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ViBpharma
                                                                                                        Visit led rence Site
                                                                                                      – Pharm by Catalent
                                                                                                     your prin a solutions for
                                                                                                               ted co
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 2nd Annual                                                                                                  Free for .
                                                                                                      Pharma
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Pharma Packaging
                                                                                                          & Biotec turers
                                                                                                                    hs




and labeling usa
Tuesday May 18 & Wednesday May 19 2010, Philadelphia, usa

Critical developments in pharma packaging and labeling being
assessed by pharma leaders at the forefront of research

  hEaR FRoM inDusTRy WoRlD                                         KEy BEnEFiTs FoR aTTEnDinG:
  lEaDERs inCluDinG:
                                                                   • Hear 18 unique end user case studies from
  ■   Ron Guido                                                      the front line of pharma packaging and
  Vice President Global Brand Protection
  Johnson & Johnson                                                  labeling
  ■   James hagan                                                  • Discover the latest cost effective strategies for
  Vice President sustainability and Environment
  GlaxosMiThKlinE                                                    achieving your company’s sustainability goals
  ■   Gerald Miller                                                • Uncover critical developments in serialization
  Packaging Engineer – Global Product Protection
  Eli lilly anD CoMPany                                              and the implications for your company
  ■   William Bosley                                               • Defining how electronic labeling will benefit
  labeling specialist, Proprietary affairs labeling
   WaTson PhaRMaCEuTiCals inC
                                                                     you and reduce the labeling costs for your
  ■   arminda o. Montero                                             company
  Distribution Qa Program Manager strategic Quality initiatives
  aBBoTT laBoRaToRiEs
                                                                   • Analyze essential strategies that will help
  ■   Charles listigovers                                            you reduce waste & drive efficiency through
  senior Director Global Manufacturing Technology                    your packaging and labeling
  sanoFi PasTEuR
                                                                     activities
  ■   Daniel l. norwood, Ph.D.
  Distinguished Research Fellow
  BoEhRinGER inGElhEiM PhaRMaCEuTiCals, inC.

  ■   Tonja hampton                                                                             Catale
  Director Worldwide Product labeling                                                                   nt
  MERCK & Co                                                                                    if you would be d
                                                                                                        cou           elig
                                                                                                   drinks ld join them hted
                                                                                                           recep         for a
                                                                                                       end of tion at the
                                                                                                              day on
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  nETWoRK WiTh inDusTRy WoRlD lEaDERs inCluDinG:
  ■   GlaxosmithKline                  ■ Packaging science        ■ Gs1 healthcare us       ■ Genzyme Corporation
  ■   Johnson & Johnson                  Resources                ■ Watson                  ■ sanofi Pasteur
  ■   Merck & Co inc                   ■ Boehringer ingelheim       Pharmaceuticals inc     ■ abbott laboratories
  ■   Eli lilly and Company              Pharmaceuticals, inc.    ■ alpharma inc


Lead Sponsor:               Silver Sponsor:




Register online now at: www.arena-international.com/pharma/packagingusa
Program Day One                                                         Tuesday 18 May 2010

08:30 Registration and refreshments                                              11:30 sustainability Panel: strategies to meet your
                                                                                       organizations sustainability goals – uncovering
08:55 Chairman’s opening remarks:                                                      benchmarking opportunities
          Victor Dixon, Vice President and General Manager, Printed                     ●   Assessing the three top materials to endorse in your packaging
          Components, CaTalEnT                                                              strategy that will encourage sustainability efforts
                                                                                        ●   Evaluating the best labeling strategy that will guarantee
Critical insights on compliance with current FDa                                            sustainability improvements
regulation and international requirements to help you                                   ●   Identifying the most successful examples of sustainable sources
develop your strategy in the next 12 – 18 months                                            used in Pharma
                                                                                        ●   Deciding on realistic achievable sustainability goals and putting a
09:00 Keynote Presentation:                                                                 strategy in place to meet those
      Ensuring you are compliant in a world of constantly                               ●   Overcoming challenges in current technology; identifying when
      changing regulations – reviewing the regulatory                                       investment is required
                                                                                        ●   Determining which has the biggest environmental impact –
      landscape and what you can expect in the coming                                       process changes, reduction of material, or simplification of
      year                                                                                  packaging?
      ●   Analyzing the requirements of the Physician Labeling Rule and                     Mathew Thomas, Team leader – Packaging Development, Eli
          how they are being met                                                            lilly & CoMPany
      ●   Understanding the California Law and how the principles behind
          it will be implemented in the rest of the US
      ●   Determining the vision for electronic labeling and why it will be a
                                                                                 12:30 Lunch and networking
          successful policy in the long term

09:30 Keynote Presentation:
      Beyond Compliance: a business perspective on
      serialization to safeguard your supply chain
      ●   Assessing the technology investment required and optimizing
          spend on technology upgrade
      ●   Preparing your business for a successful implementation
      ●   Ensuring the supply chain is ready for serialization                     Packaging and Converting Intelligence delivers essential expert
          Ron Guido, Vice President Global Brand Protection, Johnson &             verdicts on all sectors within the packaging industry, including
          Johnson                                                                  food, beverage, cosmetic and personal care packaging sectors.
                                                                                   Within each section there is detailed focus on folding cartons
                                                                                   and cardboard, printing and labelling, flexible packaging, brand
10:00 Preparing for serialization and visibility within the                        protection, sustainability and many other key industry issues.
      us pharmaceutical supply chain
          Gain insights on the benefits of a fully implemented supply chain
      ●
          using GS1 Visibility Standards
                                                                                   Apply for your FREE subscription today
      ●   Utilize simulated supply chain processes to:                             visit, www.pci-mag.com
          - test exception processes to minimize implementation surprises
          - decrease the need for trading partner pilots                                             Europe’s Packing Magazine

          - generate GS1 standardized data to test your systems
          - test new concepts and data to discover additional benefits
      ●   Reducing implementation costs – helps to resolve majority of
          issues prior to implementation with trading partners
      ●   Provides confidence that an organization’s implementation is
                                                                                   Converting Today, Europe’s leading magazine for buyers and
          “trading partner ready”
                                                                                   specifiers of converting machinery, materials and services,
      ●   Provides confidence that a company’s trading partners are ready
                                                                                   provides in-depth features and all the latest industry news from
      ●   Take the lead in helping to develop a U.S. Pharmaceutical Supply
                                                                                   around the world. Published monthly, Converting Today keeps
          Chain Reference Model to support industry-wide implementation
                                                                                   thousands of key industry people up-to-date on developments in
          Bob Celeste, Director, Gs1 hEalThCaRE us
                                                                                   technology and trends, as well as the latest business news.

10:30 Morning refreshments and networking
                                                                                   Apply for your FREE subscription today
Developing strategies for sustainability in packaging                              visit, www.convertingtoday.co.uk
and labeling that can cut costs and enhance your
company’s green credentials
11:00 Defining sustainability and how you can measure it
      effectively to guarantee a winning strategy you can
      adopt when addressing the issue
      ●   Determining if renewable sources such as paper are the only
                                                                                    Established for over 20 years, Packaging Today provides Europe’s
          materials deemed sustainable
                                                                                    packaging professionals with an unrivalled mix of news, in-
      ●   Understanding how plastics and other materials can be made
                                                                                    depth features, opinion and analysis on key factors affecting
          environmentally friendly as renewable sources if treated correctly
                                                                                    their industry. With a pan-European circulation of 15,000 every
      ●   Evaluating the impact of electronic labeling on your sustainability
                                                                                    month, the magazine provides up-to-date information on the latest
          stance
                                                                                    business news, as well as developments in machinery, packaging
      ●   Assessing feasibility of switching from pvc to other polymers
                                                                                    materials and packs.
      ●   Evaluating the manufacturing process and the systematic
          approach that drives sustainability efforts before the end result is
          even achieved                                                             Apply for your FREE subscription today
      ●   How can pack standardization reduce the environmental footprint           visit, www.packagingtoday.co.uk
          of packaging?
          James hagan, Vice President sustainability and Environment,
          GlaxosMiThKlinE
Program Day One                                                           Tuesday 18 May 2010


Stream A:                                                                         Stream B:
innovations in packaging design, manufacture and                                  innovations in labeling – maximizing patient safety,
processing that increase efficiency reduce costs and                              ensuring regulatory compliance and limiting costs
minimize counterfeit risk
2:00 Determining which anti-counterfeiting technologies                            2:00 Examining Electronic labeling and industry/
to use in protecting your product                                                  Consumer impact
● Defining the problem                                                             ● History and current position of electronic labeling initiatives
● Additional information to consider                                               ● Reducing costs throughout with paperless package inserts – SKU,
● Special considerations for the Pharmaceutical Industry                             inventory, and life cycle management
● Possible Solutions                                                               ● Update labeling in-market and possibly avoid recalls
Gerald Miller, Packaging Engineer – Global Product Protection, Eli lilly           ● Reduce time to market requirements and eliminate distribution lag
anD CoMPany                                                                          time
                                                                                   ● Enhance ability to ensure labeling in market is always up-to-date
2:30 The Regulatory Environment for Extractables and                               ● Current opposition to paperless labeling
leachables – implications for packaging technology                                 ● Impact of paperless labeling and special considerations
● Understanding the current regulatory environment for extractables                William Bosley, labeling specialist, Proprietary affairs labeling,
  and leachables (US and EU)                                                       WaTson PhaRMaCEuTiCals inC
● Best practices for assessing extractables and leachables – case
  studies                                                                          2:30 Electronic Drug listing/structured Product
● Packaging and container closure system component selection                       labeling – Compliance Considerations
● Current industry initiatives and their implications for the future               ● eDRL/SPL Historical Situation, Perceived Need
Daniel l. norwood, Ph.D., Distinguished Research Fellow, BoEhRinGER                ● Listing requirements new to SPL
inGElhEiM PhaRMaCEuTiCals, inC.                                                    ● Project Scope of Implementation
                                                                                   ● Alternatives for Achieving Compliance
3:00 assessing and selecting anti tamper packaging                                 ● Cost Considerations
options                                                                            ● What’s next in Electronic Initiatives?
● Defining the problem                                                             Carol Garcia, Manager – Global labeling & Packaging, alPhaRMa inC
● Types of solutions available and possible FDA requirements
● Use of Physical/Chemical Identifiers (testing to ensure safety of use)           3:00 Minimizing packaging costs and reducing your
● Impact of implementing tamper evidence within manufacturing                      company’s Co2 footprint through the adoption of
● Evaluating relative cost of tamper evident options                               electronic labeling while ensuring the label content
amy l s Vangeloff, Global Manufacturing Product Protection Team                    is better than ever and easier for the pharmacists to
leader, Eli lilly anD CoMPany                                                      assimilate and notice any new changes
                                                                                   ● Removing the various labels that currently go into each packet will
3:30 Afternoon refreshments and networking                                           open the door for packets to be reduced in size saving resources and
                                                                                     will afford a company to transport more at a time
4:00 assessing how cost effective it is to remove certain                          ● Content label can be updated at a fraction of the time it would
materials from packaging while not compromising on                                   normally take because there will be no label printing time to adhere
the safety of the drugs                                                              to which can take up to 12 months normally
●   Reviewing how removing unit curtains can substantially reduce                  ● Labels can be more thorough and include additional information it is
    packaging costs                                                                  currently unfeasible to place on a label
●   How likely is it that the stock will be damaged by removing certain            ● Reduction in size of cold chain product packaging will save energy,
    packaging material?                                                              expense and the environment
●   Evaluating how removing materials from packaging can help you                  Theresa Brunone, assistant Director Global Regulatory operations,
    achieve sustainability goals                                                   GlaxosMiThKlinE
●   Determining how reducing packaging while cutting costs can be
    achieved without employing overtly expensive technologies
                                                                                   3:30 Afternoon refreshments and networking
                                                                                    4:00 Evaluating the best options in advertising and
4:30 innovative packaging techniques that ensure                                   promotional labelling
packages are both child resistant and elderly person                               ● Evaluating cost effective promotional options
friendly                                                                           ● Developing a successful strategy to maximise ROI
●   Achieving a balance between child resistance and elderly friendly              ● Assessing popular options and evaluating their effectiveness
    packaging                                                                      ● Analyzing new strategies – the pros and cons
●   Analyzing the cost of purchasing new technology that will streamline           Tammara lewis, Director advertising Promotion and labeling,
    the process                                                                    GEnzyME CoRPoRaTion
●   Defining the vision for how packaging is going to develop in this arena
●   Evaluating the best recent examples of innovative packaging options
                                                                                   4:30 understanding data mining – finding the most
    that meet both of these goals at once                                          up to date side effects and reflecting those on a label
                                                                                   when it is updated ensuring your product is fully
                                                                                   compliant
                                                                                   ●   Generating new streams for data mining
                                                                                   ●   Successfully capturing the latest trial data
                                                                                   ●   Re-labeling a drug accurately and ensuring changes are highlighted
                                                                                       for the patient
                                                                                   ●   Verifying testing outcomes to establish any changes to the side
                                                                                       effects are accurate and detailed in full

                                                                                   5:00     Chairman’s summation and close of day 1

                                                                                   5:10     Drinks reception hosted by Catalent
Program Day Two                                                     Wednesday 18 May 2010

08:30 Registration and refreshments                                              2:30   analyzing affordable anti-counterfeit technology
                                                                                        options that pharma can take advantage of
08:55 Chairman’s opening remarks                                                        ●   Identifying the drivers of counterfeiting in the US and strategies
                                                                                            to combat the main sources
                                                                                        ●   Evaluating available anti-counterfeiting strategies and assessing
09:00 speaker hosted Roundtables                                                            which one is the most suitable to adopt
       Interactive roundtable sessions offer a unique opportunity to                    ●   Understanding how anti-counterfeit technology will impact the
       come together with your peers to share best practice and develop                     pharmaceutical industry
       solutions to critical challenges facing the industry as a whole. Hosted          ●   Assessing serialization and track and trace technologies you can
       by industry experts and each focused on a single issue, roundtables                  implement
       are an exciting, interactive way to build your personal network and              ●   Determining the best preventative and authentication
       learn from the experience and expertise of others.                                   technologies
       Delegates can attend up to 3 round tables and may select from:
                                                                                 3:00   PanEl sEssion: evaluating strategies for the
       RounDTaBlE 1: assessing anti-counterfeit                                         successful implementation of E-Pedigree
                                                                                            Mapping the vision for E-pedigree in the US over the next 2-3
       technology options and tamper-evident techniques –                               ●
                                                                                            years
       reliability and affordability                                                    ●   Identifying the role E-pedigree will play in combating counterfeit
       David howard, Director of Global Product Protection, Johnson &                       medication in the US
       Johnson                                                                          ●   Assessing the cost of E-pedigree implementation on a large to
                                                                                            medium scale Pharma company
       RounDTaBlE 2: Establishing operational advantages
                                                                                        ●   Establishing the main challenges involved in the implementation
       of endorsing electronic labeling and what is                                         of E-pedigree & strategies to overcome these
       necessary for it to work smoothly                                                    Michael Ventura, serialization Business lead, GlaxosmithKline
                                                                                            Charles listigovers, senior Director, Global Manufacturing
       RounDTaBlE 3: Keeping abreast with regulatory /                                      Technology, sanoFi PasTEuR
       legislation changes that need to be implemented on
       existing labeling and developing efficient methods                        3:30   Afternoon refreshments and networking
       to help you achieve them
       Tonja hampton, Director Worldwide Product labeling, MERCK & Co            Evaluating cold chain strategies for packaging and
11:00 Morning refreshments and networking                                        labeling that ensure the integrity of the cold chain
                                                                                 from manufacturer to end user
11:30 RounDTaBlE 4: Defining technology options that will                        4:00   Cold Chain packaging – addressing Real-World
      help you gain sustainability credentials while saving                             Distribution Challenges and Regulatory Expectations
      you costs overall                                                                 ●   Design Considerations – understanding product requirements,
                                                                                            ambient temperature profiles, shipping process
                                                                                        ●   Qualification Guidance – from design qualification to operational
Cost effective strategies to guard against                                                  qualification to performance qualification
counterfeit medicines, to protect your brand and                                        ●   Post-Qualification Performance – meeting product requirements
safeguard the patient                                                                       and regulatory expectations
                                                                                        ●   What’s Next? – controlled-room temperature products (product
12:30 Determining the best anti-counterfeit supply chain                                    stability, packaging, transportation)
      options you can implement to ensure medicine                                          arminda o. Montero, Distribution Qa Program Manager strategic
      package traceability                                                                  Quality initiatives, aBBoTT laBoRaToRiEs
       ●   A deep dive into how RFID tagging can help guard against
           counterfeit medication                                                4:30   Distribution of Products at liquid nitrogen
       ●   Evaluating the advantages of using Data Matrix codes on                      Temperatures – Challenges and solutions
           packages                                                                     ●   What shipping and storage containers are available?
       ●   Fighting drug diversion by maximizing supply chain visibility                ●   What are the current distribution logistics? Who is able and
       ●   Determining the most common failures that allow counterfeit                      willing to transport these products?
           medication to enter the supply chain and how you can best                    ●   What is required by hospitals, clinics, pharmacies and other
           addressed them                                                                   patient administration sites to receive and store these products?
1:00   Defining anti-counterfeiting strategies and                                      ●   What unique risks and costs do very low temperature products
       technologies                                                                         present?
       ●   Evaluation of the global supply chain                                            Dr Edward J. smith Ph.D., Principle Consultant, PaCKaGinG
       ●   Assessment of strategic elements                                                 sCiEnCE REsouRCEs
       ●   Explore technologies for a successful program
       ●   Serialization – comparing RFID and 2D bar codes                       5:00   Defining the labeling challenges surrounding cold
           James Pierantozzi, Consultant – Pharmaceutical Packaging,
                                                                                        chain products and how to overcome those
           recently retired from WyETh
                                                                                        ●   Developing a label that will endure temperature extremes intact
                                                                                        ●   Generating a label that will ensure the product is globally
1:30   Lunch and networking                                                                 recognized as very cold chain and thus demand priority when
                                                                                            being dealt with during shipping and transportation
                                                                                        ●   Minimizing the size of labeling inserts for very cold chain
                                                                                            products
                                                                                        ●   Effective tracking and tracing of very cold chain products

                                                                                 5:30   Chairman’s summation

                                                                                 5:40   Close of conference
POST-CONFERENCE WORKSHOP                                                   lead sponsor:
The post-conference Catalent site visit                                    CaTalEnT PhaRMa soluTions Solutions is

– Pharma solutions for your printed                                        the only global, full service pharmaceutical
                                                                           printed component supplier with an integrated
component challenges                                                       network of packaging operations. Catalent has multiple facilities in the
                                                                           US, Puerto Rico and Europe dedicated to the pharmaceutical healthcare
Thursday May 20, 2010
                                                                           industry. With unique printing capabilities, Catalent can satisfy
Led by: Victor Dixon, Vice President and General                           customer demand for folding cartons, blister cards, inserts/outserts,
Manager, Printed Components, Catalent                                      pharmaceutical labels, clinical trial case reports, and pharmaceutical
                                                                           patient information materials printing. These extensive capabilities
about the workshop:                                                        enable manufacturers to simplify their supply chains by using a single
                                                                           source for all components, maintain consistent quality across their
This on-site interactive workshop at Catalent’s printed component site     products, and leverage economies of scale offered by multiple sites and
in New Jersey, just across the river from Philadelphia, will demonstrate   capabilities.
the solutions and technologies necessary to ensure that your cartons,
                                                                           Catalent is a true turnkey provider with an integrated network for
labels and inserts/outserts are of the highest quality and are
                                                                           pharmaceutical printed components and packaging services, and is well
produced in the most efficient manner. You will also be given a live
                                                                           positioned to serve you, wherever you do business. www.catalent.com
demonstration of their e-magineering services and capabilities and
other technology solutions
                                                                           silver sponsor:
                                                                           PRisyM iD works with many of the world’s
  Workshop agenda:                                                         largest pharmaceutical and medical device
                                                                           companies, providing validated life sciences labelling management
  09:30 Bus Transfer to Catalent’s facilities                              solutions for over 20 years. Specialising in FDA 21 CFR part 11 compliance,
                                                                           PRISYM ID's Medica product is the world's only GMP based, purpose
  10:00 Welcome to delegates by Victor Dixon                               designed labelling management software for FDA regulated environments.
  10:15 Guided tour of Catalent’s printed component                        Compliant Labeling Solutions www.prisymls.com
        site

  11:00 Presentation of core technologies and
                                                                           Media Partners:
                                                                           PaCKaGinG GaTEWay PaCKaGinG
        solutions                                                          executives from around the world use
                                                                           Packaging Gateway to keep abreast of the latest industry developments
  12:00 Question and answer session                                        and to make informed purchasing decisions throughout the entire supply
                                                                           chain. www.packaging-gateway.com
  12:30 Lunch reception                                                    PaCKaGinG & ConVERTinG inTElliGEnCE
                                                                           Packaging and Converting Intelligence delivers
  13:45 End of site visit and bus transfer back to the                     essential expert verdicts on all sectors within the
        hotel                                                              packaging industry, including food, beverage, pharmaceutical, cosmetic
                                                                           and personal care packaging sectors. Within each section there is
                                                                           detailed focus on folding cartons and cardboard, printing and labelling,
                                                                           flexible packaging, brand protection, sustainability and many other key
                                                                           industry issues. It has a controlled and audited readership of 11,000
                                                                           industry professionals, chosen for their high levels of purchasing and
                                                                           decision making power. www.pci-mag.com

                                                                           PhaRMaCEuTiCal TEChnoloGy is used daily
                                                                           as a means of creating partnerships and as a
                                                                           point of reference by professionals within the
                                                                           pharmaceutical industry. This comprehensive resource supplies the latest
                                                                           news releases, detailed information on industry projects, white papers,
                                                                           event information and a thorough breakdown of products and services.
                                                                           www.pharmaceutical-technology.com

                                                                           WoRlD PhaRMaCEuTiCal FRonTiERs The
                                                                           pharmaceutical industry is changing fast. There     World Pharmaceutical Frontiers   www.worldpharmaceuticals.net



  Who should attend                                                        are more regulations, technologies, faster product launches and shorter
  Directors, VP’s, Managers, and Leaders of                                product life cycles than ever before. World Pharmaceuticals frontiers
                                                                           is, and will continue to be, at the forefront of these changes, so visit us
  ●   Packaging,                                                           at www.worldpharmaceuticals.net and stay up to date with all latest
  ●   Labeling,                                                            developments.
  ●   Regulatory Affairs
  ●   Engineers                                                            ThE BusinEss REViEW websites are your number one
  ●   Specialists for Packaging and Labeling                               stop for all the latest news, comment and industry
                                                                           information. Each Business Review website offers
  ●   Serialization Manager
                                                                           content that is produced by a dedicated team of journalists and global
  ●   Technology specialists                                               industry experts.
                                                                              In addition to the free content made available on the sites an
                                                                           intelligence store will provide you with premium market analysis reports
                                                                           from the leading global suppliers of market research and industry
  Do you wish to exhibit your products and services                        analysis.
  at this exclusive event?                                                    Pharmaceutical Business Review is the world's leading pharma
  If you want to be part of this leading industry event,                   website, being used by over 100,000 visitors every month.
                                                                              For further information contact jsharp@industryreview.com
  please contact Rizwan Qayum in our sponsorship team.
  Email: rizwanqayum@arena-international.com or call:                      MEDiCal ETRaCK is the new, interactive
                                                                           desktop tool designed for executives &
   +44 (0)20 7753 4259                                                     analysts active in or supplying services to the medical equipment
                                                                           industry. www.medicaletrack.com
Booking Form
     2nd Annual Pharma Packaging and Labelling USA, Tuesday May 18 & Wednesday May 19 2010, Philadelphia, USA

                                                                Before              Before                Before                After                     Four Easy Ways To Book:
 Yes, I would like to register for the event:                   19 February         16 March              16 April              16 April                  ■ Register online at
 Representatives from biotech and pharma companies                                                                                                        www.arena-international.com/pharma/packagingusa
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 interactive CD-ROM
                                                                                                                                                          ■ Fax +44 (0)20 7915 9773
 I would like to attend the two day conference +
                                                                   $999                 $1099                 $1249                $1499
 Catalent’s Site Visit
 I would like to attend the two day conference +
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 interactive CD ROM (Saving $70)
                                                                                                                                                          Venue Details
 I would like to attend the two day conference only                $999                 $1099                 $1249                $1499
                                                                                                                                                          The two day conference will take place on Tuesday May 18
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                                                                                                                                                          located in Philadelphia, USA. For further information contact
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Pharma packaging & Labeling USA Conference

  • 1. Post Con fe ViBpharma Visit led rence Site – Pharm by Catalent your prin a solutions for ted co challeng mponent es 2nd Annual Free for . Pharma nufac Pharma Packaging & Biotec turers hs and labeling usa Tuesday May 18 & Wednesday May 19 2010, Philadelphia, usa Critical developments in pharma packaging and labeling being assessed by pharma leaders at the forefront of research hEaR FRoM inDusTRy WoRlD KEy BEnEFiTs FoR aTTEnDinG: lEaDERs inCluDinG: • Hear 18 unique end user case studies from ■ Ron Guido the front line of pharma packaging and Vice President Global Brand Protection Johnson & Johnson labeling ■ James hagan • Discover the latest cost effective strategies for Vice President sustainability and Environment GlaxosMiThKlinE achieving your company’s sustainability goals ■ Gerald Miller • Uncover critical developments in serialization Packaging Engineer – Global Product Protection Eli lilly anD CoMPany and the implications for your company ■ William Bosley • Defining how electronic labeling will benefit labeling specialist, Proprietary affairs labeling WaTson PhaRMaCEuTiCals inC you and reduce the labeling costs for your ■ arminda o. Montero company Distribution Qa Program Manager strategic Quality initiatives aBBoTT laBoRaToRiEs • Analyze essential strategies that will help ■ Charles listigovers you reduce waste & drive efficiency through senior Director Global Manufacturing Technology your packaging and labeling sanoFi PasTEuR activities ■ Daniel l. norwood, Ph.D. Distinguished Research Fellow BoEhRinGER inGElhEiM PhaRMaCEuTiCals, inC. ■ Tonja hampton Catale Director Worldwide Product labeling nt MERCK & Co if you would be d cou elig drinks ld join them hted recep for a end of tion at the day on e nETWoRK WiTh inDusTRy WoRlD lEaDERs inCluDinG: ■ GlaxosmithKline ■ Packaging science ■ Gs1 healthcare us ■ Genzyme Corporation ■ Johnson & Johnson Resources ■ Watson ■ sanofi Pasteur ■ Merck & Co inc ■ Boehringer ingelheim Pharmaceuticals inc ■ abbott laboratories ■ Eli lilly and Company Pharmaceuticals, inc. ■ alpharma inc Lead Sponsor: Silver Sponsor: Register online now at: www.arena-international.com/pharma/packagingusa
  • 2. Program Day One Tuesday 18 May 2010 08:30 Registration and refreshments 11:30 sustainability Panel: strategies to meet your organizations sustainability goals – uncovering 08:55 Chairman’s opening remarks: benchmarking opportunities Victor Dixon, Vice President and General Manager, Printed ● Assessing the three top materials to endorse in your packaging Components, CaTalEnT strategy that will encourage sustainability efforts ● Evaluating the best labeling strategy that will guarantee Critical insights on compliance with current FDa sustainability improvements regulation and international requirements to help you ● Identifying the most successful examples of sustainable sources develop your strategy in the next 12 – 18 months used in Pharma ● Deciding on realistic achievable sustainability goals and putting a 09:00 Keynote Presentation: strategy in place to meet those Ensuring you are compliant in a world of constantly ● Overcoming challenges in current technology; identifying when changing regulations – reviewing the regulatory investment is required ● Determining which has the biggest environmental impact – landscape and what you can expect in the coming process changes, reduction of material, or simplification of year packaging? ● Analyzing the requirements of the Physician Labeling Rule and Mathew Thomas, Team leader – Packaging Development, Eli how they are being met lilly & CoMPany ● Understanding the California Law and how the principles behind it will be implemented in the rest of the US ● Determining the vision for electronic labeling and why it will be a 12:30 Lunch and networking successful policy in the long term 09:30 Keynote Presentation: Beyond Compliance: a business perspective on serialization to safeguard your supply chain ● Assessing the technology investment required and optimizing spend on technology upgrade ● Preparing your business for a successful implementation ● Ensuring the supply chain is ready for serialization Packaging and Converting Intelligence delivers essential expert Ron Guido, Vice President Global Brand Protection, Johnson & verdicts on all sectors within the packaging industry, including Johnson food, beverage, cosmetic and personal care packaging sectors. Within each section there is detailed focus on folding cartons and cardboard, printing and labelling, flexible packaging, brand 10:00 Preparing for serialization and visibility within the protection, sustainability and many other key industry issues. us pharmaceutical supply chain Gain insights on the benefits of a fully implemented supply chain ● using GS1 Visibility Standards Apply for your FREE subscription today ● Utilize simulated supply chain processes to: visit, www.pci-mag.com - test exception processes to minimize implementation surprises - decrease the need for trading partner pilots Europe’s Packing Magazine - generate GS1 standardized data to test your systems - test new concepts and data to discover additional benefits ● Reducing implementation costs – helps to resolve majority of issues prior to implementation with trading partners ● Provides confidence that an organization’s implementation is Converting Today, Europe’s leading magazine for buyers and “trading partner ready” specifiers of converting machinery, materials and services, ● Provides confidence that a company’s trading partners are ready provides in-depth features and all the latest industry news from ● Take the lead in helping to develop a U.S. Pharmaceutical Supply around the world. Published monthly, Converting Today keeps Chain Reference Model to support industry-wide implementation thousands of key industry people up-to-date on developments in Bob Celeste, Director, Gs1 hEalThCaRE us technology and trends, as well as the latest business news. 10:30 Morning refreshments and networking Apply for your FREE subscription today Developing strategies for sustainability in packaging visit, www.convertingtoday.co.uk and labeling that can cut costs and enhance your company’s green credentials 11:00 Defining sustainability and how you can measure it effectively to guarantee a winning strategy you can adopt when addressing the issue ● Determining if renewable sources such as paper are the only Established for over 20 years, Packaging Today provides Europe’s materials deemed sustainable packaging professionals with an unrivalled mix of news, in- ● Understanding how plastics and other materials can be made depth features, opinion and analysis on key factors affecting environmentally friendly as renewable sources if treated correctly their industry. With a pan-European circulation of 15,000 every ● Evaluating the impact of electronic labeling on your sustainability month, the magazine provides up-to-date information on the latest stance business news, as well as developments in machinery, packaging ● Assessing feasibility of switching from pvc to other polymers materials and packs. ● Evaluating the manufacturing process and the systematic approach that drives sustainability efforts before the end result is even achieved Apply for your FREE subscription today ● How can pack standardization reduce the environmental footprint visit, www.packagingtoday.co.uk of packaging? James hagan, Vice President sustainability and Environment, GlaxosMiThKlinE
  • 3. Program Day One Tuesday 18 May 2010 Stream A: Stream B: innovations in packaging design, manufacture and innovations in labeling – maximizing patient safety, processing that increase efficiency reduce costs and ensuring regulatory compliance and limiting costs minimize counterfeit risk 2:00 Determining which anti-counterfeiting technologies 2:00 Examining Electronic labeling and industry/ to use in protecting your product Consumer impact ● Defining the problem ● History and current position of electronic labeling initiatives ● Additional information to consider ● Reducing costs throughout with paperless package inserts – SKU, ● Special considerations for the Pharmaceutical Industry inventory, and life cycle management ● Possible Solutions ● Update labeling in-market and possibly avoid recalls Gerald Miller, Packaging Engineer – Global Product Protection, Eli lilly ● Reduce time to market requirements and eliminate distribution lag anD CoMPany time ● Enhance ability to ensure labeling in market is always up-to-date 2:30 The Regulatory Environment for Extractables and ● Current opposition to paperless labeling leachables – implications for packaging technology ● Impact of paperless labeling and special considerations ● Understanding the current regulatory environment for extractables William Bosley, labeling specialist, Proprietary affairs labeling, and leachables (US and EU) WaTson PhaRMaCEuTiCals inC ● Best practices for assessing extractables and leachables – case studies 2:30 Electronic Drug listing/structured Product ● Packaging and container closure system component selection labeling – Compliance Considerations ● Current industry initiatives and their implications for the future ● eDRL/SPL Historical Situation, Perceived Need Daniel l. norwood, Ph.D., Distinguished Research Fellow, BoEhRinGER ● Listing requirements new to SPL inGElhEiM PhaRMaCEuTiCals, inC. ● Project Scope of Implementation ● Alternatives for Achieving Compliance 3:00 assessing and selecting anti tamper packaging ● Cost Considerations options ● What’s next in Electronic Initiatives? ● Defining the problem Carol Garcia, Manager – Global labeling & Packaging, alPhaRMa inC ● Types of solutions available and possible FDA requirements ● Use of Physical/Chemical Identifiers (testing to ensure safety of use) 3:00 Minimizing packaging costs and reducing your ● Impact of implementing tamper evidence within manufacturing company’s Co2 footprint through the adoption of ● Evaluating relative cost of tamper evident options electronic labeling while ensuring the label content amy l s Vangeloff, Global Manufacturing Product Protection Team is better than ever and easier for the pharmacists to leader, Eli lilly anD CoMPany assimilate and notice any new changes ● Removing the various labels that currently go into each packet will 3:30 Afternoon refreshments and networking open the door for packets to be reduced in size saving resources and will afford a company to transport more at a time 4:00 assessing how cost effective it is to remove certain ● Content label can be updated at a fraction of the time it would materials from packaging while not compromising on normally take because there will be no label printing time to adhere the safety of the drugs to which can take up to 12 months normally ● Reviewing how removing unit curtains can substantially reduce ● Labels can be more thorough and include additional information it is packaging costs currently unfeasible to place on a label ● How likely is it that the stock will be damaged by removing certain ● Reduction in size of cold chain product packaging will save energy, packaging material? expense and the environment ● Evaluating how removing materials from packaging can help you Theresa Brunone, assistant Director Global Regulatory operations, achieve sustainability goals GlaxosMiThKlinE ● Determining how reducing packaging while cutting costs can be achieved without employing overtly expensive technologies 3:30 Afternoon refreshments and networking 4:00 Evaluating the best options in advertising and 4:30 innovative packaging techniques that ensure promotional labelling packages are both child resistant and elderly person ● Evaluating cost effective promotional options friendly ● Developing a successful strategy to maximise ROI ● Achieving a balance between child resistance and elderly friendly ● Assessing popular options and evaluating their effectiveness packaging ● Analyzing new strategies – the pros and cons ● Analyzing the cost of purchasing new technology that will streamline Tammara lewis, Director advertising Promotion and labeling, the process GEnzyME CoRPoRaTion ● Defining the vision for how packaging is going to develop in this arena ● Evaluating the best recent examples of innovative packaging options 4:30 understanding data mining – finding the most that meet both of these goals at once up to date side effects and reflecting those on a label when it is updated ensuring your product is fully compliant ● Generating new streams for data mining ● Successfully capturing the latest trial data ● Re-labeling a drug accurately and ensuring changes are highlighted for the patient ● Verifying testing outcomes to establish any changes to the side effects are accurate and detailed in full 5:00 Chairman’s summation and close of day 1 5:10 Drinks reception hosted by Catalent
  • 4. Program Day Two Wednesday 18 May 2010 08:30 Registration and refreshments 2:30 analyzing affordable anti-counterfeit technology options that pharma can take advantage of 08:55 Chairman’s opening remarks ● Identifying the drivers of counterfeiting in the US and strategies to combat the main sources ● Evaluating available anti-counterfeiting strategies and assessing 09:00 speaker hosted Roundtables which one is the most suitable to adopt Interactive roundtable sessions offer a unique opportunity to ● Understanding how anti-counterfeit technology will impact the come together with your peers to share best practice and develop pharmaceutical industry solutions to critical challenges facing the industry as a whole. Hosted ● Assessing serialization and track and trace technologies you can by industry experts and each focused on a single issue, roundtables implement are an exciting, interactive way to build your personal network and ● Determining the best preventative and authentication learn from the experience and expertise of others. technologies Delegates can attend up to 3 round tables and may select from: 3:00 PanEl sEssion: evaluating strategies for the RounDTaBlE 1: assessing anti-counterfeit successful implementation of E-Pedigree Mapping the vision for E-pedigree in the US over the next 2-3 technology options and tamper-evident techniques – ● years reliability and affordability ● Identifying the role E-pedigree will play in combating counterfeit David howard, Director of Global Product Protection, Johnson & medication in the US Johnson ● Assessing the cost of E-pedigree implementation on a large to medium scale Pharma company RounDTaBlE 2: Establishing operational advantages ● Establishing the main challenges involved in the implementation of endorsing electronic labeling and what is of E-pedigree & strategies to overcome these necessary for it to work smoothly Michael Ventura, serialization Business lead, GlaxosmithKline Charles listigovers, senior Director, Global Manufacturing RounDTaBlE 3: Keeping abreast with regulatory / Technology, sanoFi PasTEuR legislation changes that need to be implemented on existing labeling and developing efficient methods 3:30 Afternoon refreshments and networking to help you achieve them Tonja hampton, Director Worldwide Product labeling, MERCK & Co Evaluating cold chain strategies for packaging and 11:00 Morning refreshments and networking labeling that ensure the integrity of the cold chain from manufacturer to end user 11:30 RounDTaBlE 4: Defining technology options that will 4:00 Cold Chain packaging – addressing Real-World help you gain sustainability credentials while saving Distribution Challenges and Regulatory Expectations you costs overall ● Design Considerations – understanding product requirements, ambient temperature profiles, shipping process ● Qualification Guidance – from design qualification to operational Cost effective strategies to guard against qualification to performance qualification counterfeit medicines, to protect your brand and ● Post-Qualification Performance – meeting product requirements safeguard the patient and regulatory expectations ● What’s Next? – controlled-room temperature products (product 12:30 Determining the best anti-counterfeit supply chain stability, packaging, transportation) options you can implement to ensure medicine arminda o. Montero, Distribution Qa Program Manager strategic package traceability Quality initiatives, aBBoTT laBoRaToRiEs ● A deep dive into how RFID tagging can help guard against counterfeit medication 4:30 Distribution of Products at liquid nitrogen ● Evaluating the advantages of using Data Matrix codes on Temperatures – Challenges and solutions packages ● What shipping and storage containers are available? ● Fighting drug diversion by maximizing supply chain visibility ● What are the current distribution logistics? Who is able and ● Determining the most common failures that allow counterfeit willing to transport these products? medication to enter the supply chain and how you can best ● What is required by hospitals, clinics, pharmacies and other addressed them patient administration sites to receive and store these products? 1:00 Defining anti-counterfeiting strategies and ● What unique risks and costs do very low temperature products technologies present? ● Evaluation of the global supply chain Dr Edward J. smith Ph.D., Principle Consultant, PaCKaGinG ● Assessment of strategic elements sCiEnCE REsouRCEs ● Explore technologies for a successful program ● Serialization – comparing RFID and 2D bar codes 5:00 Defining the labeling challenges surrounding cold James Pierantozzi, Consultant – Pharmaceutical Packaging, chain products and how to overcome those recently retired from WyETh ● Developing a label that will endure temperature extremes intact ● Generating a label that will ensure the product is globally 1:30 Lunch and networking recognized as very cold chain and thus demand priority when being dealt with during shipping and transportation ● Minimizing the size of labeling inserts for very cold chain products ● Effective tracking and tracing of very cold chain products 5:30 Chairman’s summation 5:40 Close of conference
  • 5. POST-CONFERENCE WORKSHOP lead sponsor: The post-conference Catalent site visit CaTalEnT PhaRMa soluTions Solutions is – Pharma solutions for your printed the only global, full service pharmaceutical printed component supplier with an integrated component challenges network of packaging operations. Catalent has multiple facilities in the US, Puerto Rico and Europe dedicated to the pharmaceutical healthcare Thursday May 20, 2010 industry. With unique printing capabilities, Catalent can satisfy Led by: Victor Dixon, Vice President and General customer demand for folding cartons, blister cards, inserts/outserts, Manager, Printed Components, Catalent pharmaceutical labels, clinical trial case reports, and pharmaceutical patient information materials printing. These extensive capabilities about the workshop: enable manufacturers to simplify their supply chains by using a single source for all components, maintain consistent quality across their This on-site interactive workshop at Catalent’s printed component site products, and leverage economies of scale offered by multiple sites and in New Jersey, just across the river from Philadelphia, will demonstrate capabilities. the solutions and technologies necessary to ensure that your cartons, Catalent is a true turnkey provider with an integrated network for labels and inserts/outserts are of the highest quality and are pharmaceutical printed components and packaging services, and is well produced in the most efficient manner. You will also be given a live positioned to serve you, wherever you do business. www.catalent.com demonstration of their e-magineering services and capabilities and other technology solutions silver sponsor: PRisyM iD works with many of the world’s Workshop agenda: largest pharmaceutical and medical device companies, providing validated life sciences labelling management 09:30 Bus Transfer to Catalent’s facilities solutions for over 20 years. Specialising in FDA 21 CFR part 11 compliance, PRISYM ID's Medica product is the world's only GMP based, purpose 10:00 Welcome to delegates by Victor Dixon designed labelling management software for FDA regulated environments. 10:15 Guided tour of Catalent’s printed component Compliant Labeling Solutions www.prisymls.com site 11:00 Presentation of core technologies and Media Partners: PaCKaGinG GaTEWay PaCKaGinG solutions executives from around the world use Packaging Gateway to keep abreast of the latest industry developments 12:00 Question and answer session and to make informed purchasing decisions throughout the entire supply chain. www.packaging-gateway.com 12:30 Lunch reception PaCKaGinG & ConVERTinG inTElliGEnCE Packaging and Converting Intelligence delivers 13:45 End of site visit and bus transfer back to the essential expert verdicts on all sectors within the hotel packaging industry, including food, beverage, pharmaceutical, cosmetic and personal care packaging sectors. Within each section there is detailed focus on folding cartons and cardboard, printing and labelling, flexible packaging, brand protection, sustainability and many other key industry issues. It has a controlled and audited readership of 11,000 industry professionals, chosen for their high levels of purchasing and decision making power. www.pci-mag.com PhaRMaCEuTiCal TEChnoloGy is used daily as a means of creating partnerships and as a point of reference by professionals within the pharmaceutical industry. This comprehensive resource supplies the latest news releases, detailed information on industry projects, white papers, event information and a thorough breakdown of products and services. www.pharmaceutical-technology.com WoRlD PhaRMaCEuTiCal FRonTiERs The pharmaceutical industry is changing fast. There World Pharmaceutical Frontiers www.worldpharmaceuticals.net Who should attend are more regulations, technologies, faster product launches and shorter Directors, VP’s, Managers, and Leaders of product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us ● Packaging, at www.worldpharmaceuticals.net and stay up to date with all latest ● Labeling, developments. ● Regulatory Affairs ● Engineers ThE BusinEss REViEW websites are your number one ● Specialists for Packaging and Labeling stop for all the latest news, comment and industry information. Each Business Review website offers ● Serialization Manager content that is produced by a dedicated team of journalists and global ● Technology specialists industry experts. In addition to the free content made available on the sites an intelligence store will provide you with premium market analysis reports from the leading global suppliers of market research and industry Do you wish to exhibit your products and services analysis. at this exclusive event? Pharmaceutical Business Review is the world's leading pharma If you want to be part of this leading industry event, website, being used by over 100,000 visitors every month. For further information contact jsharp@industryreview.com please contact Rizwan Qayum in our sponsorship team. Email: rizwanqayum@arena-international.com or call: MEDiCal ETRaCK is the new, interactive desktop tool designed for executives & +44 (0)20 7753 4259 analysts active in or supplying services to the medical equipment industry. www.medicaletrack.com
  • 6. Booking Form 2nd Annual Pharma Packaging and Labelling USA, Tuesday May 18 & Wednesday May 19 2010, Philadelphia, USA Before Before Before After Four Easy Ways To Book: Yes, I would like to register for the event: 19 February 16 March 16 April 16 April ■ Register online at Representatives from biotech and pharma companies www.arena-international.com/pharma/packagingusa I would like the VIP attendees package to include ■ Email us at events@arena-international.com the two day conference + Catalent’s Site Visit + $1629 $1729 $1879 $2129 ■ Tel +44 (0)20 7753 4268 interactive CD-ROM ■ Fax +44 (0)20 7915 9773 I would like to attend the two day conference + $999 $1099 $1249 $1499 Catalent’s Site Visit I would like to attend the two day conference + $1629 $1729 $1879 $2129 interactive CD ROM (Saving $70) Venue Details I would like to attend the two day conference only $999 $1099 $1249 $1499 The two day conference will take place on Tuesday May 18 All attendees and Wednesday May 19 2010. The venue for both days will be located in Philadelphia, USA. For further information contact Fees for all other attendees $2295 $2395 $2545 $2795 our Operations department on +44 (0)207 753 4201 I cannot attend the conference but would like to $499 $499 $499 $699 are you registered? receive the documentation You will always receive an acknowledgement of your booking. If you do not receive anything, please call us on +44 (0) 20 7753 4268 to make sure we have received your booking. Discount code if applicable _________________________________ Total Discounts are at the discretion of VIBevents and are not cumulative Alll total fees are subject to a 2.5% service charge. Arena International Events Group, a trading division of SPG Media Ltd. Registered Office: John Carpenter House, John Carpenter Street, London, EC4Y 0AN, UK. 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