivan; Genesun Biopharmaceuticals; Harvest Moon Pharmaceuticals; IMS Health UK; Interpharm Consultancy; Ludger Ltd; Lupin Limited; MedImmune Inc; Merck Serono; Merck Switzerland Limited; Mundipharma GmbH; Napp Pharmaceuticals; Norwegian Medicines Agency; Orion Corporation; PanGenerika; PSORIASENSE; SAI MedPartners; Sanofi Aventis; Schwegman Lundberg Woessner & Kluth; Takeda U K Ltd; Teva Pharmaceuticals; Thomson Reuters; Univercelles S.A.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Richard Dicicco

Richard Dicicco Chairman, Harvest Moon Pharmaceuticals

9:10 FDA's views on statistical analysis of quality attributes to establish biosimilarity

Ted Carver

Ted Carver Principal Consultant, PAREXEL

9:50 What can the US learn from European experiences?

Steinar Madsen

Steinar Madsen Medical Director, Norwegian Medicines Agency

  • Nine years of biosimilars in Europe – safety and efficacy
  • What are the regulatory differences between Europe and the US?
  • How important  is labelling and naming?
  • Uptake of biosimilars in clinical practice – lessons from Europe
  • 10:30 Morning Coffee

    11:00 SPOTLIGHT PRESENTATION: The first biosimilar approved by the FDA

    Jordanis Joy

    Jordanis Joy Biopharmaceutical Regulatory Affairs, Sandoz Inc

  • Looking at this case in detail, how did it progress and how will it develop
  • How did the FDA interpret their own guidelines
  • What can we learn from this first approval?
  • Looking ahead, what’s the future regarding more complex molecules?
  • 11:40 Panel Debate: Assessing the success criteria for commercialization for global biosimilars

    Magdalena Leszczyniecka

    Magdalena Leszczyniecka Founder and CEO, STC Biologics Inc

    Robin Chadwick

    Robin Chadwick Principal, Biotechnology, Schwegman Lundberg Woessner

    Rakesh Dixit

    Rakesh Dixit Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau Director of Portfolio Management & Strategy, Biosimilars, Merck Group

  • Gain insights as to what an optimal business model is for global commercialization of biosimilars: 1)  stand alone; 2) generic partnered with Big Pharma or Big Bio; 3)geographical or regional licensees; 4) distributors; 5) consortia; 6) contract development/ manufacturing for fingerprint-like similarity
  • Which model for which products?   1) first wave biosimilars 2) second wave biosimilars 3)  Third wave biosimilars and PD-1s
  • Geographical location – which model for which region?  1) Europe; 2) USA; 3) LATAM; 4) APAC; 5) Russia and CIS 

     

  • 12:20 Networking Lunch

    13:30 Perspectives on the evolving biosimilars landscape

    Michael Kleinrock

    Michael Kleinrock Research, Director, IMS Health Inc

  • The Global Biologic Market: understanding the place of biologics in medicine use around the world
  • Learning from the biosimilar experience: European experience can offer some insights into the U.S. future (and some confusion too)
  • Looking ahead to the next five years of biosimilar and biologic evolution
  • 14:10 Understanding the blurred lines between traditional innovators and generics

    Andrea Laslop

    Andrea Laslop Head of Scientific Office, Austrian Agency for Health and Food Safety

  • Scientific and quality considerations in demonstrating biosimilarity between the biosimilar and the reference product
  • Reviewing the need to show bioequivalence to the innovator drug based on pharmacokinetic parameters such as rate absorption and bioavailability
  • Understanding the complexity of biosimilar models from a clinical perspective
  • 14:50 Case Study: The First International Reference Standard

    Michael Tovey

    Michael Tovey INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan

  • Importance of reference Standards for the Development of biosimilars      
  • First WHO International Standard (IS) for the TNF-alpha sRII receptor-Fc fusion protein (Etanercept). 
  • First International Reference (IR) Preparation for anti-drug (anti-Eprex) antibodies
  • Other WHO IS & IRs for biosimilars currently in development
  • 15:30 Afternoon Tea

    16:00 Update: Can biobetters or biosuperiors meet the challenges of best in class molecules and cheaper biosimilars

    Rakesh Dixit

    Rakesh Dixit Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc

  • Making biobetters or biosuperiors successful and cost effective through advances in protein engineering and pioneering technologies - case studies of biosuperior vs. biosimilars
  • Evaluating the current innovations in improving existing biologics therapies in diseases with unmet medical needs
  • Identifying which products have significant potential for ‘biosuperior’ development
  • Developing biosuperior protein therapeutics that address sub-optimal, in-market characteristics of currently licensed biologics
  • Examining current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins 
  • 16:40 Impact of Glycosylation on the Biological Functions of Therapeutic Antibodies

    Raju Shantha

    Raju Shantha Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.

    17:20 The Great Debate - Interchangeability

    Richard Dicicco

    Richard Dicicco Chairman, Harvest Moon Pharmaceuticals

  • The determination of interchangeability: satisfying the FDA definition to achieve automatic substitution by the pharmacy without physician consultation
  • Will interchangeability minimize the uncertainty of biosimilar adoption?
  • How does INN naming affect automatic substitution?
  • What will the FDA interchangeability guideline look like?
  • Considerations in the design of switching studies #
  • How will interchangeability affect pricing and reimbursement?
  • Differentiation between the designation or practice of interchangeability in the US and EU
  • Which is more desirable for success: switching existing patients or interchangeability?
  • 18:00 Chairman’s Closing Remarks and Close of Day One

    Richard Dicicco

    Richard Dicicco Chairman, Harvest Moon Pharmaceuticals

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Richard Dicicco

    Richard Dicicco Chairman, Harvest Moon Pharmaceuticals

    9:10 The litigation landscape in Europe: where are we now?

    Dominic Adair

    Dominic Adair Partner, Patent Litigation, Bristows

  • The patent cliff and the patent hurdle – is it real?
  • When litigation begins, are the rules different?
  • Patent challenges in Europe – the EPO and the national courts
  • The future landscape – the Unified Patent Court
  • 9:50 Challenging the BPCIAs dispute resolution process

    Jim Nelson

    Jim Nelson Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner

  • Reviewing the use of IPR at the US PTO PTAB as an alternative to the Patent Dance of the BPCI Act
  • Claim term interpretation, what do these words mean?
  • Touching on the use of amendments
  • 10:10 Assessing the BPCI and FDA requirements for obtaining the right to sell a Biosimilar in the US

    Robin Chadwick

    Robin Chadwick Principal, Biotechnology, Schwegman Lundberg Woessner

  • Discussing semi-automated processes to identify and analyze US patents of interest to answer the question whether such patents should be listed on the biosimilar applicant’s proposed list of patents during the BPCI exchange
  • 10:30 Morning Coffee

    11:00 Case Study: Creating Biobetters with Improved Efficacy and Safety by Addressing Product Immunogenicity with Tolerogenic Nanoparticles

    Takashi Kei  Kishimoto

    Takashi Kei Kishimoto Chief Scientific Officer, Selecta Biosciences

  • The forthcoming flood of biosimilars will create a highly competitive, low margin marketplace. There will be a competitive advantage for biobetters that are differentiated based on their efficacy and safety profile
  • Anti-drug antibodies compromise the utility of many biologic drugs by neutralizing drug efficacy, modulating pharmacokinetics, and/or causing adverse events
  • We have developed tolerogenic synthetic vaccine particles (SVP) that are capable of inducing durable immune tolerance to biologic drugs. We will present case examples using tolerogenic SVP with adalimumab and pegylated uricase
  • 11:40 The fingerprinting approach - Expediting development of Biosimilars

    Magdalena Leszczyniecka

    Magdalena Leszczyniecka Founder and CEO, STC Biologics Inc

  • Because of the very high cost and length of time associated with biologics development, access to biosimilars at a lower cost with shorter development timelines would make these treatments more accessible to a greater number of patients
  • To realize cost and time savings from biosimilars, the current development model needs to change to follow the generic product development paradigm which requires only one bioequivalence trial
  • STC is currently working on fingerprinting approach to obtain approval on a biosimilar antibody product with only one clinial trial through the use of fingerprinting platform. This concept is described in a detailed publication by FDA’s Steve Kozlowski, indicating that a rigorous “fingerprint” like analytical and nonclinical pharmacological similarity could help lift many of the uncertainties/risks of the biosimilar product compared to the originator, which would decrease the burden of clinical trials conducted only to address any “residual uncertainty” not addressable by in vitro studies
  • 12:20 Networking Lunch

    13:30 What are the opportunities in America - Where will we be in 2018?

    Cliff Mintz

    Cliff Mintz Senior Writer/Correspondent, Life Science Leader

  • Strengthening long-term strategy to maximise return on investment and to benefit patients
  • How to seek partnership to develop and execute risk mitigation strategies
  • Forecasting market penetration – What are the factoring barriers to entry?
  • 14:10 Clinical & Regulatory Strategies Encompassing the Needs of East and West

    Gerry McGettigan

    Gerry McGettigan CEO & Regultory Expert; COO, Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)

  • What are the key features of a truly global development programme?
  • What obstacles should US / EU biosimilars companies be aware of in Asia and emerging markets
  • What changes do we need in development and regulatory requirements to facilitate truly global developments, and which stakeholders need to make these changes happen?
  • 14:50 Industry partnerships: Key Success Factors in Biosimilar Space

    Catherine Godrecka-Bareau

    Catherine Godrecka-Bareau Director of Portfolio Management & Strategy, Biosimilars, Merck Group

  •  Stand-alone situation: high R&D costs, unclear regulatory pathways, uncertain business model, incomplete portfolio
  • We will win together through innovative partnership models
  • Case study of the Airline industry: high fixed costs but low marginal costs
  • Translation to the biosimilar space
  • 15:30 Afternoon Tea

    16:00 Case Study: Where are we now and how will we develop?

    Carsten Brockmeyer

    Carsten Brockmeyer CEO, Formycon AG

  • Biosimilars will soon become number one products – but how to get there?
  • Lessons learned from the first European & US biosimilars
  • Creating a true global biosimilars strategy
  • Similarity exercise, clinical data, extrapolation
  • Monoclonal antibodies, a new milestone for the biosimilars market
  • Why biosimilars have been more successful than biobetters
  • Challenges and opportunities with third wave biosimilars
  • 16:40 Assessing emerging markets and enhancing strategies

    Sam Mukherjee

    Sam Mukherjee Associate Director Biosimilar Commercial Strategy and Portfolio Management, Dr. Reddy's Laboratories Inc.

  • How are emerging markets shifting in BRIC countries
  • Dealing with cost containment
  • How do emerging markets compare to the EU and US regulations
  • 17:20 Chairman’s Closing Remarks and Close of Day Two

    Richard Dicicco

    Richard Dicicco Chairman, Harvest Moon Pharmaceuticals

    +

    FEATURED SPEAKERS

    Andrea Laslop

    Andrea Laslop

    Head of Scientific Office, Austrian Agency for Health and Food Safety
    Carsten Brockmeyer

    Carsten Brockmeyer

    CEO, Formycon AG
    Cliff Mintz

    Cliff Mintz

    Senior Writer/Correspondent, Life Science Leader
    Dominic Adair

    Dominic Adair

    Partner, Patent Litigation, Bristows
    Gerry McGettigan

    Gerry McGettigan

    CEO & Regultory Expert; COO, Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)
    Jim Nelson

    Jim Nelson

    Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner
    Magdalena Leszczyniecka

    Magdalena Leszczyniecka

    Founder and CEO, STC Biologics Inc
    Michael Kleinrock

    Michael Kleinrock

    Research, Director, IMS Health Inc
    Michael Tovey

    Michael Tovey

    INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
    Raju Shantha

    Raju Shantha

    Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
    Richard Dicicco

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals
    Robin Chadwick

    Robin Chadwick

    Principal, Biotechnology, Schwegman Lundberg Woessner
    Steinar Madsen

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Takashi Kei  Kishimoto

    Takashi Kei Kishimoto

    Chief Scientific Officer, Selecta Biosciences

    Andrea Laslop

    Head of Scientific Office, Austrian Agency for Health and Food Safety
    Andrea Laslop

    Carsten Brockmeyer

    CEO, Formycon AG
    Carsten Brockmeyer

    Catherine Godrecka-Bareau

    Director of Portfolio Management & Strategy, Biosimilars, Merck Group
    Catherine Godrecka-Bareau

    Cliff Mintz

    Senior Writer/Correspondent, Life Science Leader
    Cliff Mintz

    Dominic Adair

    Partner, Patent Litigation, Bristows
    Dominic Adair

    Gerry McGettigan

    CEO & Regultory Expert; COO, Kinesys Consulting Ltd (UK); amp biosimilars AG (Germany)
    Gerry McGettigan

    Graeme Deuchar

    Product Development Expert, Kinesys Consulting Ltd
    Graeme Deuchar

    Jim Nelson

    Senior Principal and Owner, Adversarial Proceedings/Pharma & Biotech, Schwegman Lundberg Woessner
    Jim Nelson

    Jordanis Joy

    Biopharmaceutical Regulatory Affairs, Sandoz Inc
    Jordanis Joy

    Liz Yamashita

    VP, Regulatory & Clinical Affairs, Oncobiologics
    Liz Yamashita

    Magdalena Leszczyniecka

    Founder and CEO, STC Biologics Inc
    Magdalena Leszczyniecka

    Michael Kleinrock

    Research, Director, IMS Health Inc
    Michael Kleinrock

    Michael Tovey

    INSERM Director of Research, Laboratory of Biotechnology and Applied Pharmacology, Ecole Normale Supérieure de Cachan
    Michael Tovey

    Raju Shantha

    Scientific Director, Biologics Research, Janssen Pharmaceuticals, Inc.
    Raju Shantha

    Rakesh Dixit

    Vice President, R&D, Global Head, Biologics Safety Assessment, MedImmune Inc
    Rakesh Dixit

    Richard Dicicco

    Chairman, Harvest Moon Pharmaceuticals
    Richard Dicicco

    Robin Chadwick

    Principal, Biotechnology, Schwegman Lundberg Woessner
    Robin Chadwick

    Sam Mukherjee

    Associate Director Biosimilar Commercial Strategy and Portfolio Management, Dr. Reddy's Laboratories Inc.
    Sam Mukherjee

    Steinar Madsen

    Medical Director, Norwegian Medicines Agency
    Steinar Madsen

    Takashi Kei Kishimoto

    Chief Scientific Officer, Selecta Biosciences
    Takashi Kei  Kishimoto

    Ted Carver

    Principal Consultant, PAREXEL
    Ted Carver

    Sponsors and Exhibitors

    Platinum Media Partners

    Supporters

    ASSOCIATED EVENTS

    Development, Regulatory and Commercial Needs for Global Biosimilars
    Workshop

    Development, Regulatory and Commercial Needs for Global Biosimilars

    Renaissance Woodbridge Hotel
    18th November 2015
    Iselin, USA

    VENUE

    Renaissance Woodbridge Hotel

    515 US Highway 1 South, Iselin, New Jersey, USA

    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

    International Clinical and Regulatory Strategies to meet Global Commercial Needs Workshop Preview

    Download

    SMi Speaker Interview Series:Ted Carver, Principal Consultant from PAREXEL

    Download

    SMi Speaker Interview Series: Michael Kleinrock, Director Research Development, IMS Institute for Healthcare Informatics

    Download

    Preliminary List of Attending Organisations in 2015

    Download

    SMi Speaker Interview Series: Gerry McGettigan, CEO & Regulatory Expert from Kinesys Consulting Ltd

    Download

    SMi Speaker Interview Series: Schwegman Lundberg and Woessner P.A

    Download

    Sponsors


    Schwegman Lundberg & Woessner

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    Biosimilar News

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    BiosimilarNews.com is a leading international knowledge and information source about biosimilars. The site helps the industry professionals, clinicians and also the public to find timely and appropriate information about this specific area. Biosimilar News - We keep you up to date.


    Absave

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    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!


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    Antibodies Online

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    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.


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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.


    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.


    GenomeWeb

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    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.


    Global Information GII

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    Global Information Inc. (GII), established in 1983, is headquartered in Japan with overseas offices worldwide. GII partners with over 300 market research companies as well as more than 50 global conference organizers to provide comprehensive services to clients from all sectors and perform as an aggregator for research and conference information. GII clients enjoy real time and personalized services through our global presences. For more information, please visit: GII Research Services: http://www.giiresearch.com/about_en.shtml and GII Conferences: http://www.giiconference.com/


    Inderscience Publishers

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    http://www.inderscience.com

    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.


    International Journal of Behavioural and Healthcare Research

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    http://www.inderscience.com/ijbhr

    IJBHR addresses a broad range of original experimental and theoretical papers that deal with behavioural and healthcare concerns. It welcomes high-quality papers from scientists in academic and non-academic organisations as well as business and government worldwide. IJBHR is sponsored by the Business and Economics Society International and the Frontiers in Immunology Research Network.


    International Journal of Biotechnology

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    http://www.inderscience.com/ijbt

    IJBT provides an international forum and refereed authoritative source of information in the field of Biotechnology and Biotechnics, with emphasis on management and economics, as well as the political and social issues. It aims to disseminate knowledge, provide a learned reference in the field, and establish channels of communication between academic and research experts, policy makers and executives in industry, commerce and investment institutions.


    International Journal of Computational Biology and Drug Design

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    http://www.inderscience.com/ijcbdd

    IJCBDD, an International Society of Intelligent Biological Medicine official journal, bridges the gap between two very important, complementary disciplines, computational biology and drug design. Through advances in high-throughput genome sequencing and digital imaging technologies, biocomputing, drug design and medical research have unfolded new, predictive sciences such as genomics, proteomics, lipidomics, metabolomics, cytomics and pharmaconomics. These promote new computational, statistical and biomedical approaches to drug design/development, besides unleashing the potential of significantly more accurate, effective personalised diagnosis, therapeutics and patient care.


    International Journal of Environment and Health

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    IJEnvH is a fully-refereed scientific journal that provides an international forum for the exchange of information and the advancement of knowledge in the multidisciplinary field of environment and health. The aim of IJEnvH is to stimulate the discussion and communication among scientists, researchers and experts with different background and expertise, involved, at different levels, with the study of environment and health problems.


    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.


    Lab Bulletin

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    http://www.labbulletin.com

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


    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/


    Medical News Today

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    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.


    Pharma Marketing News

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    http://www.pharmamarketingnews.com" target="_blank" class="link" align="right"> http://www.pharmamarketingnews.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.


    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.


    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….


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


    pharmaphorum

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    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


    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.


    PMR

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    http://www.pmrcorporate.com

    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.


    Select Science

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    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.


    Sociable Pharma

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    http://www.sociablepharma.com

    Sociable Pharma offers a tailored range of research & analysis services to help pharmaceutical companies at all stages of the product lifecycle. We provide customized research & analysis solutions that address the evolving intelligence priorities of each marketed and pipeline product to deliver commercially-focused & highly relevant insight. Our Treatment Pulse business intelligence service helps pharmaceutical companies to understand physicians' perspectives on clinical practice, unmet needs and product differentiation, and continuous primary research analyzes the impact that industry issues will have on the treatment landscape and the implications for each product's competitive positioning.


    Swiss Biotech Association

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    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.


    Technology Networks

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

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

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

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    WHAT IS CPD?

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

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

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

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

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

    CPD AND PROFESSIONAL INSTITUTES

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

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

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

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

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

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

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

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

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

    GLOBAL CPD

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

    CPD Certificates

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

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, United Kingdom, Link to Map
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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