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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
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
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
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
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
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