november 30th - december 2nd, 2016 pharmaceutical ... · abbott laboratories director, pharmacy...

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November 30th - December 2nd, 2016 • Philadelphia, PA

Flip over to Page 2 to see details on our expert speaking faculty!

FINE-TUNING YOUR SERIALIZATION STRATEGIES to meet global deadlines & achieve item-level traceability

www.PharmaceuticalTraceabilityForum.com • 1-800-882-8684 • [email protected]

IMPLEMENT IMPROVE INNOVATE

Sponsored by:

DATA EXCHANGE: How are you preparing to

seamlessly transfer data between supply chain partners?

EMERGING MARKETS: Are you ready for new requirements coming out of Russia, Brazil, India,

and the Middle East?

INTERNATIONAL STRATEGY:How are you working with your solutions providers to create a globally adaptable

serialization plan?

LINE-LEVEL EFFICIENCY: Are upgrading your packaging & labeling lines to meet all global deadlines to avoid

shipment delays?

AGGREGATION: Did you decide to aggregate,

and what do your downstream partners require?

Media Partners:

CONTRACT PARTNER READINESS:

Are your CMOs & CPOs on track to meet the 2017 DSCSA deadlines?


MEET OUR EXPERTS!

Matt Sample Senior Director, Secure Supply Chain Amerisource Bergen

Scott Mooney Vice President of Distribution Operations McKesson

Maarten Van Baelen Market Access Director Medicines for Europe

Ben Locwin, Ph.D, MBA Director of Business Strategy, Operations, and Performance/ President Biogen/ Healthcare Science Advisors

David Mason Global Program Serialization Lead Sandoz

Dr. Jeanne M. Sirovatka, Ph.D, MBB Director, Continuous Improvement Fresenius Kabi USA, LLC

Scott Hall Director Package Engineer & Product B. Braun Medical Health

Shaun Kilpatrick Trace & Trace Operations Manager GlaxoSmithKline

Damian Rodriguez Package Engineering Specialist B. Braun Medical Health

John Woodburn Global Serialization Solution Lead Sanofi

Quentin Dittman Director, Operations Technology and Track and Trace Cardinal Health

Kevan MacKenzie Director, Serialization Technology McKesson

Mike Wallace Former Director, Global Standards & Serialization Abbott Laboratories

Brian Files Director, Pharmacy Inventory Management CVS Health

Brian Tarantino Director, Serialization Strategy Merck

Chris Smith Director Federal Public Policy National Association of Chain Drug Stores (NACDS)

Christopher Howell Senior Director, Global Engineering & Technology Patheon Inc.

Peter Sturtevant Sr. Director Industry Development GS1US

Joe Whyte Director Serialization & Connected Enterprise Solutions Rockwell Automation

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ADVISORY BOARD MEMBERS

MEET OUR SPEAKING FACULTY

“The IQPC Serialization forum is a great opportunity to engage with solution teams from across the pharmaceutical industry as we work to enhance the security of the US supply chain and meet the requirements of the DSCSA.”

“IQPC provides a unique opportunity to engage some of the smaller members of the supply chain that we as a large wholesaler don’t communicate with frequently. Their engagement in DSCSA is just as critical.”

“Determine your serialization strategy by networking with all the critical players across the supply chain.”

“Contacts are key for our industry as we must conduct pilots where we exchange Traceability Data for serialized product and the physical serialized product”

www.PharmaceuticalTraceabilityForum.com • 1-800-882-8684 • [email protected] www.PharmaceuticalTraceabilityForum.com • 1-800-882-8684 • [email protected]

Dear Colleague,

The time is now! If you have been procrastinating in your serialization efforts, then you are already behind. A “wait and see” approach to DSCSA and international deadlines is no longer an option. Action is required.

In order to stay competitive, all supply chain stakeholders need to take an industry-wide approach to key challenges such as data transfers, aggregation, saleable returns, and packaging & labeling initiatives. Pilot programs are allowing for this collaboration to occur which have led to crucial breakthroughs to advance the industry. Together, partner organizations can set standard operating practices to streamline the transfer of serialized product throughout the supply chain. Even with recent progress, there are still many challenges looming in the near future. DSCSA’s 2023 requirement may seem far away, but the steps taken now will help prepare to reach that deadline. Be proactive, learn from your peers, and adapt strategies that have proven valid into your own operations

Still looking to gain clarity? Luckily, our program has brought together the sharpest minds in the industry to guide you through the ever-changing serialization landscape.

Join them to:

• Examine international regulation updates in markets such as Brazil, India, and the Middle East

• Streamline your CMO/CPO integration into your serialization plans

• Review an approach to aggregation and saleable returns from a wholesaler & manufacturing perspective

• Determine an optimal strategy for updating your packaging & labeling lines for serialization

• Achieve data interoperability throughout the supply chain and with global suppliers

• Explore innovative solutions to create value from your costly investment into serialization

• Ensure your teams are well-versed in the new technology being implemented for serialization

• Understand the full scope of challenges faced by dispensers and how upstream partners can aide in their efforts

Through our innovative speaking sessions, interactive panel discussions, candid roundtables, and ample time for networking, you will be poised to surpass every deadline with ease and begin to use your serialization program to achieve both commercial and intrinsic value. Wouldn’t you like to look back at this time and be able to say you were at the forefront of creating true patient safety through traceability? Join us to be a part of the solution that will shape the future of the industry.

I look forward to meeting you in Philly!

Best,

Jody Tropeano Program Director

To kick off Main Day Two, we will be co-locating

our first 4 sessions with the 2nd Pharmaceutical

Packaging & Labeling Forum!

Past Event Attendees Include:

November 30th - December 2nd, 2016 Philadelphia, PA

AbbVie Inc.

Acorda Therapeutics

Alexion Pharmaceuticals

Alkermes

Allergan

AmerisourceBergen Corporation

Amgen

ANI Pharmaceuticals

Apotex Corporation

B Braun Medical Inc

Brigham Women’s Hospital

Bristol-Myers Squibb

Cardinal Health

Celgene

CVS Health

Egalet

Eli Lilly and Company

EMD Serono, Inc

Endo Pharmaceuticals

FORUM Pharmaceuticals

Franciscan Missionaries of Our Lady Health System

Fresenius Kabi

GlaxoSmithKline

Golden State Medical Supply Inc.

GS1 US

Intarcia Therapeutics

Intermountain

Healthcare

Ipsen Biopharmaceuticals

Jazz Pharmaceuticals

Kaiser Permanente

Keryx Biopharmaceuticals Inc

L. Perrigo Company

Lexicon Pharmaceuticals

McKesson

Merck & Co. Inc.

MIT Center for Biomedical Innovation

National Community Pharmacists Association

NorthStar Healthcare

Novartis

Noven Pharmaceuticals

Piramal Critical Care

Pfizer

Quinn Pharmaceuticals

Radius Health, Inc.

Regeneron

Revo Biologics

Sandoz

Sanofi Pasteur

Shire Pharmaceuticals

SiO2 Medical Products

Takeda Pharmaceuticals

Teva Pharmaceuticals North America

United Therapeutics

WHY NOW?

24+ Countries have already or are planning on implementing serialization regulations! (1)

(1) http://www.delivered.dhl.com/en/articles/2015/05/serialization-a-global-challenge-for-pharmaceutical-supply-chains.html

488 Days until the November 27th, 2017 DSCSA Deadline!

2651 Days until the November 27th, 2023 DSCSA Deadline!

4THPHARMACEUTICAL


PROGRAM HIGHLIGHTS

Take a Peek at our Exclusive Crossover Sessions with the 2nd

Pharmaceutical Packaging & Labeling Forum on Thursday, December 1st!

9:00am: Next-Gen Serialization, the Incorporation of Pharmaceutical Labeling and Artwork into Serialized Data

Session Leader: Scott Mooney Vice President of Distribution Operations McKesson

9:45am: Understanding the Global Scope of Serialization Requirements for Packaging & Labeling

Session Leader: John Woodburn Global Serialization Solution Lead Sanofi

11:15am: Creating a Standardized Packaging and Labeling Process to Meet Wholesaler Requirements

Session Leader: Matt Sample Senior Director, Secure Supply Chain Amerisource Bergen

12:00pm: “The New Normal”- Proactively Addressing Change & Knowledge Management Issues on your Packaging & Labeling Lines in a Post-Serialized Environment

Session Leader: Dr. Jeanne M. Sirovatka, Ph.D, MBB Director, Continuous Improvement Fresenius Kabi USA, LLC

MANUFACTURERS• Assess your internal master

data repositories to ensure data security for the required storage period

• Create a standardized plan for seamlessly handling drop-ship issues with dispensers

• Leverage EPCIS and ERP networks as part of your global strategy and account for upcoming revisions

• Understand the full scope of data requirements for the various international regions where your products will be shipped

DISPENSERS• Understand the “end-of-life”

event for serial numbers and when to decommission them

• Outline your system capabilities to determine where you must invest in order to seamlessly accept serialized data

• Cooperate with your upstream partners to synchronize databases and test exchanges prior to 2023

• Determine whether to store serial numbers past the last point of dispensing and plan accordingly

WHOLESALE DISTRIBUTORS• Define the guidelines for

generating serial numbers for an aggregated product and what to do with customers who have chosen not to aggregate

• Evaluate your ability to retrieve transaction data in order to ensure returns are legally saleable

• Prepare for dealing with product exceptions and encountering other non-serialized products

• Pin-point the weak links in your supply chain both up and downstream prior to 2023 to ensure minimum unforeseen issues

(1) www.tracelink.com/resources/infographic-dscsa-gps

(2) www.pharmamanufacturing.com/articles/2015/serialization-drug-quality-security-act/?start=0

(3) www.supplychainbrain.com/content/technology-solutions/all-technology/single-article-page/article/three-emerging-trends-in-life-sciences-supply-chain-and-serialization/

Thought to Consider: Collaboration is key! Work with supply chain partners to define how the industry as a whole can use this serialized data exchange to achieve cost savings, and more importantly, to better connect with patients.

OVER 5.2 BILLIONserial number events occur annually (1)

Serialized data must be stored for

6 YEARS (1)

Within a distribution network, products change hands up as many as

10 TIMES.(2)

In a 12 year steady state, serialized data repositories will be

7.815 TERABYTES.(3)

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An Industry-Wide Effort- Mastering the Serialized Data Transfer Challenges between

Supply Chain Partners


7:30 Registration & Coffee

8:30 Chairperson’s Welcome and Opening Remarks

8:45 KEYNOTE PANEL DISCUSSION: Exploring the Top Wholesalers’ Outlook on Saleable Returns & Aggregation• Examine the outcome of the HDA pilot on saleable returns and how it will affect

requirements• Prepare for the challenge of being able to retrieve transaction data to make these

returns legally saleable • Understand how aggregating products will aide the saleable return process• How does not aggregating affect trading partners’ interaction and services?

Panelists: Matt Sample Senior Director, Secure Supply Chain Amerisource Bergen

Quentin Dittman Director, Operations Technology and Track and Trace Cardinal Health

Kevan MacKenzie Director, Serialization Technology McKesson

Stat to Consider: 2-3% of all pharmaceutical products shipped will be returned (1)

9:30 Update on the EU Falsified Medicines Directive and Implementing the European Medicines Verification System • Learn about the latest legal updates of the Delegated Regulation complementing the

Falsified Medicines Directive• Stakeholders should align and establish national non-profit organisation to set up

national verification systems• EMVO is offering a blueprint model to support the national stakeholders• EMVO has developed a cost allocation model to share the burden of paying for the

verification system

Maarten Van Baelen Market Access Director Medicines for Europe

10:15 MORNING NETWORKING BREAK & TECHNOLOGY DEMO DRIVE

Take the time to learn about the latest and most innovative technologies available in the industry. These presentations will showcase participating sponsor technologies & services. Attendees will be given a map of the Exhibitor booths running a live demo of their products.

11:00 PANEL DISCUSSION: Tackling the Global Interoperable Data Transfer Between Supply Chain Stakeholders • Discuss how to achieve synchronization of databases throughout the supply

chain and with global suppliers• Review pilot programs aimed to test the potential challenges the 2023 deadline

will bring about• Manage the “drop-ship” issues seamlessly through proper data integration• Leverage EPCIS and ERP networks as part of your global strategy• Understand the “end-of-life” event for serial numbers and when to

decommission them• Maintain data security in your repositories through creating unique serial

numbers to deter hackers

Panelist: Brian Files Director, Pharmacy Inventory Management CVS Health

David Mason Global Program Serialization Lead Sandoz

11:45 Examining Serialization as a 21st Century Approach to Anti-Counterfeiting• Understand the “why” behind your track & trace efforts beyond just meeting

deadlines• Explore innovative solutions to create value from your costly investment into

serialization • Create an implementation strategy that is not just a blueprint copy of others but

that is unique to your organization• Discuss patient safety initiatives past serialization in order to educate customers

of the dangers of counterfeiting

Ben Locwin, Ph.D, MBA Director of Business Strategy, Operations, and Performance/ President Biogen/ Healthcare Science Advisors

MAIN CONFERENCE DAY ONE Wednesday November 30th, 2016

(1) http://pharmaceuticalcommerce.com/special-report/improving-efficiency-effectiveness-of-drug-recalls/

“Opportunity to hear from a vast group of people/companies involved in serialization industry.” - Eli Lilly and Company


12:30 Networking Lunch Break Enjoy lunch while continuing to network with industry peers!

1:30 CASE STUDY: Fast-tracking Contract Partner Serialization Plans to Meet 2017 Deadline• Collaborate with your contract manufacturing partners to insure your products are ready for

serialization• Communicate your specific serialization requirements and standards clearly with partners• Test processes early and often to identify areas for improvement and further coordination• Conduct qualification testing in order to streamline the transition of products to serialized operations

Christopher Howell Senior Director, Global Engineering & Technology Patheon Inc.

2:15 Exploring an Industry-Wide Approach to Saleable Returns and Applicability to 2023 Interoperability • Evaluate the characteristics of an approach for verifying saleable returns that can be readily

adopted by the industry• Assess potential data structures based on those characteristics• Propose an approach that can satisfy both the 2019 saleable returns and 2023 interoperability

requirements• Discuss the unique opportunity that DSCSA presents for the industry to protect this vital

supply chain

Brian Tarantino Director, Serialization Strategy Merck

4:15 INTERACTIVE COUNTRY SPECIFIC DISCUSSIONS Join your peers as we navigate around the challenging international regulations through interactive sessions lead by industry leaders. Bring your questions in advance and be

prepared to join the conversation!

3:00 Join your peers to continue the discussion while networking over refreshments.

3:30 Industry Update on GS1 US Implementation Guide 1.2 for Serialization• Review the updates and enhancements in the newly published Implementation Guide 1.2• Utilize and understand the benefits of using GS1 EPCIS and CBV standards for electronic

commerce• Begin to look beyond the 2017 deadlines and focus on initiatives for 2019, 2023, and

beyond• Advice for smaller and medium sized manufacturers who are behind on DSCSA implementation• What is next? Discuss upcoming industry pilot programs, testing, and possible FDA guidances

Peter Sturtevant Sr. Director Industry Development GS1US

4:40 BRAZIL Strategize your Serialization Plans to Account for a Changing International Landscape• Recent regulation updates in each region• Specific packaging & labeling requirements in each region• Predict future changes in existing deadlines• Data transfer challenges to each market• Prepare for shipment delays to region’s with stricter guidance’s in place• Understand the diversity of compliance information requirements for you and your network• Discuss the key factors that need to be present to ensure a consistent global supply

4:55 RUSSIA

5:20 MIDDLE EASTDiscussion Leader: Brian Tarantino, Director, Serialization Strategy, Merck

5:45 INDIA

6:10 End of Main Conference Day One: NETWORKING DRINKS RECEPTION IN EXHIBIT HALL After a long day of intense learning, join your colleagues for some drinks and create valuable discussions and connections.

“Very good discussion panels and presentations. Good overall review from manufacturing through to supply.”

-GlaxoSmithKline

MAIN CONFERENCE DAY ONE continued


7:30 Registration & Coffee

8:45 Chairperson’s Welcome and Opening Remarks

9:00 KEYNOTE: Next-Gen Serialization, The Incorporation of Pharmaceutical Labeling and Artwork into Serialized Data• Embed required information into serialization• Find new ways to use serialization to the benefit of packaging, labeling, and artwork

teams• Maximize the efficiency of internal track and trace technology• Adopt best practices handling new, overlapping tasks between packaging, labeling,

artwork, and serialization

Scott Mooney Vice President of Distribution Operations McKesson

9:45 Understanding the Global Scope of Serialization Requirements for Packaging & Labeling • Discuss the benefits of using EU required tamper-evident packaging in other markets• Allow for extra time and man power when running lines for shipments to China and

other countries with more stringent data requirements• Prepare for changes coming out of regions such as Brazil, China, and Russia and make

adjustments ahead of time• Understand the implications of the DGFT requirement conflicting with the DSCSA and

other countries

John Woodburn Global Serialization Solution Lead Sanofi

10:30 MORNING NETWORKING BREAK & TECHNOLOGY DEMO DRIVE

Take the time to learn about the latest and most innovative technologies available in the industry.

11:15 Creating a Standardized Packaging and Labeling Process to Meet Wholesaler Requirements• Define your supply chain partners’ guidelines on aggregation and adjust your processes

to meet those needs• Understand why all serialized labeling is not created equal and the preferred choices of

supply chain partners • Create one standard for labeling, and understand what “bad” labeling will mean come

2017 and beyond• Examine the current state challenges with pharmaceutical packaging, specifically HDA

Guidelines and GS1 standards

Matt Sample Senior Director, Secure Supply Chain Amerisource Bergen

12:00 “The New Normal”- Proactively Addressing Change & Knowledge Management Issues on your Packaging & Labeling Lines in a Post-Serialized Environment• Determine a schedule for training line-level team members on serialization to reduce

uncertainty after implementation• Proactively prepare your downstream warehouse teams for implementation• Ensure your teams are well-versed in the new technology being implemented for

serialization• Strategize where you will Integrate your vendor partners into your training based on areas

of need • Streamline communications by creating a standardized terminology for vendors and

internal teams to adhere to post-implementation

Dr. Jeanne M. Sirovatka, Ph.D, MBB Director, Continuous Improvement Fresenius Kabi USA, LLC

12:45 Join Us for a Networking Lunch Break to Grow your Industry Network and Continue Discussing the Hot Topics

Our first four sessions of the day, highlighted below, will be co-located with our Packaging & Labeling Forum! Please take advantage of this exclusive opportunity to hear the latest industry updates in packaging & labeling for serialization and network with a new group of peers.

MAIN CONFERENCE DAY TWO Thursday December 1st, 2016

“All the major players from across the supply chain were present greatly enhancing discussion and learning. -Fresenius Kabi


1:45 Thinking Beyond Compliance: Overcoming Serialization Plant Floor Interoperability Challenges to Achieve a Connected Enterprise & Realize Business ROI Benefits• Review the three main challenges to creating an interoperable serialization ePedigree

system with your Connected Enterprise• Understand the key areas where your business can be optimized once connected with

real time visibility to your customers• Examine serialization as a subset of a larger connected enterprise where digitization and

data analytics can be utilized for better business decisions• Begin to think beyond deadlines and what you must do, and instead about what you can

do to improve product quality & product services

Joe Whyte Director Serialization & Connected Enterprise Solutions Rockwell Automation

2:30 PANEL DISCUSSION: An In-Depth Discussion on Dispenser Challenges Surrounding DSCSA Deadlines• Decide whether to store serial numbers past the last point of dispensing• Discuss potential issues that will arise past the 2020 DSCSA Deadline and how upstream

partners can help• Control issues for saleable returns to wholesalers through serialization • Prepare for challenging drop-ships with manufacturers by establishing a system for data

transfer• Review opportunities that will emerge for dispensers beyond compliance• Understand the challenges for getting products direct from manufacturers as opposed to

through wholesalers

Panelist: Brian Files Director, Pharmacy Inventory Management CVS Health

Chris Smith Director of Federal Public Policy National Association of Chain Drug Stores (NACDS)

3:15 Join your peers to continue the discussion while networking over refreshments.

3:40 CASE STUDY: Examining the Challenges when Implementing Serialization for a Non-serialized Driven Operation• Determine your corporate philosophy for serialization and communicate it clearly with

your teams• Avoid diversion during implementation while maintaining flexibility of shared resources • Prepare precise timelines and test your lines in advance in order to avoid an entire site

shutdown• Decide the exact volume and percentage within your varied product lines where

serialization would apply

Scott Hall Director Package Engineer & Product B. Braun Medical Health

Damian Rodriguez Package Engineering Specialist B. Braun Medical Health

4:25 INTERACTIVE ROUNDTABLES: Tackling the Root Issues of your Serialization Initiatives

Please choose the table that fits best with your current challenges regarding serialization. Use this time to bring the knowledge you have gathered over the last couple days to the group in order to come up with innovative solutions together.

MAIN CONFERENCE DAY TWO continued

Interactive Roundtables

Table 1: Data Storage & Transfer Challenges• Discuss best practices for handling drop-ships between manufacturing and dispensers• Analyze recent pilot programs aimed to test interoperability by 2023• Review the end-of-life event for serial numbers and if it is up to the dispensers to

decommission• Understand methods for ensuring data security in your repositories and the optimum

amount of time to hold and release serial numbers

Table 2: Packaging & Labeling and Line-Level Challenges• Review change management issues that will occur when adopting a new system for

serialization at the line level• Determine when to use automated or manual lines for specific products• Exchange best practices for minimizing down-times when upgrading your lines for

serialization• Examine new technologies in labeling that are making serial numbers more difficult for

counterfeiters to duplicate

Table 3: Initial Implementation and Testing Challenges• Learn the best practices directly from your peers for starting your budgeting and

planning of implementation• Choosing the right internal team to put in place to take care of serialization through to

the end• How to pick the right vendors for your particular needs and unique product lines• Discuss the benefits and drawbacks and deciding to outsource• Discover the major costs are your peers incurring and how to adjust your own budgets

5:10 End of Main Conference Day Two

“Great information and highlight of unanswered questions to consider for our strategy.” - Life Science Logistics


8:00am Registration Workshop A

8:30am WORKSHOP A: Fine-Tuning your Strategic Game Plan to Ensure Contract Partner Readiness by 2017

With outsourced pharmaceutical manufacturing operations estimated to be at about 40% of all product lines, the emphasis on CMO readiness for serialization deadlines is higher than ever before. Experts anticipate that CMO market value will exceed $60 billion by 2018. CMO’s are currently struggling to keep pace with serializing their current product lines and will have even more trouble if more SKUs are added to their portfolios. It is up to the contract organizations’ internal teams to choose their solutions providers and get started. Yet with so many of their products on the line, pharma manufacturers are keeping a close eye on their partners’ progress.

What you will learn:

• Evaluate all your contract partners’ readiness to decide where to begin giving resources

• Create a detailed on-boarding schedule for all CMO/CPO’s that ensures deadlines are met

• Prepare for the chance that not all partners will be ready and you may have to allocate product lines elsewhere

• Standardize serial number generation procedures and serialized product event exchanges to reduce costly mistakes

• Decide what international regulations will affect your contract partners and make sure they are in compliance

10:30am Registration Workshop B – Lunch will be served during this workshop

10:45am WORKSHOP B: To Aggregate or Not to Aggregate? Determining the Best Plan for your Organization

Aggregation is quickly becoming the elephant in the room of most discussions around serialization. It not required in the US, but may be required by wholesalers by 2023. Whether your organization is deciding to aggregate now or waiting for downstream partners to force their hand, it is wise to know your options in detail. Aggregation requires more solutions, more manpower, and more data storage & transfer capabilities. It is extra effort on top of an already grueling serialization process. But if patient safety is really the end goal, it is something that may be worth the effort.

What will you learn:

• Understand the true value of aggregation and how it is the logical next step to serialization

• Review the impact aggregation has on all levels of the supply chain, specifically saleable returns to wholesalers

• Discuss the need to aggregate on outbound orders in addition to packaging lines

• Evaluate all product lines to determine where it makes sense to begin aggregation

• Prepare ahead for challenges if you are choosing not to aggregate

• Determine a plan to handle the discrepancy with supply chain partners who are not aggregating, or aggregating at a later date

Workshop Leader: Kevan MacKenzie Director, Serialization Technology McKesson

POST-CONFERENCE WORKSHOP DAY Friday December 2nd, 2016

“Speakers discussing topics that are current and relevant to serialization. Speakers were very knowledgeable

on topics they were presenting.” - Apotex Corporation


1:00pm Registration Workshop C

1:15pm WORKSHOP C: Streamlining Data Transfers & Maintaining Visibility Throughout the Supply Chain

Serialization is quickly creating a big data problem for the pharma industry. Aside from storing your serialization data in internal repositories, you must be able to transfer that data to supply chain partners and make it highly visible throughout its trips both down and back upstream. With incompatible systems and varied DSCSA deadlines, this is a major challenge. The 2023 deadline is one that the supply chain as a whole will have to reach together. Through clear communication of requirements and proactive decision making, this fully interoperable system is achievable.


• How to deal with “drop-ship” issues when trading data with indirect partners

• Examine the global spectrum of data requirements when transferring serial number events

• Determine the weak links in your supply chain to mitigate data transfer issues ahead of time

• How can we use this data to better patient safety past the 2023 deadline?

• Review the new EPCIS standards coming out in 2016 and its effect on your operations

• Understand exceptions to standard procedures when sharing data with partners

3:15pm Registration Workshop D

3:30pm WORKSHOP D: Looking Past Deadlines- Optimize Implementation to Generate Value through Serialization

Serialization is a time-consuming, costly expense for pharmaceutical companies and biotech’s both big and small. Companies are not looking to invest money to simply just comply to the law, but instead the industry is looking to gain incremental value from this investment. Organizations that adopt this big picture way of thinking early will be the ones who gain the most value and set themselves ahead of the pack. Serialization can be used to interact with the consumer in ways unachievable before. Also product traceability sets a new standard of safety that brands will strive to adhere to in order to ensure customer loyalty.


• Understand how maximize your limited resources and manpower during initial implementation

• Avoid additional investments in the future by leveraging and expanding on what you have in place now

• Utilize the new technologies available to future-proof your plans

• Create new channels of communication with your customers through serialization

• Learn from companies who have already utilized serialization to their advantage by positioning their brand better to consumers

• Discuss how even the smallest teams can set plans in place to achieve incremental value through serialization efforts

Workshop Leader: Mike Wallace Former Director, Global Standards & Serialization Abbott Laboratories

5:30pm End of Workshop Day

STAY CONNECTED! Keep the conversation going and stay in touch with industry peers through our LinkedIn group: Pharmaceutical Traceability & Serialization

POST-CONFERENCE WORKSHOP DAY continued


MEET OUR SPONSORS!

Atlantic Zeiser www.atlanticzeiser.com

Atlantic Zeiser is a leading provider of sophisticated individualization, serialization and track & trace solutions. Atlantic Zeiser’s MEDTRACKER is a modular software solution that has been designed for serialization and Track & Trace applications and allows the administration of multiple lines or sites at the same time.

Rockwell Automation www.rockwellautomation.com/global/about-us/company-overview.page

Rockwell Automation Inc. (NYSE: ROK), the world’s largest company dedicated to industrial automation and information, makes its customers more productive and the world more sustainable. Headquartered in Milwaukee, Wis., Rockwell Automation employs over 22,000 people serving customers in more than 80 countries.

SAPhttp://go.sap.com/documents/2016/07/0a4e1b8c-7e7c-0010-82c7-eda71af511fa.html

SAP is the world leader in enterprise applications in terms of software and software-related service revenue. Based on market capitalization, we are the world’s third largest independent software manufacturer From pioneering ERP software to new offerings like the SAP HANA in-memory computing platform, SAP innovation goes beyond software – we’re developing breakthrough technologies that shape IT and business trends.

Thanks to Our Media Partners:


PRICING & REGISTRATIONwww.PharmaceuticalTraceabilityForum.com

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All Access: Main Conference + All 4 Workshops $3,599 (SAVE $100) $3,699

One Workshop $549

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Solution providers have an excellent opportunity to showcase their products and services to senior level, targeted executives attending Pharma IQ’s Pharmaceutical Traceability Forum. IQPC and Pharma IQ help companies like yours achieve important sales, marketing and branding objectives by setting aside a limited number of event opportunities – all of which are tailored to assist your organization in creating a platform to maximize its exposure at the event.

Interested in sponsoring the forum? Reach out to Chris Ritchie at [email protected] or 212-885-2799

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november 30th - december 2nd, 2016 pharmaceutical ... · abbott laboratories director, pharmacy...

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