KEY TAKEAWAYS FOR 2016 g VET MANAGE AND MAINTAIN PRIORITY STATUS WITH COMPATIBLE THIRD-PARTY VENDORS

g ADAPT NIMBLE MANAGEMENT STRATEGIES TO MEET CHANGING GLOBAL REGULATIONS AND COMPANY PREROGATIVES

g OUTLINE RECENT DEVELOPMENTS AND THE CURRENT TRAJECTORY OF THE DSCSA AND GLOBAL REGULATIONS

g ACTUALIZE RESPONSIBLE END-TO-END TRANSPARENCY AND EFFICIENT PRODUCT LIFE CYCLE MANAGEMENT

g LEVERAGE SERIALIZATION TO STREAMLINE SUPPLY CHAINS AND VALIDATE RETURNS TO WHOLESALERS

g INTEGRATE PACKAGING AND LABELING SYSTEMS TO ADDRESS CHANGING REQUIREMENTS

g LEARN HOW TO MANAGE ENTERPRISE-LEVEL AND ONLINE DATA EFFICIENTLY

g UNDERSTAND HOW IMPROVED TRANSPARENCY CAN MAKE SERIALIZATION PROFITABLE WITHOUT COMPROMISING SECURITY

Achieve US and Global Compliance and Product Integrity with Best Practices in Serialization and Packaging

Anand VardhanSenior IT Manager Supply Chain Integration and Information ABBVIE

May 10-11 2016 bull Hilton Parsippany bull Parsippany NJHEAR CASE STUDIES AND MORE FROM OUR EXPERT FACULTY

Bill FletcherManaging PartnerPHARMA LOGIC SOLUTIONS

Earlene GibbonsSenior Director Operational TechnologyUNITED THERAPEUTICS

Dave MasonGlobal Program Serialization LeadSANDOZ

Bjoern Rosner Associate Director Global Brand Protection BIOGEN

Gene HackettDirector of Corporate Security BRISTOL-MYERS SQUIBB

Chirag Shah Director Product Security and Supply Chain RiskSANOFI US

TRACEABILITY AND THE DRUG QUALITY

AND SECURITY ACT CONFERENCE

6th

TO REGISTER CALL 866-207-6528 OR VISIT WWWEXLEVENTSCOMTRACEABILITY

DEAR COLLEAGUE

The shifting sands of serialization regulations are no longer only on the horizon mdash they

are also underfoot An increasing number of countries are adding and changing their

regulations and no two countries have the same expectations or regulatory timelines

As a life science organization your companyrsquos success will be determined by how

swiftly you navigate this uncertain terrain

The 6th Traceability and the DQSA Conference is designed to guide you to implement

and execute a comprehensive and nimble serialization initiative that serves your

companyrsquos goals Attendees will learn strategies and adaptations necessary to change

global timelines and to satisfy a myriad of regionally nuanced regulations around the

globe In addition to providing up-to-date regulatory developments this conference will

give you hands-on education by showcasing lessons learned and case studies on pilot

programs

This event now in its sixth year will focus on achieving national and global compliance

product integrity and maximum profitability through masterful data management

and strategic labeling and packaging decisions ExL Events is proud to continue our

tradition of helping you strengthen your brand and combat counterfeiting through

serialization Join us to synthesize information on best practices the latest regulatory

updates and available resources

I look forward to welcoming you to Parsippany in May

Brian L Anderson

Brian L AndersonConference Production Director

WHO SHOULD ATTENDThis conference is designed for professionals within pharmaceutical companies wholesalers and pharmacies with responsibilities in the following areas

bull Serialization bull Supply Chain Management bull Brand ProtectionIntegrity bull Supply Chain Integrity bull Legal Affairsbull Track and Trace bull Anti-Counterfeitingbull Packaging Technology bull Packaging Engineering bull Authentication bull Validation bull Distribution bull Traceabilitybull Regulatory Affairsbull Logisticsbull Delivery Management bull Brand Management bull Product Safety and Securitybull ITIS Solutionsbull Pharmacy StrategySupplybull Logisticsbull Corporate Securitybull Customer Supplybull Recalls and Unsalables

This event may also be of interest to

bull Traceability Solution Providersbull Consultancies bull Contract Packaging Organizationsbull Drug Manufacturing Companies

SPONSORSHIP AND EXHIBITION OPPORTUNITIES Do you want to spread the word about your organizationrsquos solutions and services to potential clients who attend this event Take advantage of the opportunity to exhibit present an educational session host a networking event or distribute promotional items to attendees ExL works closely with you to customize a package that suits all of your needs To learn more about these opportunities contact David Borrok Senior Business Development Manager at 212-400-6234 or dborrokexleventscom

VENUE INFORMATION HILTON PARSIPPANY1 Hilton Court

Parsippany NJ 07054

To make reservations please call 800-445-8667 and request the negotiated rate for ExLrsquos 6th TraceabilityOff-Label Meetings You may also make reservations online using the following weblink httpbitly1Jkyw21 The group rate is available until April 18 2016 Please book your room early as rooms available at this rate are limited

ExL Events Inc is not affiliated with Exhibition Housing Management (EHM)Exhibitors Housing Services (EHS) or any third-party booking agencies housing bureaus or travel and events companies In the event that an outside party contacts you for any type of hotel or travel arrangements please disregard these solicitations and kindly email us at infoexleventscom ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered Please book your guest rooms through ExLrsquos reserved guest room block using the details provided

1200 Registration for Main Conference

100 Chairpersonrsquos Opening Remarks

BRAND PROTECTION

115 Manage Security Issues with Brand Protection and Anti- Counterfeiting

bull Establish the challenges and needs of a company bull Determine strategies and tactics to leverage serializationbull Estimate the individual relationships and vendor partnerships

necessary to go beyond compliance bull Calculate the capital investment necessary to achieve goalsbull Vet technologies with rubrics crafted to assess viability and

efficacy Gene Hackett Director of Corporate Security BRISTOL-MYERS SQUIBB

200 Leverage Serialization Data to Create Brand and Security Value

bull Improve master data management to add value to a brandbull Leverage serialization spend to upgrade packaging lines and

influence distribution strategybull Manage returns processes and recallsbull Maximize security value by improving reconciliation and end-of-

life processesbull Enable supply chain authenticationbull Gather field intelligence through end-user authentication and

diversion trackingBjoern Rosner Associate Director Global Brand Protection BIOGEN

245 Networking Break

315 Add Value by Augmenting Serialization for Brand Protection and Anti-Counterfeiting

bull Institute strategies and tactics to leverage serialization through a study of emerging markets

bull Extract pertinent lessons from incidents experiences and regulations relevant to brand protection in Asia-Pac

bull Determine system attributes for product authenticationbull Examine key junctures of serialization brand protection and anti-

counterfeiting for optimal integrationbull Calculate capital investment and other resources necessary to

achieve goals bull Establish a companyrsquos challenges and needsbull Estimate the partnerships necessary to go beyond compliancePankaj Monga Director Brand Protection Asia JOHNSON amp JOHNSON

HUMAN RESOURCE ALLOCATION AND MANAGEMENT

400 PANEL Compose Teams Develop Staff and Garner Resources to Maximize Profit and Ensure Compliance

bull Compare your companyrsquos personnel structure relative to alternative serialization staffing choices and personnel allocations

bull Assess the hard and soft skill sets of teams responsible for effecting and managing serialization

bull Develop the technological savvy and emotional intelligence of serialization leaders and professionals

bull Facilitate internal and external cross-functional teams to manage serialization and provide guidance

Panelists Chirag Shah Director Product Security and Supply Chain Risk SANOFILydia Hemphill Manager Supply Chain Business Operations BIOMARIN PHARMACEUTICAL

445 Ensure Optimal Team Composition and Staff Development Engagement to Comply with and Profit from Serialization

bull Determine optimal team mechanics and composition to institute serialization by reviewing alternative models

bull Identify the model of outsourcing that will meet and complement the ability and capacity of internal resources

bull Create a checklist and conduct an inventory of the hard and soft skill sets of professionals charged with planning and executing serialization

bull Achieve buy-in by assembling a cross-functional advisory team with internal allies and external representatives

Dave Mason Global Program Serialization Lead SANDOZ

530 Day One Concludes

800 Registration and Continental Breakfast

900 Global Strategy for Pharmaceutical Traceability Serialization Track and Trace Unique Device Identifiers (UDI) and Electronic Data Interchange

Whether you are developing your road map for serialization or have already implemented your serialization system this workshop will acquaint you with the global regulatory landscape Participants will receive guidance on how and where to focus their efforts and learn key takeaways from pilot and case studies bull Learn background and recent developments related to the DQSA bull Examine national and global regulations and timelinesbull Review global regulatory nuances in particular serialization laws in the US China the EU and India bull Comply with US law and meet the 2017 deadlinebull Develop tools and techniques to satisfy UDI regulatory standardsbull Hone your teamrsquos ability to shift its focus and direction by incorporating nimble structures and responsive protocols

This workshop includes a 30-minute networking break

Bill Fletcher Managing Partner PHARMA LOGIC SOLUTIONS

1200 Luncheon for Workshop Attendees

MAIN CONFERENCE DAY ONE TUESDAY MAY 10 2016

PRE-CONFERENCE WORKSHOP TUESDAY MAY 10 2016

TO REGISTER CALL 866-207-6528 OR VISIT WWWEXLEVENTSCOMTRACEABILITY

1200 Registration for Main Conference

100 Chairpersonrsquos Opening Remarks

BRAND PROTECTION

115 Manage Security Issues with Brand Protection and Anti- Counterfeiting

bull Establish the challenges and needs of a company bull Determine strategies and tactics to leverage serializationbull Estimate the individual relationships and vendor partnerships

necessary to go beyond compliance bull Calculate the capital investment necessary to achieve goalsbull Vet technologies with rubrics crafted to assess viability and

efficacy Gene Hackett Director of Corporate Security BRISTOL-MYERS SQUIBB

200 Leverage Serialization Data to Create Brand and Security Value

bull Improve master data management to add value to a brandbull Leverage serialization spend to upgrade packaging lines and

influence distribution strategybull Manage returns processes and recallsbull Maximize security value by improving reconciliation and end-of-

life processesbull Enable supply chain authenticationbull Gather field intelligence through end-user authentication and

diversion trackingBjoern Rosner Associate Director Global Brand Protection BIOGEN

245 Networking Break

315 Add Value by Augmenting Serialization for Brand Protection and Anti-Counterfeiting

bull Institute strategies and tactics to leverage serialization through a study of emerging markets

bull Extract pertinent lessons from incidents experiences and regulations relevant to brand protection in Asia-Pac

bull Determine system attributes for product authenticationbull Examine key junctures of serialization brand protection and anti-

counterfeiting for optimal integrationbull Calculate capital investment and other resources necessary to

achieve goals bull Establish a companyrsquos challenges and needsbull Estimate the partnerships necessary to go beyond compliancePankaj Monga Director Brand Protection Asia JOHNSON amp JOHNSON

HUMAN RESOURCE ALLOCATION AND MANAGEMENT

400 PANEL Compose Teams Develop Staff and Garner Resources to Maximize Profit and Ensure Compliance

bull Compare your companyrsquos personnel structure relative to alternative serialization staffing choices and personnel allocations

bull Assess the hard and soft skill sets of teams responsible for effecting and managing serialization

bull Develop the technological savvy and emotional intelligence of serialization leaders and professionals

bull Facilitate internal and external cross-functional teams to manage serialization and provide guidance

Panelists Chirag Shah Director Product Security and Supply Chain Risk SANOFILydia Hemphill Manager Supply Chain Business Operations BIOMARIN PHARMACEUTICAL

445 Ensure Optimal Team Composition and Staff Development Engagement to Comply with and Profit from Serialization

bull Determine optimal team mechanics and composition to institute serialization by reviewing alternative models

bull Identify the model of outsourcing that will meet and complement the ability and capacity of internal resources

bull Create a checklist and conduct an inventory of the hard and soft skill sets of professionals charged with planning and executing serialization

bull Achieve buy-in by assembling a cross-functional advisory team with internal allies and external representatives

Dave Mason Global Program Serialization Lead SANDOZ

530 Day One Concludes

800 Registration and Continental Breakfast

900 Global Strategy for Pharmaceutical Traceability Serialization Track and Trace Unique Device Identifiers (UDI) and Electronic Data Interchange

Whether you are developing your road map for serialization or have already implemented your serialization system this workshop will acquaint you with the global regulatory landscape Participants will receive guidance on how and where to focus their efforts and learn key takeaways from pilot and case studies bull Learn background and recent developments related to the DQSA bull Examine national and global regulations and timelinesbull Review global regulatory nuances in particular serialization laws in the US China the EU and India bull Comply with US law and meet the 2017 deadlinebull Develop tools and techniques to satisfy UDI regulatory standardsbull Hone your teamrsquos ability to shift its focus and direction by incorporating nimble structures and responsive protocols

This workshop includes a 30-minute networking break

Bill Fletcher Managing Partner PHARMA LOGIC SOLUTIONS

1200 Luncheon for Workshop Attendees

MAIN CONFERENCE DAY ONE TUESDAY MAY 10 2016

PRE-CONFERENCE WORKSHOP TUESDAY MAY 10 2016

TO REGISTER CALL 866-207-6528 OR VISIT WWWEXLEVENTSCOMTRACEABILITY

800 Continental Breakfast

915 Chairpersonrsquos Recap of Day One

SUPPLY CHAIN

930 Extract Lessons Streamline Processes and Cut Costs from Pilot Studies and Case Studies

bull Limit metrics to focus on the factors most relevant to your companyrsquos serialization objectives

bull Engage vendors in frequent meetings to assess and improve performance and process

bull Select vendor-informed solution providers hardware and software

bull Refine data management and business processesbull Effect data sharing that is transparent yet secureMichael Daly Director Supply Chain VALEANT PHARMACEUTICALS

1015 PANEL Avoid Supply Chain Capacities Constraining Growth

bull Discuss key considerations and the potential business benefits of serialization

bull Account for the additional time and resources needed to fulfill the traceability obligations of manufacturers CPOs warehousers and distributors in contract negotiations

bull Incorporate feedback from distributors wholesalers warehousers and retailers

bull I mprove efficiency by examining logistics to ldquolessonrdquo the burden bull Consider the ramifications of technological decisions on external

partners ModeratorBill Fletcher Managing Partner PHARMA LOGIC SOLUTIONS PanelistsShaun Kirkpatrick Manager Track and Trace Operations GLAXOSMITHKLINE

1100 Networking Break

DATA INNOVATION AND TECHNOLOGY

1130 Optimize Your Companyrsquos IT Architecture to Enable Serialization

bull Vet technologies conducive to optimal knowledge management bull Increase transparency to ensure compliance and profitabilitybull Scrutinize your solution providerrsquos ability and capacity to meet

your needs and timelinebull Gauge alternatives andor resources to mitigate gaps and

inefficiencies bull Garner resources from executives by demonstrating the value of

secure and coherent serialization systemsAnand Vardhan Senior IT Manager Supply Chain Integration and Information ABBVIE

1215 Luncheon

115 Determine Your Optimal Labeling and Packaging Option to Achieve Compliance and Company Goals

bull Explore the merits and drawbacks of various optionsbull Determine your serialization solution using software created

internally or by a vendorbull Weigh the vendorrsquos benefit-risk profile against DIY cost savings bull Establish your hierarchy of needs and goals for your serialization

programbull Contemplate the advantages of greater investment in labeling

beyond serialization compliancebull Learn the ramifications of using 2D or RFID labels on packaging

and labeling

PARTNERSHIPS AND COLLABORATION

200 CASE STUDY Select an EPCIS Vendor Suited to the Scope of Your Serialization Program

bull Benchmark the objectives and business justification for your serialization program

bull Evaluate vendors for their bandwidth and ability to provide necessary and timely services

bull Document and convey the requirements for successful partnerships

bull Assemble a project team with attention to the skill sets necessary to execute serialization

bull Prepare for implementation using established protocols and systems

Herschel Kenney Senior Director IT Applications ACORDA THERAPEUTICS

245 CASE STUDY Manage Multiple Vendors and Integrate Technologies to Maximize Efficiency

bull Orchestrate the engagement of disparate solution providers to work in concert on your serialization initiative

bull Integrate technologies and systems for data aggregationbull Establish premium service in the client hierarchy of third-party

vendorsbull Maintain fidelity to overlapping timelines for multiple line rolloutsEarlene Gibbons Senior Director Operational Technology UNITED THERAPEUTICS

330 Chairpersonrsquos Closing Remarks

345 Conference Concludes

MAIN CONFERENCE DAY TWO WEDNESDAY MAY 11 2016

ldquoEXCELLENT EVENT AND SPEAKERSrdquo mdashDirector Commercial Productions ACORDA THERAPEUTICS

ldquoPRACTICAL RELEVANT POINTERS FOR A SUCCESSFUL STRATEGIC PROGRAMrdquo mdashProgram Manager MALLINCKRODT PHARMACEUTICALS

ldquoVERY GOOD INSIGHT INTO IMPLEMENTING [A] GLOBAL PROGRAMrdquo mdashDirector Commercial Supply Chain CELGENE

TO REGISTER CALL 866-207-6528 OR VISIT WWWEXLEVENTSCOMTRACEABILITY