ViBpharma

Pharma Packaging and labeling usa

KEy BEnEFiTs FoR aTTEnDinG:

• Hear 18 unique end user case studies from the front line of pharma packaging and labeling

• Discover the latest cost eff ective strategies for achieving your company’s sustainability goals

• Uncover critical developments in serialization and the implications for your company

• Defi ning how electronic labeling will benefi t you and reduce the labeling costs for your company

• Analyze essential strategies that will help you reduce waste & drive effi ciency through your packaging and labeling activities

nETWoRK WiTh inDusTRy WoRlD lEaDERs inCluDinG:

Register online now at: www.arena-international.com/pharma/packagingusa

2nd Annual

hEaR FRoM inDusTRy WoRlD lEaDERs inCluDinG:■ Ron GuidoVice President Global Brand ProtectionJohnson & Johnson

■ James haganVice President sustainability and EnvironmentGlaxosMiThKlinE

■ Gerald Miller Packaging Engineer – Global Product ProtectionEli lilly anD CoMPany

■ William Bosleylabeling specialist, Proprietary aff airs labeling WaTson PhaRMaCEuTiCals inC

■ arminda o. MonteroDistribution Qa Program Manager strategic Quality initiativesaBBoTT laBoRaToRiEs

■ Charles listigoverssenior Director Global Manufacturing TechnologysanoFi PasTEuR

■ Daniel l. norwood, Ph.D.Distinguished Research FellowBoEhRinGER inGElhEiM PhaRMaCEuTiCals, inC.

■ Tonja hamptonDirector Worldwide Product labelingMERCK & Co

Lead Sponsor: Silver Sponsor:

Post Conference Site Visit led by Catalent – Pharma solutions for your printed component challenges. Free for Pharmanufacturers & Biotechs

your packaging and labeling your packaging and labeling

Catalent would be delighted if you could join them for a

drinks reception at the end of day one

■ GlaxosmithKline ■ Johnson & Johnson ■ Merck & Co inc ■ Eli lilly and Company

■ Packaging science Resources

■ Boehringer ingelheim Pharmaceuticals, inc.

■ Gs1 healthcare us■ Watson

Pharmaceuticals inc ■ alpharma inc

■ Genzyme Corporation■ sanofi Pasteur ■ abbott laboratories

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

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

Program Day One Tuesday 18 May 2010

11:30 sustainability Panel: strategies to meet your organizations sustainability goals – uncovering benchmarking opportunities

Assessing the three top materials to endorse in your packaging ●

strategy that will encourage sustainability eff orts Evaluating the best labeling strategy that will guarantee ●

sustainability improvements Identifying the most successful examples of sustainable sources ●

used in Pharma Deciding on realistic achievable sustainability goals and putting a ●

strategy in place to meet those Overcoming challenges in current technology; identifying when ●

investment is required Determining which has the biggest environmental impact – ●

process changes, reduction of material, or simplifi cation of packaging? Mathew Thomas, Team leader – Packaging Development, Eli lilly & CoMPany

12:30 Lunch and networking

08:30 Registration and refreshments

08:55 Chairman’s opening remarks: Victor Dixon, Vice President and General Manager, Printed Components, CaTalEnT

Critical insights on compliance with current FDa regulation and international requirements to help you develop your strategy in the next 12 – 18 months 09:00 Keynote Presentation:

Ensuring you are compliant in a world of constantly changing regulations – reviewing the regulatory landscape and what you can expect in the coming year

Analyzing the requirements of the Physician Labeling Rule and ●

how they are being met 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 ●

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 upgradePreparing your business for a successful implementation ●

Ensuring the supply chain is ready for serialization ●

Ron Guido, Vice President Global Brand Protection, Johnson & Johnson

10:00 Preparing for serialization and visibility within the us pharmaceutical supply chain

Gain insights on the benefi ts of a fully implemented supply chain ●

using GS1 Visibility Standards Utilize simulated supply chain processes to: ●

- test exception processes to minimize implementation surprises - decrease the need for trading partner pilots - generate GS1 standardized data to test your systems- test new concepts and data to discover additional benefi ts Reducing implementation costs – helps to resolve majority of ●

issues prior to implementation with trading partners Provides confi dence that an organization’s implementation is ●

“trading partner ready”Provides confi dence that a company’s trading partners are ready ●

Take the lead in helping to develop a U.S. Pharmaceutical Supply ●

Chain Reference Model to support industry-wide implementation Bob Celeste, Director, Gs1 hEalThCaRE us

10:30 Morning refreshments and networking

Developing strategies for sustainability in packaging and labeling that can cut costs and enhance your company’s green credentials 11:00 Defi ning sustainability and how you can measure it

eff ectively to guarantee a winning strategy you can adopt when addressing the issue

Determining if renewable sources such as paper are the only ●

materials deemed sustainable Understanding how plastics and other materials can be made ●

environmentally friendly as renewable sources if treated correctly Evaluating the impact of electronic labeling on your sustainability ●

stanceAssessing feasibility of switching from pvc to other polymers ●

Evaluating the manufacturing process and the systematic ●

approach that drives sustainability eff orts before the end result is even achieved How can pack standardization reduce the environmental footprint ●

of packaging?James hagan, Vice President sustainability and Environment, GlaxosMiThKlinE

Established for over 20 years, Packaging Today provides Europe’s packaging professionals with an unrivalled mix of news, in-depth features, opinion and analysis on key factors affecting their industry. With a pan-European circulation of 15,000 every month, the magazine provides up-to-date information on the latest business news, as well as developments in machinery, packaging materials and packs.

Apply for your FREE subscription today visit, www.packagingtoday.co.uk

Converting Today, Europe’s leading magazine for buyers and specifi ers of converting machinery, materials and services, provides in-depth features and all the latest industry news from around the world. Published monthly, Converting Today keeps thousands of key industry people up-to-date on developments in technology and trends, as well as the latest business news.

Apply for your FREE subscription today visit, www.convertingtoday.co.uk

Europe’s Packing Magazine

Packaging and Converting Intelligence delivers essential expert verdicts on all sectors within the packaging industry, including food, beverage, cosmetic and personal care packaging sectors. Within each section there is detailed focus on folding cartons and cardboard, printing and labelling, fl exible packaging, brand protection, sustainability and many other key industry issues.

Apply for your FREE subscription today visit, www.pci-mag.com

2:00 Determining which anti-counterfeiting technologies to use in protecting your product

Defining the problem ●

Additional information to consider ●

Special considerations for the Pharmaceutical Industry ●

Possible Solutions ●

Gerald Miller, Packaging Engineer – Global Product Protection, Eli lilly anD CoMPany

2:30 The Regulatory Environment for Extractables and leachables – implications for packaging technology

Understanding the current regulatory environment for extractables ●

and leachables (US and EU) Best practices for assessing extractables and leachables – case ●

studies Packaging and container closure system component selection ●

Current industry initiatives and their implications for the future ●

Daniel l. norwood, Ph.D., Distinguished Research Fellow, BoEhRinGER inGElhEiM PhaRMaCEuTiCals, inC.

3:00 assessing and selecting anti tamper packaging options

Defining the problem ●

Types of solutions available and possible FDA requirements ●

Use of Physical/Chemical Identifiers (testing to ensure safety of use) ●

Impact of implementing tamper evidence within manufacturing ●

Evaluating relative cost of tamper evident options ●

amy l s Vangeloff, Global Manufacturing Product Protection Team leader, Eli lilly anD CoMPany

3:30 Afternoon refreshments and networking

4:00 assessing how cost effective it is to remove certain materials from packaging while not compromising on the safety of the drugs

Reviewing how removing unit curtains can substantially reduce ●

packaging costs How likely is it that the stock will be damaged by removing certain ●

packaging material? Evaluating how removing materials from packaging can help you ●

achieve sustainability goals Determining how reducing packaging while cutting costs can be ●

achieved without employing overtly expensive technologies

4:30 innovative packaging techniques that ensure packages are both child resistant and elderly person friendly

Achieving a balance between child resistance and elderly friendly ●

packaging Analyzing the cost of purchasing new technology that will streamline ●

the processDefining the vision for how packaging is going to develop in this arena ●

Evaluating the best recent examples of innovative packaging options ●

that meet both of these goals at once

2:00 Examining Electronic labeling and industry/Consumer impact

History and current position of electronic labeling initiatives ●

Reducing costs throughout with paperless package inserts – SKU, ●

inventory, and life cycle management Update labeling in-market and possibly avoid recalls ●

Reduce time to market requirements and eliminate distribution lag ●

time Enhance ability to ensure labeling in market is always up-to-date ●

Current opposition to paperless labeling ●

Impact of paperless labeling and special considerations ●

William Bosley, labeling specialist, Proprietary affairs labeling, WaTson PhaRMaCEuTiCals inC

2:30 Electronic Drug listing/structured Product labeling – Compliance Considerations

eDRL/SPL Historical Situation, Perceived Need ●

Listing requirements new to SPL ●

Project Scope of Implementation ●

Alternatives for Achieving Compliance ●

Cost Considerations ●

What’s next in Electronic Initiatives? ●

Carol Garcia, Manager – Global labeling & Packaging, alPhaRMa inC

3:00 Minimizing packaging costs and reducing your company’s Co2 footprint through the adoption of electronic labeling while ensuring the label content is better than ever and easier for the pharmacists to assimilate and notice any new changes

Removing the various labels that currently go into each packet will ●

open the door for packets to be reduced in size saving resources and will afford a company to transport more at a time Content label can be updated at a fraction of the time it would ●

normally take because there will be no label printing time to adhere to which can take up to 12 months normally Labels can be more thorough and include additional information it is ●

currently unfeasible to place on a labelReduction in size of cold chain product packaging will save energy, ●

expense and the environment Theresa Brunone, assistant Director Global Regulatory operations, GlaxosMiThKlinE

3:30 Afternoon refreshments and networking 4:00 Evaluating the best options in advertising and promotional labelling

Evaluating cost effective promotional options ●

Developing a successful strategy to maximise ROI ●

Assessing popular options and evaluating their effectiveness ●

Analyzing new strategies – the pros and cons ●

Tammara lewis, Director advertising Promotion and labeling, GEnzyME CoRPoRaTion

4:30 understanding data mining – finding the most 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 One Tuesday 18 May 2010

Stream A: innovations in packaging design, manufacture and processing that increase efficiency reduce costs and minimize counterfeit risk

Stream B: innovations in labeling – maximizing patient safety, ensuring regulatory compliance and limiting costs

Program Day Two Wednesday 18 May 2010

08:30 Registration and refreshments

08:55 Chairman’s opening remarks

09:00 speaker hosted RoundtablesInteractive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Hosted by industry experts and each focused on a single issue, roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others. Delegates can attend up to 3 round tables and may select from:

RounDTaBlE 1: assessing anti-counterfeit technology options and tamper-evident techniques – reliability and affordability David howard, Director of Global Product Protection, Johnson & Johnson

RounDTaBlE 2: Establishing operational advantages of endorsing electronic labeling and what is necessary for it to work smoothly

RounDTaBlE 3: Keeping abreast with regulatory / legislation changes that need to be implemented on existing labeling and developing efficient methods to help you achieve themTonja hampton, Director Worldwide Product labeling, MERCK & Co

11:00 Morning refreshments and networking

11:30 RounDTaBlE 4: Defining technology options that will help you gain sustainability credentials while saving you costs overall

Cost effective strategies to guard against counterfeit medicines, to protect your brand and safeguard the patient 12:30 Determining the best anti-counterfeit supply chain

options you can implement to ensure medicine package traceability

A deep dive into how RFID tagging can help guard against ●

counterfeit medication Evaluating the advantages of using Data Matrix codes on ●

packages Fighting drug diversion by maximizing supply chain visibility ●

Determining the most common failures that allow counterfeit ●

medication to enter the supply chain and how you can best addressed them

1:00 Defining anti-counterfeiting strategies and technologies

Evaluation of the global supply chain ●

Assessment of strategic elements ●

Explore technologies for a successful program ●

Serialization – comparing RFID and 2D bar codes ●

James Pierantozzi, Consultant – Pharmaceutical Packaging, recently retired from WyETh

1:30 Lunch and networking

2:30 analyzing affordable anti-counterfeit technology options that pharma can take advantage of

Identifying the drivers of counterfeiting in the US and strategies ●

to combat the main sources Evaluating available anti-counterfeiting strategies and assessing ●

which one is the most suitable to adopt Understanding how anti-counterfeit technology will impact the ●

pharmaceutical industry Assessing serialization and track and trace technologies you can ●

implement Determining the best preventative and authentication ●

technologies

3:00 PanEl sEssion: evaluating strategies for the successful implementation of E-Pedigree

Mapping the vision for E-pedigree in the US over the next 2-3 ●

years Identifying the role E-pedigree will play in combating counterfeit ●

medication in the US Assessing the cost of E-pedigree implementation on a large to ●

medium scale Pharma company Establishing the main challenges involved in the implementation ●

of E-pedigree & strategies to overcome these Michael Ventura, serialization Business lead, GlaxosmithKline Charles listigovers, senior Director, Global Manufacturing Technology, sanoFi PasTEuR

3:30 Afternoon refreshments and networking

Evaluating cold chain strategies for packaging and labeling that ensure the integrity of the cold chain from manufacturer to end user 4:00 Cold Chain packaging – addressing Real-World

Distribution Challenges and Regulatory ExpectationsDesign Considerations – understanding product requirements, ●

ambient temperature profiles, shipping process Qualification Guidance – from design qualification to operational ●

qualification to performance qualification Post-Qualification Performance – meeting product requirements ●

and regulatory expectations What’s Next? – controlled-room temperature products (product ●

stability, packaging, transportation)arminda o. Montero, Distribution Qa Program Manager strategic Quality initiatives, aBBoTT laBoRaToRiEs

4:30 Distribution of Products at liquid nitrogen Temperatures – Challenges and solutions

What shipping and storage containers are available? ●

What are the current distribution logistics? Who is able and ●

willing to transport these products? What is required by hospitals, clinics, pharmacies and other ●

patient administration sites to receive and store these products? What unique risks and costs do very low temperature products ●

present? Dr Edward J. smith Ph.D., Principle Consultant, PaCKaGinG sCiEnCE REsouRCEs

5:00 Defining the labeling challenges surrounding cold chain products and how to overcome those

Developing a label that will endure temperature extremes intact ●

Generating a label that will ensure the product is globally ●

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

lead sponsor:CaTalEnT PhaRMa soluTions Solutions is the only global, full service pharmaceutical printed component supplier with an integrated network of packaging operations. Catalent has multiple facilities in the US, Puerto Rico and Europe dedicated to the pharmaceutical healthcare industry. With unique printing capabilities, Catalent can satisfy customer demand for folding cartons, blister cards, inserts/outserts, pharmaceutical labels, clinical trial case reports, and pharmaceutical patient information materials printing. These extensive capabilities enable manufacturers to simplify their supply chains by using a single source for all components, maintain consistent quality across their products, and leverage economies of scale off ered by multiple sites and capabilities.Catalent is a true turnkey provider with an integrated network for pharmaceutical printed components and packaging services, and is well positioned to serve you, wherever you do business. www.catalent.com

silver sponsor:PRisyM iD works with many of the world’s largest pharmaceutical and medical device companies, providing validated life sciences labelling management 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 designed labelling management software for FDA regulated environments. Compliant Labeling Solutions www.prisymls.com

Media Partners:PaCKaGinG GaTEWay PaCKaGinG executives from around the world use Packaging Gateway to keep abreast of the latest industry developments and to make informed purchasing decisions throughout the entire supply chain. www.packaging-gateway.com

PaCKaGinG & ConVERTinG inTElliGEnCEPackaging and Converting Intelligence delivers essential expert verdicts on all sectors within the 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, fl exible 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 are more regulations, technologies, faster product launches and shorter product life cycles than ever before. World Pharmaceuticals frontiers is, and will continue to be, at the forefront of these changes, so visit us at www.worldpharmaceuticals.net and stay up to date with all latest developments.

ThE BusinEss REViEW websites are your number one stop for all the latest news, comment and industry information. Each Business Review website off ers content that is produced by a dedicated team of journalists and global 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 analysis.

Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors every month.

For further information contact jsharp@industryreview.com

MEDiCal ETRaCK is the new, interactive desktop tool designed for executives & analysts active in or supplying services to the medical equipment industry. www.medicaletrack.com

Do you wish to exhibit your products and services at this exclusive event?If you want to be part of this leading industry event, please contact Rizwan Qayum in our sponsorship team. Email: rizwanqayum@arena-international.com or call: +44 (0)20 7753 4259

Who should attendDirectors, VP’s, Managers, and Leaders of

Packaging, ●

Labeling, ●

Regulatory Aff airs ●

Engineers ●

Specialists for Packaging and Labeling ●

Serialization Manager ●

Technology specialists ●

POST-CONFERENCE WORKSHOP

The post-conference Catalent site visit – Pharma solutions for your printed component challenges Thursday May 20, 2010Led by: Victor Dixon, Vice President and General Manager, Printed Components, Catalent

about the workshop:This on-site interactive workshop at Catalent’s printed component site in New Jersey, just across the river from Philadelphia, will demonstrate the solutions and technologies necessary to ensure that your cartons, labels and inserts/outserts are of the highest quality and are produced in the most effi cient manner. You will also be given a live demonstration of their e-magineering services and capabilities and other technology solutions

World Pharmaceutical Frontiers www.worldpharmaceuticals.net

Workshop agenda:09:30 Bus Transfer to Catalent’s facilities

10:00 Welcome to delegates by Victor Dixon10:15 Guided tour of Catalent’s printed component

site

11:00 Presentation of core technologies and solutions

12:00 Question and answer session

12:30 Lunch reception

13:45 End of site visit and bus transfer back to the hotel

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Venue DetailsThe two day conference will take place on Tuesday May 18 and Wednesday May 19 2010. The venue for both days will be located in Philadelphia, USA. For further information contact our Operations department on +44 (0)207 753 4201

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2nd Annual Pharma Packaging and Labelling USA, Tuesday May 18 & Wednesday May 19 2010, Philadelphia, USA

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I would like the VIP attendees package to include the two day conference + Catalent’s Site Visit + interactive CD-ROM

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