The World's Largest Global Forum for Cold
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Table of Contents:
    6 Annual Global Forum
        th

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Who will attend:




Seniority                                            Function                                        ...
121 different companies attended Cold Chain Distribution 2007
      Acambis                                               ...
Main Conference Day One
Tuesday, September 23, 2008

       Breakfast & Registration                                      ...
Day One continued...


            The Building Blocks of ePedigree Compliance:                                           ...
Main Conference Day Two
Wednesday, September 24, 2008
        Breakfast & Registration                                    ...
Day Two continued...

                                                                           Concurrent Tracks
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Pre-Conference Workshops
                              Monday, September 22, 2008
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2:30 pm – 5:30 pm                 Registration 2:15
                                E          Critical Designing, Evaluat...
6th Annual Cold Chain Distribution for Pharmaceuticals
6th Annual Cold Chain Distribution for Pharmaceuticals
6th Annual Cold Chain Distribution for Pharmaceuticals
6th Annual Cold Chain Distribution for Pharmaceuticals
6th Annual Cold Chain Distribution for Pharmaceuticals
6th Annual Cold Chain Distribution for Pharmaceuticals
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6th Annual Cold Chain Distribution for Pharmaceuticals

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The 6th Annual Cold Chain Distribution for Pharmaceuticals conference (September 2008 in Philadelphia, PA). The world's largest supply chain conference for temperature-sensitive pharmacueticals.

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6th Annual Cold Chain Distribution for Pharmaceuticals

  1. 1. The World's Largest Global Forum for Cold Register by 7/11/08 Chain Specialists - Sold Out in the US, UK, SAVE $400 Belgium, Brazil, Singapore and Germany and 6 th Annual Global Forum Cold Chain Distribution for Pharmaceuticals TM Gain International Gaining Greater Control of Your Global Cold Chain Insights from: and Ensuring International Regulatory Compliance Rafik H. Bishara, PhD Technical Advisor and Chair Pharmaceutical Cold Chain Interest Group (PCCIG) USA Branch, PDA Ian Holloway September 22-25, 2008 Manager, Defective Medicines Report Centre Philadelphia Convention Center • Philadelphia, PA MHRA Gwyn Murdoch Manager, Distribution Quality Compliance Eli Lilly BRAND NEW! Harold Rode Chief, Pandemic Influenza Division, Only at Cold Chain Distribution 2008 Will You Benefit from: Biologics and Genetic Therapies Directorate Health Canada Discussions on ePedigree Compliance & the impact of the • Dr Mary Foster imminent state and FDA deadlines USP Packaging and Storage Expert Committee Member Views & guidance from 6 International Regulatory Agencies US Pharmacopeia (USP) • including: MHRA, Health Canada, USP, GS1, PCCIG and U.S. Customs Nathan Habeck ePedigree Initiative Program Manager A choice of 11 workshops relevant to your evolving Cold Chain • Baxter Healthcare Brad Elrod A look at managing an international Cold Chain & expanding into • Manager, Global Logistics & Security emerging markets Pfizer 1 intensive Master Class on “Re-Engineering the Cold Chain” by Geoffrey Glauser • Director Cold Chain Technology, Biotech Sanofi Pasteur Technology & Engineering - Drug Product, Wyeth Pharmaceuticals 4 newly focused tracks on Cold Clinical Supplies, ePedigree & • Allen Napetian Packaging, Qualifying Your Cold Chain, and Supply Chain and the Drug Product Finishing Associate Director, ‘Last Miles’ Genentech Sponsors: Register Today: Call 1-800-882-8684 • www.coldchainpharma.com
  2. 2. Table of Contents: 6 Annual Global Forum th Regulatory Expectations Cold Chain Distribution Plenary Sessions . . . . . . . . . . . . .5 for Pharmaceuticals ePedigree and TM Packaging Track . . . . . . . . . . .5-6 Cold Clinical Supply Operations Track . . . . . . . . . . .5-6 Dear Colleague, Networking Roundtable It’s been a pleasure speaking with many of you during the planning of this year’s Cold Chain Distribution Discussions . . . . . . . . . . . . . . . . .6 for Pharmaceutical conference program. The positive feedback to the annual industry gathering in Philadelphia has been encouraging and a fantastic foundation for the 2008 event! International Cold Chain Plenary Sessions . . . . . . . . . . . . .7 The 6th Annual Global Forum is the largest, most comprehensive temperature control forum for biopharmaceutical professionals, with 300+ peers in Supply Chain, Distribution, QA, Regulatory, Qualifying Your Transportation, Packaging and Security attending this event each year. Cold Chain Track . . . . . . . . . .7-8 All new, for you – Cold Chain Distribution for Pharmaceuticals 2008! Supply Chain Management To bring fresh and innovative content to the 2008 program, we’ve been consulting with you and your & ‘Last Miles’ Track . . . . . . . .7-8 industry peers to understand the critical issues facing the industry right now and for the future. Pre / Mid New 2008 sessions include: Conference Workshop Programs . . . . . . . . . . . . . . .9-11 Planning International Supply Chains & Overcoming Custom Challenges – With a Close Look at India and • Other Emerging Markets Sanofi-Pasteur Improving Supply Chain Visibility by Implementing Mass Serialization & Updating Your ePedigree • Master Class Agenda . . . . . . . .12 Compliance Understanding What it Takes to Control Products During the quot;Last Milesquot; About Sponsors • Standardizing Packaging Validation & Using Green Packaging • and Exhibitors . . . . . . . . . .13-14 Meeting International Regulations for the Cold Chain • Overcoming the Specific Challenges to Cold Clinical Supplies for International Trials Pricing and Registration • Implementing Process Improvement Opportunities to Minimize Temperature Deviations and Streamline • Information . . . . . . . . . . . . . . .15 End-to-End Operations Plus don’t miss this annual opportunity to discuss regulatory expectations and industry best practices with key international leaders and industry partners speaking at Cold Chain Distribution 2008, including: Health Canada… are you conducting the right validation studies for -20°F? • Medicines Healthcare Regulatory Agency (MHRA)… getting cold clinical supplies right • U.S. Customs and Border Control… avoiding custom delays during international trade • United States Pharmacopeia (USP)… implementing the final <1079> Chapter • PLUS – GS1… taking direction for industry best practice mass serialization and ePedigree • PCCIG…industry best practices for today’s cold chain • …plus numerous industry case studies • Maximize your time out Don’t miss the chance to attend the year’s premier cold chain event. It’s the ideal networking of the office by opportunity to meet with regulators, academia, top industry leaders and partners of cold chain solutions. attending the post- The speakers, sponsors and Pharma IQ team look forward to seeing you in September in Philadelphia for conference full-day the Cold Chain Distribution for Pharmaceuticals 2008 conference. Master Class Sincerely, ‘Re-Engineering Your Cold Chain nity to t PS: Don t miss your oppolrtucritical ge l Courtney Becker-James Management’, led by up-to-speed with TODAY S e pre / Conference Director Pharma IQ, a division of IQPC Sanofi-Pasteur. (See tiv issues during the interacs. Choose from www.coldchainpharma.com mid conference workshop page 12 for the agenda.) courtney.becker@iqpc.co.uk 11 new workshops! Register Today: Call 1-800-882-8684 • www.coldchainpharma.com 2
  3. 3. Who will attend: Seniority Function Industry ■ ■ ■ 64% 42% Manager 21% Global/Regional Supply Chain Biopharmaceutical Manufacturer ■ ■ 26% Director 18% QA and Validation ■ 13% Technology Providers ■ ■ 10% President 14 % Logistics/Distribution/Transport ■ 10% Medical Device and ■ ■ 9% Specialist 12% Clinical Trial Supply Diagnostic ■ ■ 6% Vice President 10% Packaging Engineer ■ 9% Transport Providers ■ ■ 6% Team Leader/Supervisor 8% Regulatory Affairs and Compliance ■ 5% Government Officials ■ ■ 1% CEO 7% Marketing and Sales ■ 1% Nutraceuticals ■ 6% Materials Management ■ 2% Cold Chain Management ■ 1% Supply Sourcing ■ 1% Customer Service Pre-Conference Workshops • Monday, September 22, 2008 Choose from Workshop A or B B 8:00 am – 11:00 am Breakfast will be served 8:00 am – 11:00 am Breakfast will be served A Quality by Design – What it Means to the Cold Chain Master Course for Today’s Packaging Engineers George Flora, President, Minnesota Thermal Science Neritan Mustafa, Life Sciences Program Manager, Sensitech Choose from Workshop C or D C D 11:15 am – 2:15 pm Lunch will be served 11:15 am – 2:15 pm Lunch will be served Outsourcing Your Cold Chain Project Management: Revelations in Heat Transfer Opportunities & Strategies for Success Rob Abramovitch, General Manager, Insulation, Polyair Robert (Bob) Bohne, VP, General Manager, Cold Chain Technologies Brian Martin, VP, Consumer Markets North America, Polyair Jeff Simpson, Director of Engineering & Technical Services, Cold Rudy Ponce, Sr. Director of Marketing, Polyair Chain Technologies Anthony Rizzo, Project Manager, Cold Chain Technologies Jim Nilsen, Project Manager, Cold Chain Technologies Choose from Workshop E or F E F 2:30 pm – 5:30 pm 2:30 pm – 5:30 pm Critical Designing, Evaluating and Testing Best Practices in Temperature-Controlled Temperature Sensitive Product Packaging Transportation Anthony Alleva, Project Engineer & Mike Paterno, Project Karl Kussow, Manager Quality and Validation, FedEx Custom Manager, TCP Reliable Critical Choose from Workshop G or H G H 5:45 pm – 8:45 pm Dinner will be served 5:45 pm – 8:45 pm Dinner will be served How to Meet GMP and GDP Regulations Using Temperature Mapping, Supply Chain Planning and Temperature Monitoring Solutions Speciality Logistics for International Clinical Trials Martina Brennan, National Sales Manager, ColdTRAK Tony Mistretta, Distribution Manager, ALMAC GROUP Charles Craig, Validation and Technical Engineer, DeltaTRAK Mid-Conference Workshops • Tuesday, September 23, 2008 Choose from Workshop I or J or K I J 6:45 pm – 9:00 pm Dinner will be served 6:45 pm – 9:00 pm Dinner will be served Reusable Packaging in the Cold Chain Industry Best Practice Trailer Thermal Mapping According to Technical Report 39 Dr. John Pring, CEO, Control Quality Systems Chris Pollard, CEO, KryoTrans International Ltd. Kathy Denholm, Director, Life Sciences & Pharmaceutical Industry, Panther Expedited Services, Inc. K 6:45 pm – 9:00 pm Dinner will be served Security Challenges and Tools for the Cold Chain Phil Viggiani, V.P. Sales & Marketing, IDGLOBAL Corp. 3
  4. 4. 121 different companies attended Cold Chain Distribution 2007 Acambis Kodiak Thermal Technologies Accredo Health - Medco KryoTrans International Very good speakers Agensys Inc. Kuehne & Nagel, Inc. Air Canada Cargo Laminar Medica Alexion Pharmaceuticals LifeConEx LLC and subject matter Almac Group Madgetech Inc Althea MannKind Corporation and was filled with AmerisourceBergen Corp. McKesson Canada Amylin Pharmaceuticals Inc Medco Health Services Anchorage Economic Development Medtronic Spinal & Biologics information rather Corporation Merck & Co. Inc. Andlauder Transportation Services Merial Anesiva Inc than basic concepts. MGI Pharama Arteragen MicroDAQ.com,Ltd ATS Andlauer Transportation Services Midnite Express Auxilium Pharmaceuticals Incorporated - Logistics Project Minnesota Thermal Science Baxter Healthcare Mirsalcom Transport & Delivery Services LLC Baxter Pharmaceutical Solutions Motorola Inc. Manager, Bilcare Inc. Bilcare Inc Nadro BioCair, Inc. Nanocool Biogen Idec Neose Technologies BioMerieux Inc Novartis Animal Health Us Inc Boston Scientific Packaging Products Corp Bristol Meyers Squibb Paddock Laboratories Inc. Very informative! Burris Logistics PANTHER Expedited Services Calea Ltd. PDL BioPharma Cardinal Health Pfizer Inc. - Stability Project Cavalier Logistics PharmaCare Specialty Pharmacy Celgene Pharmaceutical Partners of Canada Centeror Plastilite Corp Analyst, Merck & Co Charles River Laboratories Inc. Polyair Cold Chain Technologies Rand Whitney Container Covidien Health Care RatioPharm CSL Behring Remel Inc Dallas Semiconductor Corp Rite Aid Dayton Roche Diagnostics Operations Inc Information was Defense Supply Center Philadelphia Roche Molecular Systems Dendreon Corp Sanofi Pasteur Dentsply Pharmaceutical very valuable Schering Plough Corporation Discovery Labs. Schwarz Biosciences Eli Lilly Sealed Air Corp. Elpro Services – Director, Global Sensitech Envirotainer Sepracor Ernest Paper Products Shire Human Genetic Therapies Logistics, Bilcare Inc. Escort Data Loggers Inc Talecris Biotherapeutics Inc. Expeditors - Healthcare Industry Group TCP Reliable Inc Express Scripts Tegrant Thermosafe Brands FedEx Custom Critical Temp Time Corp Fisher Bio Services Tempcell Fisher Clinical Service Inc Tunnell Consulting Excellent info and Frontier Paper UPS Customer Solutions Gen Probe US Pharmacopeia Genetech Valsource Inc. great presentations Genzyme Corporation Walgreens- Medmark Inc Great Point Partners Watson Pharmaceuticals Green Capital Consulting LLC World Courier – Packaging Engineer, Health Canada Drug Distribution Center Wyeth Biotech Hospira Healthcare Corp Wyeth Pharmaceuticals Remel Immunogen Inc Wyeth Research Iris Diagnostics Inc. Xanodyne Pharmaceuticals Inc J&J Centocor ZLB Plasma Johnson and Johnson Sales and Logistics Co. LLC Register Today: Call 1-800-882-8684 • www.coldchainpharma.com 4
  5. 5. Main Conference Day One Tuesday, September 23, 2008 Breakfast & Registration Morning Networking & Refreshment Break 7:00 9:45 Pharma IQ Welcome 7:45 The Final Updated Revisions to General 10:30 Chapter 1079: Practical Guidance to Updating Opening Remarks from the Chairperson 7:50 Your Cold Chain Management Rafik H. Bishara, PhD, Technical Advisor and Chair Explaining recommended control strategies – from warehouse • Pharmaceutical Cold Chain Interest Group (PCCIG) USA Branch, through end-user PDA • Describing specific protocols for receiving, shipping and storing – when, how and how much MHRA Regulatory Feedback - Ensuring Your 8:00 • Following the tables in the updated guidance to make the Products Comply With European Temperature right choices in your cold chain management Control Regulations From Clinical Materials to • Understanding the updated SOPs and how to implement them Marketed Products Dr Mary Foster, USP Packaging and Storage Expert Committee Comparing MHRA regulations with other European National • Member, US Pharmacopeia (USP) Agencies – Are U.S. companies on the right track to comply across Europe? Panel Discussion: Understanding Current and • Gaining a European regulatory view on how industries can 11:15 gain more control of temperature-sensitive products further Future Regulatory Expectations for the Cold downstream in the cold chain Chain • Clinical materials – What are the Regulators concerns and Reviewing global regulatory concerns • expectations? Understanding the impact of outsourcing manufacturing on • • Describing what information and how much should be the cold chain included in quality reports and risk assessments Controlling and working with Controlled Room Temperatures • Ian Holloway, Manager, Defective Medicines Report Centre, Ian Holloway, Manager, Defective Medicines Report Centre, MHRA MHRA Meeting Canadian Regulatory and Inspection 9:00 Harold Rode, Chief, Pandemic Influenza Division, Biologics and Genetic Therapies Directorate, Health Canada Requirements for Temperature Sensitive Products Dr Mary Foster, USP Packaging and Storage Expert Committee Understanding the feedback from recent audits on how to Member, US Pharmacopeia (USP) • show evidence of compliance: Are you conducting the right Rafik H. Bishara, PhD, Technical Advisor and Chair validation studies for -20°F? Pharmaceutical Cold Chain Interest Group (PCCIG) USA Branch, • Describing stability studies and data that work PDA • Recognizing how manufacturers can assist the Canadian Provinces when there is a cold chain breach Lunch and Networking for Speakers & 12:15 Harold Rode, Chief, Pandemic Influenza Division, Biologics and Delegates Genetic Therapies Directorate, Health Canada Concurrent Tracks Track B – Cold Chain Supply Operations Track A – ePedigree & Packaging Gearing up for International Harmonization of Case Study – Managing Temperature Sensitive 1:15 1:15 Serialization and RFID Data and Practices in Clinical Supplies for International Clinical Trials Evaluating the risks of shipping longer distances to specific Healthcare • countries Understanding GS1 recommendations for serialization • Calculating probability for product loss and overage to • • Working toward harmonization of RFID and Bar Code data determine optimal quantities of shipments Providing sensor (temperature) data through the EPCIS standard • • Implementing strategies for each eventuality – custom delays in • Gaining an up-to-date understanding of how industry standards certain countries, various regional temperature profiles and for serialization are working toward compliance of US ePedigree factoring timelines for raw materials laws and deadlines • Defining methods for improved monitoring and temperature Bob Celeste, Director, Healthcare, GS1 US / EPCglobal North mapping of longer distance shipments for clinical trials America • Improving project management aspects of international cold clinical operations C. Ray Goff, Jr., Director, Vaccine R&D, Wyeth Research 5
  6. 6. Day One continued... The Building Blocks of ePedigree Compliance: Transitioning from Clinical Studies to 2:00 2:00 Baxter Healthcare Case Study Launching Commercial Products: Putting the Gearing up for ePedigree compliance amidst legal uncertainties Validation Pieces Together • Key challenges for a pharmaceutical manufacturer – • Undergoing new shipping validation studies with new routes • implementing mass serialization and greater quantities • Handling serialized products in the distribution chain • Implementing new process validation studies – Adapting • Data management, sharing and synchronization stability data and validation information to demonstrate a • Business process improvement challenges, opportunities & regulatory qualified process solutions • Validating new packaging components – Evaluating re-usable Nathan Habeck, ePedigree Initiative Program Manager, options and costs Baxter Healthcare • Forming partnerships with appropriate logistic partners: SOPs, training and monitoring to ensure product integrity • Putting the pieces together considering financial aspects and training new staff Please check www.coldchainpharma.com for speaker updates and opportunities. Discussion Session: Exchanging Best Practices 2:45 Standardization of Package Qualification 2:45 for Temperature Sensitive Multi-National The qualification of insulated packages should be linked to a company-wide master qualification plan that aligns objectives Clinical Supply Operations and scope of a qualification effort and provides guidance on the Clinical Supplies are a whole other animal compared to commercial qualification philosophy and approach to projects. Although products. In this session we will discuss key differences and the individual packout specifics are not contained in a master plan, unique challenges of smaller, more variable clinical shipments Design Qualification, Operational Qualification and Performance including: Qualification should be addressed such that operational • So many different products, shipping requirements and parameters are clearly delineated and incorporated into the shipping lanes: How are companies dealing with such individual package protocols. This session will explore these key variables? issues further: • How is packaging best qualified for longer transit routes? • Aligning qualifications across design, operations and • Evaluating stability studies used for clinical supplies performance measures according to the company’s master plan • Managing excursions for clinical distributions • Defining the technical qualifications of your packaging and • Where is the information held and how is the data used for establishing a numerical value for each global trials? • Setting expectations of using this data as templates to answer • Controlled Room Temperature solutions and strategies questions and solve issues for continuous process Panelists: improvements Tony Mistretta, Distribution Manager, ALMAC GROUP Geoffrey Glauser, Director Cold Chain Technology, Biotech C. Ray Goff, Jr., Director, Vaccine R&D, Wyeth Research Technology & Engineering - Drug Product, Wyeth Pharmaceuticals Afternoon Refreshments 3:30 Networking Roundtable Discussions 4:00 After a full day of presentations, it’s time for all participants to take an active role and get answers to specific questions. Attendees will get a comprehensive review of the surrounding issues, technical capabilities and differing end-user views. Discussion facilitators will present a short case study as a benchmark for a 60-minute discussion and question session. Delegates choose from one of the following parallel sessions: A) ePedigree in the Cold Chain: Exchanging Strategies with E) Measures to Ensure Temperature and Product Compliance? Other Companies to Decide Next Steps Roundtable Leaders: Keith Holland, Distribution Services Manager, Schering Plough B) Process Improvements in Transportation: Using & Kathy Denholm, Director, Life Sciences & Pharmaceutical Your Knowledge, Science and Standards to Streamline Industry, Panther Expedited Services Your Transportation Process Roundtable Leader: Jim Bacon, Director, Global Demand F) What About our Own Sales Reps? How Can we be Sure They Planning & Customer Operations, Talecris Biotherapeutics Are Handling our Valuable Products Correctly? C) FDA Audits: What Are the Transportation Requirements G) Developing Scientifically Sound and Standardized Cold Chain We Have to be Ready For? Packaging Models – How to Build Qualified Containers Roundtable Leader: Geoffrey Glauser, Director, Cold Chain D) Developing and Maintaining a Strategy for Controlled Technology, Wyeth Pharmaceuticals Room Temperature (CRT) Requirements H) Green Packaging and Logistics – Investigating Reusable and Recyclable Solutions to Gain Competitive Advantage and Cut Costs Summary of Roundtable Discussions: Taking Key Lessons from Each Discussion 5:00 All participants will re-convene in the main conference room to hear five minute summaries from discussion leaders to learn the most interesting findings of each discussion. Closing Remarks from Chairperson and End of Day One 5:40 Cocktail Reception and Networking Opportunity 5.45 Join your colleagues from across disciplines to exchange ideas and network in an informal environment. Take this time to learn from the industry’s top technology and logistics providers to update and advance your cold chain management. Register Today: Call 1-800-882-8684 • www.coldchainpharma.com 6
  7. 7. Main Conference Day Two Wednesday, September 24, 2008 Breakfast & Registration Morning Networking & Refreshment Break 7:45 10:45 Opening Remarks from the Chairperson 8:15 Ocean Reefer Case Study: Establishing New 11:15 Ocean Lanes, Cost-Effective, Full Visibility and Keynote Session: Ensuring Valuable Medicines 8:30 Reliable Transport Are Transported Effectively and Safely – How Exploring the business drivers for ocean carriers of temperature • to Avoid Custom Delays in an International sensitive products and bulk material including cost and reliability Trade Market • Examining the results of the first test campaign of current and Understanding what documentation is necessary and when • new ocean reefers Dangerous goods classifications and requirements • • Identifying suitable transport lanes using different types of ocean • Should industry be using specialized carriers for human and reefer blood samples for quicker customs clearance? • Evaluating new tracking and monitoring technologies • Counterfeit drug concerns – how we can work together to • Discussing the drivers and steps for converting air and ground protect consumers shipments to ocean reefer • C-TPAT – A great opportunity to ensure expedited customs Professor Jean-Pierre Emond, Co-Director, Institute of Food clearance and Agricultural Sciences, University of Florida • Common misconceptions to be aware of and advice to industry Panel Discussion: Best Practice International Representative, Port of Philadelphia, US Customs and 12:00 Border Protection Distribution and Logistics of Cold and CRT Products Working and Complying with the New TSA 9:15 Biopharmaceutical companies are increasingly outsourcing Certified Cargo Screening Program to Avoid manufacturing, distribution and speciality logistics operations. Many complex challenges exist in ensuring a safe supply of Costly and Risky Delays temperature sensitive medicines to the patient and regulatory By February 2009, 50% of your air cargo on passenger aircrafts compliance in global markets. In this panel discussion, we will will have to be screened at piece level through the new TSA exchange best practices in gaining more visibility, decreasing screening program. By August 2010, it will be 100%. To risk and working with distribution partners. decrease cargo delays and ensure expedited supply chain flow, • Understanding custom clearance issues in global markets to manufacturers may choose to become certified to do their own avoid transit delays screening, rather than have untrained people break down the • Importation safety into the U.S. – What processes, laws and packaging of high value products at a remote site. This session solutions are we putting in place to monitor drugs coming will provide feedback about collaboration in the TSA pilot to into the U.S.? become certified to screen your own products. Key topics will • Developing a trusted global network of distribution partners include: • Evaluating cold chain packaging for longer transit routes – • Explaining what this voluntary, but regulated program means what technology stands the test of time? to the pharmaceutical manufacturer and how the burden is to • Implementing continuous process improvement programs or the industry CAPA initiatives for temperature control supply chains • Understanding the levels of personnel, procedural, physical, IT and facility security – how to ensure your people and Panelists: processes are compliant Dr Ramendra N. Pandey, Senior Director, Head of • Proving Chain of Custody – Documentation, Application and ChemPharm Analytical Development, Analytical & Authentication Pharmaceutical Development Center, Janssen-Cilag, India • Comparing TSA to C-TPAT – an update on how to comply Brad Elrod, Manager, Global Logistics & Security, Pfizer with custom importation Todd DeVore, Director Product Development and Packaging, Brad Elrod, Manager, Global Logistics & Security, Pfizer AcuTemp Shipping In / Out of India: Examining the Representative, Port of Philadelphia, 10:00 US Customs and Border Protection Unique Regulations, Customs and Local Transport Partners Lunch and Networking for Speakers & 12:45 Examining storage conditions for temperature sensitive • Delegates samples Conducting excursion studies including exposure to light, • length of storage, variable weather Explaining what documentation, licenses or other • requirements are necessary for expeditious customs clearance in and out of India Sharing experience with U.S. customs clearance • Lessons learned in dealing with variable temperatures in route • from India to the U.S. and other regions Dr Ramendra N. Pandey, Senior Director, Head of ChemPharm Analytical Development, Analytical & Pharmaceutical Development Center, Janssen-Cilag, India Outstanding! – Director of Logistics, Chemical Biological Medical Systems Joint Project Management Office, Department of Defense 7
  8. 8. Day Two continued... Concurrent Tracks Track B – Supply Chain Management & ‘Last Miles’ Track A – Qualifying Your Cold Chain Keynote Session: A Model for Predicting Quality Keynote Session: Gaining Control of the ‘Last 1:45 1:45 and Integrity of Cold Chain Products During Mile’: How Can the Industry Implement Steps Transport - Identifying the Weak Link in Distribution to Ensure Product Integrity Downstream Leveraging shipping reports and transportation evaluations to Addressing lack of infrastructure in remote areas and some • • provide more information on time and temperature during shipping current initiatives to work around this • Using your knowledge and experience from your own cold • Gaining regulatory input on how to improve temperature chain to benefit the most from the gathered data control further down the supply chain • Improving relationships with providers to create a disciplined cold chain • Cold Chain monitoring and temperature excursion approaches and a common base for understanding of cold chain requirements • Appropriate data collection and analysis measures • Ensuring both businesses provide transparency for quick • Taking lessons from other industries to improve the healthcare response and targeted resolution when excursions occur supply chain • Sharing current evidence supporting the creation of a • Overcoming technical cold chain challenges in transporting to repeatable process for confidence in desired outcome remote areas Jim Bacon, Director, Global Demand Planning & Customer Rafik H. Bishara, PhD, Technical Advisor Operations, Talecris Biotherapeutics Case Study: Re-Defining Cold Chain Implementing Downstream Compliance Programs 2:30 2:30 Management Philosophy & Reducing to Ensure Clinical Supply Integrity in the ‘Last Miles’ Understanding the unique complexities of clinical supplies in Temperature Deviations • the last miles and some common misunderstandings Building a team & establishing a philosophy • • Gaining more control of clinical supplies and patient • Understanding the end-to-end process, defining the process compliance downstream by building clear communication and requirements, evaluating the existing controls, & implementing new procedures with key stakeholders - wholesalers, CRO, the new process pharmacists and physicians • Leveraging immediate benefits while planning for long-term • Updating study parameters and investor roles to the changing improvements dynamics of clinical trials today • Deviation reduction and management • Creating new pack outs to ensure product integrity Allen Napetian, Drug Product Finishing Associate Director, downstream that is easy to use for nurses and patients Genentech C. Ray Goff, Jr., Director, Vaccine R&D, Wyeth Research Afternoon Refreshment & Networking Break 3:15 A Novel Risk Management Approach to Shipping 3:45 Specialty Pharmacy Perspective: Correctly 3:45 and Distributing Temperature-Sensitive Products Handling of Temperature Sensitive Outlining the complexities of domestic and international shipping • Pharmaceutical Products in the ‘Last Miles’ to and distribution processes - including airports, docks, and a variety the Patient of methods of transport • Applying risk management principles to these complex processes Implementing initiatives to ensure product integrity during the • and establishing internal standards that support the risk-based trip from store to home approach • Initiative to ensure product integrity for high value • Utilizing the product’s stability data to support alternative shipping pharmaceuticals within USP quot;room temperaturequot; parameters conditions defined by temperature ranges, for a defined duration • Explaining the controls in place with Wal-Mart’s Mail Order of time, without adverse effect on its quality distribution site in Texas • Demonstrating the results of this novel approach of shipping at • Engaging more with manufacturers on how to control conditions outside the specified storage conditions - A cost- temperatures efficient, quality-driven, risk-based method for the distribution of James L. Soucey, Director of Clinical Services, Wal-Mart temperature sensitive products Specialty Pharmacy Gwyn Murdoch, Manager, Quality, US Distribution, Eli Lilly and Company Panel Discussion: Updating Your Risk Management Panel Discussion: Detailing a Clearer Picture of 4:30 4:30 Activities to Cover New Products, Routes and What it will Take to Gain Better Control of Regulatory Requirements including CRT Temperature Sensitive Medicines in the ‘Last Updating Risk Management activities to include longer routes, Miles’ • new routes and new climates in increasingly international cold Defining the risks of shipping longer distances to remote areas • chains Evaluating new strategies and technologies for pharmaceutical • • Working toward temperature mapping and updating manufacturers to implement to gain greater control temperature profiles for each and every route downstream • Discussing the value of temperature mapping transport partner • Discussing industry collaborations, standards and best practices vehicles All Track B speakers and participants are invited to join • Updating Risk Assessments to include compliance with CRT this discussion requirements All Track A speakers and participants are invited to join this discussion Closing Remarks from Chairperson and End of Conference 5:15 Register Today: Call 1-800-882-8684 • www.coldchainpharma.com 8
  9. 9. Pre-Conference Workshops Monday, September 22, 2008 8:00 am – 11:00 am Registration 7:45 Breakfast will be served A Quality by Design – What it Means to the Cold Chain The new paradigm adopted by FDA and the industry is Quality by Design The philosophy of the Validation, Qualification and Statistical Process Control • (QbD) which “means that product and process performance characteristics are (SPC) Application scientifically designed to meet specific objectives…”. QbD provides the Achieving QbD in Good Cold Chain Management Practices (GCCMP) • conditions for reaching a much preferred state where the industry, regulatory How will you benefit bodies and society have a mutual goal where the life sciences market produces Participants will examine the steps necessary to QbD according to current quality products for consumers. regulations and industry standards. The workshop leader will make the case What you will learn that quality should be built into the system in order to attain Good Global Cold The author of the presentation titled “QbD for GCCMP” reviews the Chain Management practices as well as operational and compliance excellence. Choose from Workshop A or B framework of QbD for GCCMP including examination of these key issues: Your Workshop Leaders: • Supply Chain Process Flow Diagram Neritan Mustafa, Life Sciences Program Manager, Sensitech • Implementing relevant regulations Mark Maurice, Senior Project Manager, Sensitech Inc. 8:00 am – 11:00 am Registration 7:45 Breakfast will be served B Master Course for Today’s Packaging Engineers With increasing global supply chains and uncertain weather conditions, How are phase change materials incorporated into a passive thermal • packaging engineers are facing complex challenges in updating packaging container design? design, testing and validation for longer transit routes. Designing Environmentally Friendly Shippers • • Discuss materials and designs that can be utilized to reduce environmental What you will learn impact of shipping temperature sensitive payload • What information is necessary and how to acquire it for a good • How green designs add to your overall ROI requirements capture • How green designs ensure that your payload and personnel remain safe • Quick Overview of Insulation & Heat Transfer Key Points - R-value and Latest New Technologies in Thermal Shippers - Identifying and discuss new • thermal conductivity technologies and how they are improving thermal shippers • Thermal Packaging Testing & Live Shipment Testing • Protocol design & Test equipment selection How you will benefit • Laboratory & equipment certification This intensive workshop will provide today’s packaging engineers with the • Proper steps for Designing a New Shipper and Building a Business ROI most up-to-date knowledge and information to update their pack outs and • Proper phases for new shipper design packaging practices. • Typical methods for tooling for each phase Your Workshop Leader: George Flora, President, Minnesota Thermal Science 11:15 am – 2:15 pm Registration 11:00 Lunch will be served C Outsourcing Your Cold Chain Project Management: Opportunities & Strategies for Success While operating budgets and resources are contracting, understanding the Monitoring Strategies: Where and when they are needed, how to develop • importance of proper planning and management of cold chain requirements is an effective program and air vs. product temperature increasing, along with regulatory involvement and oversight. In order to meet these Thermal Mapping: packaging, trailers, warehouses and shipping lanes • growing and wide-ranging requirements in a thorough, robust and timely manner, Shipping Options: Plan for excursions • each component must be handled in a highly coordinated fashion with strong Keeping in sync with industry guidelines and regulatory directions (USP • project management methodologies regardless of whether the work is being 1079, TR 39, etc.) performed internally or with third-party providers. How you will benefit What you will learn By attending this workshop you will gain a better understanding of: The links, interactions and steps along the entire cold chain from needs assessment • How the many parts of cold chain logistics and distribution interact through finished goods distribution. Additionally, we will review how third-party cold • The importance of managing all the aspects in a highly coordinated fashion chain solution providers can help you manage and execute your project needs. • How to more effectively manage the process Roundtable discussions and case studies will cover: • How to successfully outsource cold chain project management Choose from Workshop C or D • Project Specifications: packaging, storage, handling and movement Your Workshop Leaders: • Temperature Profile Development and Temperature Criteria Development Robert (Bob) Bohne, VP, General Manager, Cold Chain Technologies • Controlled Room Temperature Solution Strategies Jeff Simpson, Director of Engineering & Technical Services, Cold Chain • Package Design: process, design trade-offs, component attributes, advanced Technologies modeling techniques • Multi-use Packaging: Planning for a matrix of product variety Anthony Rizzo, Project Manager, Cold Chain Technologies • Documentation Requirements Jim Nilsen, Project Manager, Cold Chain Technologies • Packaging Issues: Storage, Re-Use, Disposal, Refrigerant Conditioning and Handling 11:15 am – 2:15 pm Registration 11:00 Lunch will be served D Revelations in Heat Transfer Packaging issues are multifaceted. Efficiency, cost and sustainability are at the may come into play? core of the problems faced in the packaging of temperature sensitive Why is it important to complete detailed temperature mapping? • pharmaceuticals. How can I ship longer distances to remote areas? • What will you learn How you will benefit quot;One can always tell how tall a building is going to be by how deep of a hole This workshop will demonstrate answers to each of the questions above. The is dug.quot; -Albert Einstein. heat transfer principles discussed will be based on science and math that will help in answering questions of efficacy. They will aide you in the design It is with this quote in mind that you will examine heat transfers and learn: process and help eliminate the misconceptions that are costing the Why is it so difficult to get an extra day out of a packaging solution in one part of • pharmaceutical industry time, energy and money. the country versus another? Or one part of the year versus another? • What does the amount of product matter when shipping? Your Workshop Leaders: How does elevation affect heat transfer? Rob Abramovitch, General Manager, Insulation, Polyair • • When deciding upon different insulating materials, what are some of the Brian Martin, VP, Consumer Markets North America, Polyair variables that need to be examined? Rudy Ponce, Sr. Director of Marketing, Polyair How do I adjust my SOP's to take into consideration all of the variables that • 9
  10. 10. 2:30 pm – 5:30 pm Registration 2:15 E Critical Designing, Evaluating and Testing Temperature Sensitive Product Packaging This comprehensive workshop is tailored for people responsible for cold chain How you will benefit shipping of pharmaceuticals. It will include detailed steps required for success • Walk away better prepared to define scope, schedule and cost of cold chain in selecting and designing temperature controlled shipping solutions. project Participants will gain a precise understanding of the most thorough and • Attain knowledge of design choices of refrigerants, insulation and their effective approach to critical details related to packaging including design, interaction testing and qualification. • Gain an understanding of the elements and advantages of well defined test protocol What you will learn • Obtain a clear concept of the package testing and qualification process • Defining the project scope • Understanding design options and tradeoffs Your Workshop Leaders: • Methods to establish temperature profiles Anthony Alleva, Project Engineer & Mike Paterno, Project Manager, TCP Choose from Workshop E or F • Elements of a temperature sensitive package design Reliable • Examples of shipping solutions 2:30 pm – 5:30 pm Registration 2:15 F Best Practices in Temperature-Controlled Transportation This presentation will cover best practices that support the pharmaceutical How you will benefit industry’s regulatory compliance requirements relative to the transportation of Through case examples and interactive exercise, you will understand how temperature-control product. This includes case studies of truck validation and concepts of validation can be applied to enhance the consistency and quality air transportation environments and a discussion of relative strengths and of service in the transportation arena, including: weaknesses of various approaches at common temperature ranges: 2-8° C, • Transportation Validation Master Plan deep frozen and controlled room temperature. • Truck/aircraft thermal mapping • Exclusive-use truck validation case study (IQ/OQ/PQ), including a discussion What you will learn of common errors in truck qualification approaches With a dual focus on quality both in transportation and in temperature control, • Temperature-controlled international air shipment case study you will gain insight to the carriers' quality systems including: • Practical recommendations for implementing new regulatory and industry • Documentation audit trail guidelines: <USP 1079> and TR-39 • Real-time monitoring • Discussing pre-forma transportation quality agreements and considerations • SOPs, including contingency planning to address in the design of a transportation plan • Training Your Workshop Leader: Karl Kussow, Manager Quality and Validation, FedEx Custom Critical 5:45 pm – 8:45 pm Registration 5:30 Dinner will be served G How to Meet GMP and GDP Regulations Using Temperature Monitoring Solutions This workshop will share case studies and best practices related to cold chain How you will benefit management during clinical trials, warehousing, shipment and distribution. This session will include round table discussions about the current GMP and GDP regulations surrounding Temperature Monitoring. DeltaTRAK will share What you will learn with you important educational information about cold chain management of Attendees will be invited to participate in interactive exercises covering: temperature sensitive (bio) pharmaceuticals. • Proper methods for choosing and validating a Temperature Monitoring Solution Your Workshop Leaders: • The challenge of monitoring quot;The Last Milequot; to the consumer Martina Brennan, National Sales Manager, ColdTRAK • Selecting the right solution from available environmental monitoring Charles Craig, Validation and Technical Engineer, DeltaTRAK Choose from Workshop G or H technologies 5:45 pm – 8:45 pm Registration 5:30 Dinner will be served H Temperature Mapping, Supply Chain Planning and Specialty Logistics for International Clinical Trials The dynamics of clinical trials have changed drastically with increasing multi- How will you benefit: national trials, at home clinical administration and changing patient In breakout discussion groups, you will explore: populations. This workshop will look at how you can update your cold clinical • How to manage risk while minimizing costs supply operations to meet these increasing challenges. • Updating your temperature mapping for international clinical trials • Implementing best practices for temperature controlled clinical supply What will you learn: operations • How to meet the demands of global clinical trial supply planning • Dealing with incomplete stability data and information • Implementing flexible procedures and sufficient contingency plans • Delivering clinical supplies to remote areas and clinical sites • Updating your practices to control temperature sensitive supplies to the patient with increasingly geriatric patient populations Your Workshop Leader: • Overcoming challenges in using less traveled shipping lanes Tony Mistretta, Distribution Manager, ALMAC GROUP Register Today: Call 1-800-882-8684 • www.coldchainpharma.com 10

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