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Clinical Trial Supply Europe Conference

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Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to …

Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials.

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  • 1. Register and Pay Before the 24th September and Save up to €1,797! Limited to the first 20 registrants! Two Day Conference: 27th-28th January 2011 Pre-Conference Focus Day 26th January 2011 Venue: World Trade Centre, Rotterdam, The Netherlands Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials World’s leading clinical trial supply experts will help you to: Introducing Europe’s largest and most Cut overages and save money by successfully adopting S&OP processes prestigious clinical trial supply speaker panel drawn from commercial supply into a clinical setting: GlaxoSmithKline show Expert advisory panel: you how they increased supply flexibility whilst positively impacting their Tony Street, Worldwide Director Clinical Trial Supplies, bottom line Allergan Maintain compliance with the evolving regulatory landscape: the Amandeep Madra, Director, Supply Chain Logistics, MHRA and Dutch Healthcare Inspectorate discuss the latest changes to GlaxoSmithKline Annex 13 and GDP regulations and how you can meet these requirements in Juergen Rapp, Global Head, Supply Planning, Novartis your business Robert Smith, QP and Director, Clinical Pharmacy Research Services, Genzyme Effectively support emerging clinical trial designs such as adaptive trials: Merck, Sharp and Dohme share their experiences of successful Engage with 30 industry speakers including: adaptive trials and the project team structures that deliver success Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK Ensure product viability of temperature controlled clinical materials by establishing an effective cool chain on a global and local scale: the PDA and Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG ActoGeniX N.V. discuss the latest strategies to ensure success on a global USA Branch, PDA scale Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma Guarantee uninterrupted supply in emerging markets such as Eastern Europe and Latin America: Galapagos NV and Merck share their most Gary Cunnington, Global Head, Clinical Trial Supply, recent experiences and show you how to overcome the major hurdles Respiratory, Boehringer Ingelheim Dorthe Lerche Berg, Head of Department, Clinical Supply www.clinicalsupplyeurope.com Coordination, Lundbeck Danny Raymakers, Head of Supply Chain Management, TOP 4 reasons to attend Europe’s leading industry forum: Clinical Supply Management, Johnson & Johnson 1. Exclusive to Pharma IQ: Clinical Trial Supply Leaders Focus Day! NO presentations, 100% discussion! 2. Evening Drinks Reception and Gala Dinner: a great opportunity to increase your network Bernadette Cunningham, Director, Pharmaceutical 3. Exclusive to Pharma IQ: Interactive Crisis Management Session: Develop a plan of action for a Operations, OSI Pharmaceuticals particular crisis you will come face-to -face with in your work. Find out how others tackle the same Trevor Knott, Associate Director Clinical Supplies, challenge Scientific and Operational Clinical Support, Eisai Ltd 4. 30 expert speakers: The largest gathering of expert clinical trial supplies speakers “Very valuable, Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering Pharma AG Clinical Trial Supply Leaders Focus Day: inspired.” Bernd Schaden, Clinical Supply Chain Manager, Global NO presentations, 100% peer-to-peer discussion! Novartis AG Supply Chain, Baxter Innovations GmbH Interactive Specialist Discussion Forums: Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm A: Developing a Robust and Compliant Process for Temperature Controlled Clinical Solutions & Chair, Global Clinical Supplies Group, Inc. Materials Mark Harmer, Global Clinical Supplies Operations B: Selecting the Correct Outsourced Partners and Building the Right Relationship for Manager, Merck, Sharp and Dohme Effective Vendor Management Alfredo D’Addio, Strategic Planner, Global Investigational C: Innovations in Clinical Trial Supplies Labelling and Packaging Material Supply Chain, Celgene Corporation See inside for more details and package discounts… Sponsors & Exhibitors see inside for more speakers… Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 2. CLINICAL TRIAL SUPPLy EUROPE SPEAKER PANEL Dear Colleague, I wanted to take this opportunity to welcome you officially to Pharma IQ’s Clinical Trial Supply Europe Conference. In an era of cost cuts and lean processes, the clinical trials supply network had come under an increased amount of scrutiny to cut overages, cut costs and increase flexibility. Along with the executive advisory board and speakers, we have developed the most time specific and relevant agenda for clinical trial supply professionals, providing 3 days of new presentations, exclusive interactive discussion sessions and countless networking opportunities to provide you with the tools to become fitter, faster and drive the critical transformation you need in 2011 “Only 13 percent of clinical trial material shipments arrived on time and, even then, 1 in 10 were incomplete” Survey cited by Fisher Clinical Services White Paper 2010 I came across this quote whilst conducting agenda research and I’m sure you’ll agree, it really sums up the challenge this area is currently facing – the challenge you are facing. I invite you to join us at the conference in January and start actively ticking off the major things on your clinical trial supply to do list for 2011. The speakers, sponsors and advisory board look forward to seeing you next January in Rotterdam for the Clinical Trial Supply Europe Conference. Kind Regards, “I have to say that the agenda looks Nichola Welch really exciting with many relevant Senior Conference Director, Pharma IQ (a division of IQPC) sessions that relate to our daily work” Kim Tang Hvistendal, Lifecycle Pharma A/S With Special Thanks To Our Executive Advisory Board: Tony Street, Juergen Rapp, Worldwide Director Clinical Trial Supplies, Global Head, Supply Planning, Allergan Novartis Amandeep Madra, Robert Smith, Director, Supply Chain Logistics, QP and Director, Clinical Pharmacy Research Services, GlaxoSmithKline Genzyme your Distinguished Speaker Faculty Bernd Schaden, Clinical Supply Chain Kim Tang Hvistendal, Manager, Global Supply Chain, Director, Clinical Supply, Ian Holloway, Manager, Defective Baxter Innovations GmbH LifeCycle Pharma Medicines Centre, MHRA, UK Steven A. Jacobs, MBA, R.Ph., Steve Benson, Dr Rafik H. Bishara, Technical Advisor President, Global BioPharm Solutions Supply Chain Systems Manager, and Chair PCCIG USA Branch, PDA & Chair, Global Clinical Supplies GlaxoSmithKline Group, Inc. Amandeep Madra, Supply Chain Lorna Briddick, Global Clinical Director, GlaxoSmithKline Mark Harmer, Global Clinical Supplies Regional Lead, Latin Supplies Operations Manager, America, Merck Juergen Rapp, Global Head Supply Merck, Sharp and Dohme Planning, Novartis Steve Healy, Sales and Marketing Vivek Peshkar, Senior Drug Supply Manager, SCA Cool Logistics Alfredo D’Addio, Strategic Planner, Management, Supply Planning and Global Investigational Material Supply Christian Knoblich, Commercial Design, Novartis Chain, Celgene Corporation Director, Movianto Group Uffe Larsen, Team Leader, Clinical Danny Raymakers, Head of Supply Tony Moult, Proprietor, Supplies, Novo Nordisk Chain Management, Clinical Supply A.N. Moult Consultancy Services Management, Johnson & Johnson Dorthe Lerche Berg, Head Of Sam Corveleyn, Director, CMC and QP, Department, Clinical Supply Bernadette Cunningham, ActoGeniX N.V. Coordination, Lundbeck Director, Pharmaceutical Operations, Marianne Veighey, Team Manager, OSI Pharmaceuticals Gary Cunnington, Global Head, Supply Chain, Astrazeneca Clinical Trial Supply, Respiratory, Trevor Knott, Associate Director Boehringer Ingelheim Dr Riekert Bruinink, Chairman, PIC/S Clinical Supplies, Scientific and GDP Working Group, Member of Operational Clinical Support, Eisai Ltd Dr Almut Malone, the EMEA GDP Drafting Group, Dutch Global Logistics Clinical Supplies, Annegret Van der Aa, Healthcare Inspectorate Bayer Schering Pharma AG Clinical Trial Manager, Justin Doel, Head, Global Clinical Galapagos NV Bent Christensen, Team Leader, Supplies, Novartis Vaccines Clinical Trial Supply, Novo Nordisk Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 3. PRE-CONFERENCE SPECIALIST DISCUSSIONS: WEDNESDAy 26TH JANUARy 2011 Specialist Discussion Forum A: 09.00 – 12.00 Specialist Discussion Forum B: 12.30 – 15.30 Developing a Robust and Compliant Process for Innovations in Clinical Trial Supplies Labelling Temperature Controlled Clinical Materials and Packaging In this interactive discussion you will join fellow professionals In this peer-to-peer focused discussion group, attendees will charged with supplying temperature controlled clinical materials. explore the latest packaging and labelling technologies available With the multitude of challenges that can occur when working and understand how these can be applied in different countries with this type of product, it is essential that you have a clear and situations. programme in place to maintain an effective temperature You will also discuss the latest regulatory hurdles to be aware of controlled supply for your clinical materials. and how these can and do differ from country to country. This workshop will discuss: 1. Effective assessment techniques of any logistics challenges when establishing a temperature controlled distribution to depots and clinical sites Specialist Discussion Forum C: 16.30 – 19.30 • Different ranges of conditions - deep frozen, frozen, Selecting the Correct Outsourced Partners and refrigerated and other needs • Active systems Building the Right Relationship for Effective • Passive systems Vendor Management 2. Understanding and managing risk In this hands-on workshop, attendees will get the chance to • Rate of failure discuss tried and tested best practices when it comes to selecting • Real product risks and managing outsourced partners. It is crucial to keep these • Patient treatment risks relationships working fluidly as a part of your supply chain to • Financial risk ensure consistent supply for clinical trials. Topics to be discussed • Administrative and inter-departmental expectation risks include: 3. QA for temperature sensitive materials both in transit and during storage at the clinical site • Sourcing and selection strategies that work • Use of temperature monitors • Building the relationship and establishing roles and responsibilities one each side • Obtaining data from clinical sites • The challenges that can arise and how you can navigate • Timely review of data past them • Handling of temperature excursions • Case studies to work through in smaller groups •Administrative •Minor Discussion Facilitator: •Major Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm • Problem identification, elimination and process improvement Solutions and Chair, Global Clinical Supplies Group, Inc. 4. Stability issues • Ensuring stability during storage and transit 5. Temperature controlled supply in emerging markets Discussion Facilitator: Tony Moult, Proprietor, A.N. Moult Consultancy Services Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 4. PRE-CONFERENCE FOCUS DAy: WEDNESDAy 26TH JANUARy 2011 Clinical Trial Supply Leaders Focus Day: Strictly No Presentations Pharma IQ’s Clinical Trial Supply Leaders Focus Day delivers a unique opportunity that will go past the tools and techniques to discuss how you, as a business leader, can truly enable and embed key strategies into your clinical trial supply operations and build a culture that drives the critical transformation you need during 2011. Through a leader-to-leader debate driven format, you’ll be able to address your most critical clinical trial supply challenges from a director level, ensuring you leave with solutions tailored to your development needs. The focus day agenda is constructed to help make sure your clinical trial supply chain business is ready to excel in 2011 by becoming fitter, faster and more cost effective. Here’s how: 1. First of all you’ll find no 2. Each discussion is led by 3. You can submit your key 4. You’ll find no sales pitches standard presentations, no a different leader to reflect challenges and requests for – strictly business-to-business self publicity - only complete the different approaches to discussion to the group ahead knowledge sharing information sharing and clinical trial supply across real of time by sending them to genuine discussion between organisations today, making it nichola.welch@iqpc.co.uk pharmaceutical and the perfect chance to compare biotechnology clinical trial and contrast theory in practice supply directors All this makes the Clinical Trial Supply Leaders Focus Day an unmissable chance to benchmark your supply networks and strategies against others and strengthen your development plan for the year ahead. N.B You will be asked to share your own experiences during the focus day to make this truly interactive. So come ready to SHARE! 09.25 Pharma IQ Welcome and Chair’s Opening Remark’s 13.10 Creating a Clinical Trial Supply Network to Support New Initiatives Such as Adaptive Trials 09.30 Efficiently Selecting and Managing a Global Clinical Supply Team: The Ingredients of a Successful Team •Understanding where the complications come with innovations in trial formats when supply is needed • How to ensure you have the right team in place for the job in hand •How to ensure you have a platform ready to facilitate these trial types • Evaluating the different management structures you can adopt to effectively manage a global network effectively • Assessing which one will work for your company •Sharing of specific experiences and lessons learned Danny Raymakers, Head of Supply Chain Management, Clinical Supply Juergen Rapp, Global Head, Supply Planning, Novartis Management, Johnson & Johnson 10.20 Understanding the Behavioural Traits and Styles of Your Business 14.00 Effectively Enhancing Your Distribution Practices Through Resource Partners to Really Make The Relationship Work Pooling • What drives your business partners and how can you align this with your own goals? •Understanding the business benefits of pooling resources for distribution • Ensuring you have the correct personalities on both sides to work as one team •The practicalities of changing your distribution to this formula: the planning process and what successful implementation looks like • Negotiating other barriers such as time, culture and language Trevor Knott, Associate Director Clinical Supplies, Scientific and •Discussion of other experiences moving to a pooled resources model Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Operational Clinical Support, Eisai Ltd Boehringer Ingelheim 11.10 Networking Coffee Break 14.50 Networking Coffee Break 11.30 Benchmarking Performance Measures for External Partners 15.10 Successful Interface Management For Clinical Trial Supplies • What are the best metrics you can use to assess and compare current partners? •Understanding the challenges that can arise with managing multiple interfaces • how this can be effectivelytranslated to enhance partner performance •Where, as senior manager, can you plan for and manage this? • Specific experience from all attendees and discussion on best practice Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline Dr Almut Malone, Global Logistics, Clinical Supplies, Bayer Pharma AG 16.00 Close of Clinical Trial Supply Leaders Focus Day 12.20 Networking Lunch Break Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 5. CONFERENCE DAy ONE: THURSDAy 27TH JANUARy 2011 07.45 Coffee and Registration 14.15 Interactive Roundtable Discussion 09.00 Pharma IQ Welcome and Chair’s Opening Address This is your chance to discuss key topics and challenges in smaller groups. Attendees will be able to share their own experiences Ensuring Complete Compliance With Regulatory Bodies Across Europe and hear those of others, exchange ideas and get clear answers to specific 09.10 Regulatory Update: Regulatory Views and Concerns for Clinical questions. So, in order to make the most of these interactive sessions, Supplies REGULATORY participants should come armed and ready to share their own experiences UPDATE • Annex 13 then andthe Clinicalwill theDirectivechanges affect you? now: how recent and have clear questions they need answers to. • Improvementsand impact Trials expectations to and related legislation: Choose from one of the following: • Defects, recalls and quality system problems: preparing and considering in advance A: Ensuring Clinical Trial Supplies Success in Emerging Markets Attendees will share their experience of working in emerging markets; the main Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK challenges that arise and each person’s approach to overcoming them. Annegret Van der Aa, Clinical Trial Manager, Galapagos NV Reacting to a Cost Driven Environment by Effectively Building Efficiencies into your Clinical Supply Network B: Ensuring Successful Temperature Controlled Supply of Clinical 09.50 Case Study: How to Establish a Demand and Operations Planning Materials This roundtable will focus on how to establish and manage a cool chain specifically Process in the Clinical Supply Chain for temperature sensitive clinical materials effectively. The pitfalls to try and (using risk based forecasting and planning in a clinical trials supply chain) • The benefits of using an S&OPchain drawn from a commercial supply CASE STUDY avoid, the regulations to comply with and how to make this as green and cost process efficient as possible. chain in a clinical trial supply • Discussion of the business employed and the different phases ofways of strategy execution Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA • The impact upon working processes, information systems and C: Innovation in Packaging and Labelling • How was the risk mitigated in this to ensure supply was not disrupted? This roundtable will allow attendees to discuss the key regulations within • Managing the(project example)across the R&D supply chain change process packaging and label design that must be taken into account as well as new • A case study Director, Supply Chain lessons learned and the technologies that may be able to help with challenging areas such as blind and double blind trials and adaptive trials. Amandeep Madra, Logistics, GlaxoSmithKline • Automation in packaging 10.20 Successfully Adapting Proven Logistics and Distribution Models • Green packaging innovations Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, Lundbeck to Your Clinical Trials Supply Chain • Developing a secure strategy for temperature controlled storage and distribution D: Successful Strategies For Working With Comparator and Global Trials • Working with 3rd parties to establish uninterrupted supply of clinical trial materials When working with comparators, there is always the uncertainty or ensuring consistent supply and product quality. This roundtable will discuss how you can • Solutions for labelling and packaging mitigate against the risks here and ensure the trial is never stalled on account of • The importance of effective returns management in a clinical supply network supply stock-out on the comparator side. • Discussion of case study examples Christian Knoblich, Commercial Director, Movianto Group Bernd Schaden, Clinical Supplies Manager, Baxter E: Maintaining Compliance with cGDP and cGCP Regulations 10.20 Networking Coffee Break This roundtable will allow attendees to focus not only on the regulations themselves, but also the sticking points that can sometimes leave a company Supporting Emerging Clinical Trial Models and Integrating vulnerable to non-compliance. How can you avoid this? Supply Chains Effectively Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK 11.10 Case Study: Supporting Emerging Trends of Adaptive Design with F: Transport and Customs Challenges for Clinical Supplies Clinical Supply This roundtable will look to discuss the challenges that arise with getting • Adaptive design studies and benefits to clinical development investigational materials and in and out of countries as well as looking at specific • CASE STUDY Overcoming the challenges forecasting and simulation pose countries where this proves more of a challenge. Participants will also be asked to • Challenges to the clinical supply chain: design feasibility (blinding, schedule management and IVRS) share their own experiences. Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair, • Project team structures that deliver success for adaptive designs Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp Global Clinical Supplies Group, Inc. and Dohme G: Partnering with Vendors to Ensure Quality and On Time Delivery The reliance on 3rd party suppliers and logistics providers is high in any clinical 11.40 Case Study: Developing an Integrated Supply Chain By supply network and it is always difficult to manage multiple parties to ensure Implementing Supply Chain Management Frameworks complete alignment. This roundtable will focus on best practice approaches to CASE STUDY • Discussion of the benefits of applying a planning framework to your clinical supplies managing this network effectively and make sure no costly slip-ups occur. Bernadette Cunningham, Director, Pharmaceutical Operations, • What differentcost and waste management? when looking at aspects such as quality vs. planning methods are available OSI Pharmaceuticals • The automated systems that are available to support this Danny Raymakers, Head of Supply Chain Management, Clinical Supply H: Removal of Expiry Dates From Investigational Material Labels in Europe Management, Johnson & Johnson With the gap now closing on turning concept to reality, it is important to start looking internally at how your company is fixed to support this industry shift. 12.10 Spotlight Session This roundtable will discuss the recent experiences of those who have piloted the This session will be dedicated to a leading service provider from within the removal of expiry dates from labels. The lessons learned and how you can move clinical trial supply arena, offering you the opportunity to hear first-hand forward in your own company. how the latest technology innovations could help you reach your CSM goals Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk in 2011. I: Clinical Trial Supply for In-License Products 12.40 Networking Lunch Break This roundtable will the challenges that arise with clinical trial supplies for in-licensed products, the main hurdles you have to overcome and how to do this. Participants will share their experience and potential strategies to move forward. Marianne Veighey, Team Manager, Supply Chain, Astrazeneca Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 6. 15.00 Case Study: Successfully Developing Clinical Material Resource 15.30 Developing Temperature Controlled Packaging for Effective Pooling Into Your Distribution Strategy Distribution in Regional and Global Clinical Trials? CASE • Fullydistribution the rationale behind adopting this method of storage understanding • Innovative technology packaging solutions to meet specific criteria and STUDY and • Fit for purpose: designing • Highlighting the challenges that were and are being faced with the change certain temperature ranges of structure • Total cost ofsustainabilitycalculating the packagingtemperature control shipped ownership: cost per liter volume • What are the next steps? and business benefits for the venture and what are the realised costs • shipping of pharmaceuticals Assessing initiatives for today’s Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Steve Healy, Sales and Marketing Manager, SCA Cool Logistics Boehringer Ingelheim 16.00 Networking Coffee Break Stream A: Ensuring Product Integrity By Designing and Stream B: Enabling Faster Distribution By Developing a More Executing a Successful Temperature Controlled Network for Flexible Clinical Distribution Network Clinical Supplies Stream Chair: Rafik H. Bishara, Stream Chair: Dr Almut Malone, Global Logistics Clinical Supplies, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA Bayer Schering Pharma AG 16.30 Ensuring Compliance with Global Requirements for the Storage 16.30 Regulatory Update: Developments in Good Distribution Practice and Distribution of Temperature Sensitive Clinical Materials Regulations and the Impact on Clinical Supplies • Examining industryand processes clinical trials and their impact on REGULATORY REGULATORY UPDATE trends in global UPDATE • Outlining the new GDP regulationsGDPgeneral within the EU and how in distribution chains • Best practicesdocumentation refrigerated shipments from international for frozen and • these have/will affect clinical supply guidelines Evaluating the key changes in the • Labelling and clinical trials for return samples to labs • Understanding any key temperature control aspects that need to be • Effective tracking andfor Good ColdofChain Management practices for monitoring investigational materials taken into consideration for cool chain products. • Implementation of revised GDP guidelines • Developing a system your company clinical supplies within Dr Riekert Bruinink, Chairman, PIC/S GDP Working Group, Member of the Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA EMEA GDP Drafting Group, Dutch Healthcare Inspectorate 17.00 Case Study: Assessing and Selecting Sub-Contractors for 17.00 Case Study: Successfully Developing Predominately Airborne Packaging, Labelling and Clinical “Cold Chain” Supply Clinical Trial Shipping Programme CASE STUDY • Setting up packaging and distribution processes, KPIs and metrics with CASE STUDY • Understanding the drivers behind the use of air transport rather than land partners • Audit frequency and schedule temperature sensitive IMPs, • Using airborne supply networks to reduce the risks in customs hold ups • Deciding bestmonitoring and reporting procedures temperature practice for packaging and temperature deviations • Establishingtimely accountable KPI’s with your partners to ensure high clear, • A QP point ofand IMPs safe for administration keeping partners accountable view: temperature excursions and quality and supply Bent Christensen, Team Leader, Clinical Trial Supply, Novo Nordisk • Implementing continuous long-term improvements with partners Sam Corveleyn, Director, CMC and QP, ActoGeniX N.V. 17.30 Open Discussion: Implementing New Temperature Monitoring 17.30 Case Study: Managing the Interface in Distribution of Clinical Processes and Technologies to Avoid Lost Investigational Materials Supplies • Discussion of the different technologies currently available See www.clinicalsupplyeurope.com for updates • Integrating these intowith the regulations CASE your current strategies STUDY Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering • Ensuring Day One Speakers and Steam A attendees are invited to join this Conference compliance Pharma AG discussion 18.00 Chair’s Closing Remarks and End of Day One 18.15 Networking Drinks Reception in the Exhibition Hall 19.30 Gala Dinner and Pharma IQ Clinical Trial Supply Award After a full first day of discussion and idea sharing, join your peers in this ultimate networking occasion. Sit back, relax and enjoy a sumptuous 3 course meal with wine, talk over the topics of the day and take this opportunity to really get to know your fellow delegates and increase your network of contacts in the area. Pharma IQ Clinical Trial Supply Award also offers a great opportunity for you to recognise excellence within the industry. See www.clinicalsupplyeurope.com. for more information on how to nominate your project of the year! Claim your free Kindle, iPod Nano or €100 Amazon Vouchers! “Very valuable.” Early Booking Treats: Book and pay by 8th October 2010 and receive an IQ Treat! Marco Luyten, Kerry Logistics Pick your treat from the options below: 1. Kindle Wireless Reading Device, Wi-Fi, 6” Display, Graphite - Latest Generation Pharma IQ event attendee 2. New Apple iPod nano with Camera 8GB (5th Generation) – Black 3. @100 Amazon Vouchers
  • 7. CONFERENCE DAy TWO: FRIDAy 28TH JANUARy 2011 07.45 Coffee and Registration 12.40 Networking Lunch Break 08.20 Chair’s Opening Remarks Effectively Planning for the Challenges that Occur When Working With Comparator Studies Establishing Multiple Supply Networks and Moving your Business Closer to Removing Expiry Dates from Labels in the EU Using IRT 13.30 Spotlight Session This session will be dedicated to a leading service provider from within the 08.30 Case Study: Let’s Start Six Global Phase III Trials in One Year! Comparator Sourcing arena, offering you the opportunity to hear first-hand • Generating a global booklet label to supportsix trials effectively: outlining multiple clinical trials the latest strategies in comparator sourcing. CASE STUDY • Create a supplyand the answers supply all the challenges strategy that can 14.00 Panel Discussion: Overcoming Challenges With • How to program the IVRS (one massive system or multiple individual) Alfredo D’Addio, Strategic Planner, Global Investigational Material Supply Comparator Sourcing and Comparator Consistency for Global Clinical Trials Chain, Celgene Corporation • The benefits and drawbacks of key strategies that can help ensure consistent supply of comparators 09.10 Panel Discussion: Removing Expiry Dates from CMP • Central vs.factorssourcing: which isthe answer? to choose and why? local the right path Labelling: The Business Benefits and the Challenges • Are there thethat can change • Discussion surrounding the rationalewhat themoving towards the removal behind • Understanding regulations surrounding comparator sourcing and packaging of expiry dates from CTM labels and true benefits will be • challenges seen by the ISPE/PDA task force? What are the perceived challenges and how do these match to the actual Bernd Schaden, Clinical Supplies Manager, Baxter Lorna Briddick, Global Clinical Supplies Regional Lead, Latin America, Merck • What areand realised? to be taken by the industry to ensure this is fully adopted the next steps Establishing a Robust Clinical Supply Network in Emerging Markets Panelists Include: and Effectively Working with External Partners Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, 14.30 Case Study: Planning and Executing Effective Clinical Trial Supply Boehringer Ingelheim in Eastern European Countries: The Small Company Perspective Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk • Outline of thethe planning phase: approachEastern European Countries rationale behind working in • Experience and hurdles so far? Discussion of and challenges 09.40 Case Study: Innovative Approaches to Increasing Efficiency by • Relationship management strategies that ensure you work with your Maximising the Potential of Your Interactive Response Technology (IRT) • partners as a cohesive team CASE STUDY • How to incorporate IVR and of this technologyyour current supplydelivery IWR systems into chain • What are the lessons learned? • Managing the expectationsdata and system haswith thecontrol of levels reality Annegret Van der Aa, Clinical Trial Manager, Galapagos NV • Discussionsbenefits ofIRT through integration of information as to how helped supply • Maximising systems Steve Benson, Supply Chain Systems Director, GlaxoSmithKline 15.00 Networking Coffee Break 15.30 Case Study: Successful Delivery and Management of Clinical Supplies for Latin America 10.10 Networking Coffee Break CASE •Latin America’sClinical Supplies Regionalof pharmaceutical clinical trials importance in the future STUDY •The importance of establishing a robust supplyRole to support clinical Introduction of Lead 10.40 Interactive Crisis Management: Ensuring Your Clinical Supplies Still Make It! • trials in Latin America network Unexpected challenges can arise anywhere, anytime, leaving you very little time to prepare and regroup. This dedicated, interactive session will •Highlights of some key challenges and opportunities with Latin American countries see attendees divided into small groups and given a “disaster scenario” to work through. Your task, as a team, is to devise a strategy to ensure •Discussion of specific cases and the lessons learned Latin America, Merck Lorna Briddick, Global Clinical Supply Regional Lead, your clinical supplies arrive at their required destination with as little disturbance as possible. 16.00 Panel Discussion: Effectively Selecting and Working Group Leaders will be: With External Partners A. Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, • Best practice approaches to selectingoutsourcing on both sides as the key a partner Lundbeck B. Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp • Understanding the keypartnership: how can you ensure you have all of this to creating a working drivers when and Dohme information? C. Bernadette Cunningham, Director, Pharmaceutical Operations, OSI Pharmaceuticals • Developing the relationship:and use this effectively? develop a strong relationship with a partner how can you effectively D. Tony Moult, Proprietor A.N. Moult Consultancy Services Annegret Van der Aa, Clinical Trial Manager, Galapagos NV E: Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair, Vivek Peshkar, Senior Drug Supply Management, Supply Planning and Global Clinical Supplies Group, Inc. Design, Novartis F: Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma G: Justin Doel, Head, Global Clinical Supplies, Novartis Vaccines 16.30 Chairperson’s Closing Remarks and Close of Conference 11.40 Case Study: Demand Driven Supply of IP: Creating Flexibility and Cutting Cost in an Established Clinical Supply Network CASE • Analysis of of the strategythat neededandbe addressed phases of execution the problems to Register and Pay Before the 24th • Discussion risk mitigatedemployed ensure supply was not disrupted? STUDY the different • How was the benefits that have been seen and the lessons learned in this to September and Save up to €1,797! • What are the Vivek Peshkar, Senior Drug Supply Management, Supply Planning and Limited to the first 20 registrants! Design, Novartis Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 8. ABOUT THE EVENT Join your peers at one of a number of networking events at Pharma IQ’s Clinical Trial Supply Europe Conference Get ready for 3 full days of targeted discussion and networking in one of the many dedicated sessions where you can exchange ideas on specific aspects of clinical trial supply, increase your network of professionals in the area and just get to know people. This will build up to an evening drinks reception and gala dinner at the end of conference day one, where you can enjoy a glass of wine, dinner and the chance to relax with your peers. Who will be at Pharma IQ’s Clinical Trial Supply Europe Conference? Job Function Industry Areas Geo Breakdown Clinical Trial supply 60 Pharmaceutical 50 Germany 20 Logistics 10 Biotech 10 UK 20 Clinical Project Manager 5 CRO’s 10 Belgium 10 Clinical Operations 5 Suppliers 30 France 10 Business Development and Marketing 25 Denmark 10 Austria 10 Switzerland 10 Other 10 What’s new, what’s different? • Quality: 30 boot. level speakerout of our way to ensureand smallable to listen to, and learn new speakers to high We have gone programme from large you are pharma companies and from as many, highly qualified clinical trial supply professionals as possible, giving you a prime opportunity to take home a number of new strategies and innovations to employ at your company • Seniority: Our Pre-Conference Clinicalwith no presentations. An idealDay will provide a unique, leader-to-leader, debate driven format Trial Supply Leaders Focus opportunity to discuss on a professional level with the leaders of CTS • Tailoredtostreams: Deliveringonnot onlykey initiativesforforattendees to tailor their event, but also a chance really focus down your the option 2011 “It addressed a number of key issues of relevance and had a • High levels ofweinteraction andtime for a variety oftheme that runs focused discussion conferences, have set aside networking: A key networking and through all IQPC good balance of topics. A valuable meeting.” throughout the two days including, roundtables, panels, interactive crisis management session, drinks reception and gala dinner Paul Briner, Prosidion Ltd Pharma IQ event attendee Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 9. SPONSORS AND EXHIBITORS Session Sponsor Featured Exhibitors Web: www.sca-cool-logistics.com www.zeocool.com Web: www.almacgroup.com Web: www.elpro.com Tel: +44 (0)1525 243770 Tel: +44 28 3836 2436 www.pdf-datalogger.com Fax: +44 (0)1525 243779 Fax: +44 28 3836 3800 Tel: +41 82 750 03 11 Email: cool.info@sca.com Email: clinicalservices@almacgroup.com Email: swiss@elpro.com Gold Exhibitor Web: www.movianto.com Web: www.worldcourier.com Web: www.topa.nl Tel: +49 (0)711 900 597 900 Tel: +32 2 712 50 80 Tel: +31 (0)252 245 256 Fax: +49 (0)711 900 597 910 Email: sales@worldcourier.com Fax: +31 (0)252 245 257 Email: contact@movianto.com Email: info@topa.nl “Very good mixture of different aspects, interesting case studies.” Rene Brecht, ProBioGen AG Pharma IQ event attendee Sponsorship and Exhibition Opportunities Maximise your Involvement: Sponsorship and Exhibition Opportunities Pharma IQ’s Clinical Trial Supply Europe Conference will be attended by Other features of sponsorship include: senior officials and decision-makers from industry, bringing together buyers and suppliers in one location. Focused and high-level, the event will be an • Prominent exhibition space in the main conference networking area excellent platform to initiate new business relationships. With tailored networking, • Participation in comprehensive pre-event marketing campaigns sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver. • Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirement Exhibiting and Sponsorship options are extensive, and packages can be For more information and to discuss the right opportunity, contact tailor-made to suit your individual company’s needs. Most packages include Gal Cohen on +44 (0)207 368 9300 or sponsorship@iqpc.co.uk complimentary entry passes, targeted marketing to industry officials and executives, and bespoke networking opportunities. About Pharma IQ Become a member of Pharma IQ and receive complimentary access to Resources that will keep you at the forefront of industry change. You will receive access to our growing library of multi-media presentations from industry leaders, an email newsletter updating you on new content that has been added, free aggregated news feed from over 1000 global news sources tracking your industry and special member only discounts on events. Become a member here: www.pharmaceuticaliq.com/IQLogin.aspx?IQ=pharma Media Partners Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com
  • 10. Two Day Conference: 27th-28th January 2011 Pre-Conference Focus Day: 26th January 2011 5 WAYS TO REGISTER Venue: World Trade Centre, Rotterdam, The Netherlands Freephone: 0800 652 2363 or +44 (0)20 7368 9300 To speed registration, please provide the priority code located on the mailing label or in the box below. Fax: +44 (0)20 7368 9301 My registration code is B Please contact our database manager on +44(0) 207 368 9300 or at database@iqpc.co.uk quoting the registration Post: your booking form to code above to inform us of any changes or to remove your details. IQPC Ltd. Anchor House, Register and pay Register and pay Register and pay 15-19 Britten Street, Register and pay Standard by 24th September by 8th October by 12th by 17th December Price London SW3 3QL 2010*** 2010*** November 2010*** 2010*** All Access Pass †: Option 1 Conf + 3 SAVE €1797 SAVE €1148 Contact us on +44 (0) 207 368 Online: www.clinicalsupplyeurope.com Workshops + Full Access to Conference Recordings* + Gala Dinner• €2749 +VAT €3398 +VAT 9300 or enquire@iqpc.co.uk €4546 +VAT All Access Pass †: Option 2 Conf + Fo- to check Email: enquire@iqpc.co.uk SAVE €1598 SAVE €949 cus Day + Workshop C + Full Access to availability before 8th October Conference Recordings* + Gala Dinner• €2749 +VAT €3398 +VAT €4347 +VAT Conference + Focus Day and Workshop C + Full Access to SAVE €700 SAVE €650 SAVE €600 SAVE €500 Team Discounts* Conference Recordings* + Gala Dinner• €3647 +VAT €3697 +VAT €3747 +VAT €3847 +VAT €4347 +VAT IQPC recognises the value of learning in teams. Groups of 3 or more Conference + 2 Workshops** + Full SAVE €500 SAVE €450 SAVE €400 SAVE €300 booking at the same time from the same company receive a 10% Access to Conference Recordings* + €3397 +VAT €3447 +VAT €3497 +VAT €3597 +VAT €3897 +VAT discount. 5 or more receive a 15% discount. 7 receive a 20% discount. Gala Dinner• Only one discount available per person. Conference + Focus Day + Full Access SAVE €450 SAVE €400 SAVE €350 SAVE €250 to Conference Recordings* + Gala €3698 +VAT €3248 +VAT €3298 +VAT €3348 +VAT €3448 +VAT Dinner• Conference + 1 Workshop** + Full Venue & Accommodation SAVE €400 SAVE €350 SAVE €300 SAVE €200 Access to Conference Recordings* + €2848 +VAT €2898 +VAT €2948 +VAT €3048 +VAT €3248 +VAT VENUE: Gala Dinner• World Trade Centre, Rotterdam, The Netherlands Conference + Full Access to Conference SAVE €300 SAVE €250 SAVE €200 Beurs-WTC, Beursplein 37, P Box 30099, 3001 DB ROTTERDAM .O. Recordings* + Gala Dinner• €2299 +VAT €2349 +VAT €2399 +VAT €2599 +VAT Telephone: +31 10 405 44 44, Fax: +31 10 405 50 16 Conference Only + Gala Dinner• SAVE €300 SAVE €250 SAVE €200 E-mail: info@wtcro.nl, Website: www.wtcrotterdam.nl €1749 +VAT €1799 +VAT €1849 +VAT €2049 +VAT Focus Day Only €1099 +VAT ACCOMMODATION: Accommodation is not included in the registration fee. Workshop Only** €649 +VAT For accommodation please search Book and pay by 8th October 2010 and receive an IQ Treat! Pick your treat from the options below: http://www.4cityhotels.com/rotterdam.html 6 Kindle Wireless Reading Device, Wi-Fi, 6” Display, Graphite - Latest Generation 6 New Apple iPod nano with Camera 8GB (5th Generation) – Black Free Online Resources 6 €100 Amazon Vouchers * Tick this Box if you wish to opt out of Full Access to Conference Recordings (Reducing Price by €550) 6 To claim a variety of articles, podcasts and other free resources please ** Please select choice of workshop A 6 B 6 C 6 visit www.clinicalsupplyeurope.com *** To qualify for discounts, payments must be received by the early bird registration deadline. Early booking discounts are not valid in conjunction with any other offer. Dutch VAT is charged at 19% VAT registration #: 8078 84 728 B 01 Digital Conference On CD-ROM •Tick this Box if you wish to opt out of the Gala Dinner (Reducing Price by €150) 6 † All Access Pass Limited to first 20 registrants from pharma or biotech companies before 8th October A digital version of the conference proceedings, including all presentations, is available to buy. Delegate Details 6 I cannot attend the event, please send me the CD Rom priced at Please photocopy for each additional delegate £599 plus VAT 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other Recent digital conferences available - £599 plus VAT each First Name Family Name 6 Cool Chain Europe 2010/11 6 Pharma Distribution Sept 2010 Job Title Tel No. 6 Pharmaceutical Serialisation and Traceability, November 2010 Email 6 Global Clinical Outsourcing Forum, May 2010 6 Yes I would like to receive information about products and services via email Organisation 6 Please send me conference materials indicated above. 6 I have filled out credit card details below Nature of business For further information Address Please call: 0207 368 9300 Postcode Country or email: knowledgebank@iqpc.co.uk. Telephone Fax To search IQPC’s archived conference documentation Approving Manager visit: www.iqpcknowledgebank.com Name of person completing form if different from delegate: Signature Terms and Conditions Please read the information listed below as each booking is subject to IQPC Ltd standard terms and conditions. I agree to IQPC’s cancellation, substitution and payment terms Payment Terms: Upon completion and return of the registration form full payment is required no later than 5 Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify) business days from the date of invoice. Payment of invoices by means other than by credit card, or purchase Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6 order (UK Plc and UK government bodies only) will be subject to a €65 (plus VAT) per delegate processing fee. Payment must be received prior to the conference date. We reserve the right to refuse admission to the confer- Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking. ence if payment has not been received. IQPC Cancellation, Postponement and Substitution Policy: You may substitute delegates at any time by Payment Method providing reasonable advance notice to IQPC. For any cancellations received in writing not less than eight (8) days prior to the conference, you will receive a 90% credit to be used at another IQPC conference which must occur within one year from the date of issuance Total price for your Organisation: (Add total of all individuals attending): of such credit. An administration fee of 10% of the contract fee will be retained by IQPC for all permitted cancellations. No credit will be issued for any cancellations occurring within seven (7) days (inclusive) of the Card Number: VISA 6 M/C 6 AMEX 6 conference. In the event that IQPC cancels an event for any reason, you will receive a credit for 100% of the contract fee paid. 6666666666666666 You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of cancellation. In the event that IQPC postpones an event for any reason and the delegate is unable or unwilling to attend in Exp. Date: 6 6 6 6 Sec: 6 6 6 6 on the rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit Conference code 19291.001 for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of postponement. Except as specified above, no credits will be issued for cancellations. There are no refunds given under any Name On Card: Signature: circumstances. IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postpone- ment of an event. IQPC shall assume no liability whatsoever in the event this conference is cancelled, resched- Billing Address (if different from below): uled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency. Please note that while speakers and topics were confirmed at the time of publishing, circumstances beyond the City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary without any (Please quote 19291.001 with remittance advice) liability to you whatsoever. Any substitutions or alterations will be updated on our web page as soon as possible. IQPC Bank details: HSBC Bank, 67 George Street, Richmond, Surrey, TW9 1HG. United Kingdom. Discounts All ‘Early Bird’ Discounts require payment at time of registration and before the cut-off date in order to receive Sort Code: 40 05 15, Account No: 59090618, IBAN Code: GB98 MIDL 4005 1559 0906 18 any discount. Any discounts offered whether by IQPC (including team discounts) must also require payment at the time of registration. All discount offers cannot be combined with any other offer Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd. 6 Please do not pass my information to any third party PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE