Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
15.00 	Case Study: Successfully Developing Clinical Material Resource 	
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Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.c...
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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 support global clinical trials.

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Clinical Trial Supply Europe Conference

  1. 1. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com World’s leading clinical trial supply experts will help you to: Cut overages and save money by successfully adopting S&OP processes drawn from commercial supply into a clinical setting: GlaxoSmithKline show you how they increased supply flexibility whilst positively impacting their bottom line Maintain compliance with the evolving regulatory landscape: the MHRA and Dutch Healthcare Inspectorate discuss the latest changes to Annex 13 and GDP regulations and how you can meet these requirements in your business Effectively support emerging clinical trial designs such as adaptive trials: Merck, Sharp and Dohme share their experiences of successful adaptive trials and the project team structures that deliver success Ensure product viability of temperature controlled clinical materials by establishing an effective cool chain on a global and local scale: the PDA and ActoGeniX N.V. discuss the latest strategies to ensure success on a global scale Guarantee uninterrupted supply in emerging markets such as Eastern Europe and Latin America: Galapagos NV and Merck share their most recent experiences and show you how to overcome the major hurdles www.clinicalsupplyeurope.com Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials Two Day Conference: 27th-28th January 2011 Pre-Conference Focus Day 26th January 2011 Venue: World Trade Centre, Rotterdam, The Netherlands Register and Pay Before the 24th September and Save up to €1,797! Limited to the first 20 registrants! TOP 4 reasons to attend Europe’s leading industry forum: 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 3. Exclusive to Pharma IQ: Interactive Crisis Management Session: Develop a plan of action for a particular crisis you will come face-to -face with in your work. Find out how others tackle the same challenge 4. 30 expert speakers: The largest gathering of expert clinical trial supplies speakers Clinical Trial Supply Leaders Focus Day: NO presentations, 100% peer-to-peer discussion! Interactive Specialist Discussion Forums: A: Developing a Robust and Compliant Process for Temperature Controlled Clinical Materials B: Selecting the Correct Outsourced Partners and Building the Right Relationship for Effective Vendor Management C: Innovations in Clinical Trial Supplies Labelling and Packaging See inside for more details and package discounts… “Very valuable, inspired.” Novartis AG Expert advisory panel: Tony Street, Worldwide Director Clinical Trial Supplies, Allergan Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline Juergen Rapp, Global Head, Supply Planning, Novartis Robert Smith, QP and Director, Clinical Pharmacy Research Services, Genzyme Engage with 30 industry speakers including: Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Boehringer Ingelheim Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, Lundbeck Danny Raymakers, Head of Supply Chain Management, Clinical Supply Management, Johnson & Johnson Bernadette Cunningham, Director, Pharmaceutical Operations, OSI Pharmaceuticals Trevor Knott, Associate Director Clinical Supplies, Scientific and Operational Clinical Support, Eisai Ltd Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering Pharma AG Bernd Schaden, Clinical Supply Chain Manager, Global Supply Chain, Baxter Innovations GmbH Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm Solutions & Chair, Global Clinical Supplies Group, Inc. Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp and Dohme Alfredo D’Addio, Strategic Planner, Global Investigational Material Supply Chain, Celgene Corporation see inside for more speakers… Introducing Europe’s largest and most prestigious clinical trial supply speaker panel Sponsors & Exhibitors
  2. 2. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com Clinical Trial Supply Europe Speaker Panel Tony Street, Worldwide Director Clinical Trial Supplies, Allergan Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline Juergen Rapp, Global Head, Supply Planning, Novartis Robert Smith, QP and Director, Clinical Pharmacy Research Services, Genzyme With Special Thanks To Our Executive Advisory Board: Your Distinguished Speaker Faculty Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA Amandeep Madra, Supply Chain Director, GlaxoSmithKline Juergen Rapp, Global Head Supply Planning, Novartis Alfredo D’Addio, Strategic Planner, Global Investigational Material Supply Chain, Celgene Corporation Danny Raymakers, Head of Supply Chain Management, Clinical Supply Management, Johnson & Johnson Bernadette Cunningham, Director, Pharmaceutical Operations, OSI Pharmaceuticals Trevor Knott, Associate Director Clinical Supplies, Scientific and Operational Clinical Support, Eisai Ltd Annegret Van der Aa, Clinical Trial Manager, Galapagos NV Bernd Schaden, Clinical Supply Chain Manager, Global Supply Chain, Baxter Innovations GmbH Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm Solutions & Chair, Global Clinical Supplies Group, Inc. Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp and Dohme Vivek Peshkar, Senior Drug Supply Management, Supply Planning and Design, Novartis Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk Dorthe Lerche Berg, Head Of Department, Clinical Supply Coordination, Lundbeck Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Boehringer Ingelheim Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering Pharma AG Bent Christensen, Team Leader, Clinical Trial Supply, Novo Nordisk Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma Steve Benson, Supply Chain Systems Manager, GlaxoSmithKline Lorna Briddick, Global Clinical Supplies Regional Lead, Latin America, Merck Steve Healy, Sales and Marketing Manager, SCA Cool Logistics Christian Knoblich, Commercial Director, Movianto Group Tony Moult, Proprietor, A.N. Moult Consultancy Services Sam Corveleyn, Director, CMC and QP, ActoGeniX N.V. Marianne Veighey, Team Manager, Supply Chain, Astrazeneca Dr Riekert Bruinink, Chairman, PIC/S GDP Working Group, Member of the EMEA GDP Drafting Group, Dutch Healthcare Inspectorate Justin Doel, Head, Global Clinical Supplies, Novartis Vaccines 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, Nichola Welch Senior Conference Director, Pharma IQ (a division of IQPC) “I have to say that the agenda looks really exciting with many relevant sessions that relate to our daily work” Kim Tang Hvistendal, Lifecycle Pharma A/S
  3. 3. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com PRE-CONFERENCE SPECIALIST DISCUSSIONS: Wednesday 26TH JANUARY 2011 Specialist Discussion Forum A: 09.00 – 12.00 Developing a Robust and Compliant Process for Temperature Controlled Clinical Materials In this interactive discussion you will join fellow professionals charged with supplying temperature controlled clinical materials. With the multitude of challenges that can occur when working with this type of product, it is essential that you have a clear programme in place to maintain an effective temperature controlled supply for your clinical materials. This workshop will discuss: 1. Effective assessment techniques of any logistics challenges when establishing a temperature controlled distribution to depots and clinical sites • Different ranges of conditions - deep frozen, frozen, refrigerated and other needs • Active systems • Passive systems 2. Understanding and managing risk • Rate of failure • Real product risks • Patient treatment risks • Financial risk • Administrative and inter-departmental expectation risks 3. QA for temperature sensitive materials both in transit and during storage at the clinical site • Use of temperature monitors • Obtaining data from clinical sites • Timely review of data • Handling of temperature excursions •Administrative •Minor •Major • Problem identification, elimination and process improvement 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 Specialist Discussion Forum B: 12.30 – 15.30 Innovations in Clinical Trial Supplies Labelling and Packaging In this peer-to-peer focused discussion group, attendees will explore the latest packaging and labelling technologies available and understand how these can be applied in different countries and situations. You will also discuss the latest regulatory hurdles to be aware of and how these can and do differ from country to country. Specialist Discussion Forum C: 16.30 – 19.30 Selecting the Correct Outsourced Partners and Building the Right Relationship for Effective Vendor Management In this hands-on workshop, attendees will get the chance to discuss tried and tested best practices when it comes to selecting and managing outsourced partners. It is crucial to keep these relationships working fluidly as a part of your supply chain to ensure consistent supply for clinical trials. Topics to be discussed include: • Sourcing and selection strategies that work • Building the relationship and establishing roles and responsibilities one each side • The challenges that can arise and how you can navigate past them • Case studies to work through in smaller groups Discussion Facilitator: Steven A. Jacobs, MBA, R.Ph., President, Global BioPharm Solutions and Chair, Global Clinical Supplies Group, Inc.
  4. 4. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com PRE-CONFERENCE FOCUS DAY: Wednesday 26TH JANUARY 2011 Clinical Trial Supply Leaders Focus Day: Strictly No Presentations 09.25 Pharma IQ Welcome and Chair’s Opening Remark’s 09.30 Efficiently Selecting and Managing a Global Clinical Supply Team: The Ingredients of a Successful Team • How to ensure you have the right team in place for the job in hand • Evaluating the different management structures you can adopt to manage a global network effectively • Assessing which one will work for your company Juergen Rapp, Global Head, Supply Planning, Novartis 10.20 Understanding the Behavioural Traits and Styles of Your Business Partners to Really Make The Relationship Work • What drives your business partners and how can you align this with your own goals? • Ensuring you have the correct personalities on both sides to work as one team • Negotiating other barriers such as time, culture and language Trevor Knott, Associate Director Clinical Supplies, Scientific and Operational Clinical Support, Eisai Ltd 11.10 Networking Coffee Break 11.30 Benchmarking Performance Measures for External Partners • What are the best metrics you can use to assess and compare current partners? • how this can be effectivelytranslated to enhance partner performance • Specific experience from all attendees and discussion on best practice Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline 12.20 Networking Lunch Break 13.10 Creating a Clinical Trial Supply Network to Support New Initiatives Such as Adaptive Trials • Understanding where the complications come with innovations in trial formats when supply is needed • How to ensure you have a platform ready to facilitate these trial types effectively • Sharing of specific experiences and lessons learned Danny Raymakers, Head of Supply Chain Management, Clinical Supply Management, Johnson & Johnson 14.00 Effectively Enhancing Your Distribution Practices Through Resource Pooling • Understanding the business benefits of pooling resources for distribution • The practicalities of changing your distribution to this formula: the planning process and what successful implementation looks like • Discussion of other experiences moving to a pooled resources model Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Boehringer Ingelheim 14.50 Networking Coffee Break 15.10 Successful Interface Management For Clinical Trial Supplies • Understanding the challenges that can arise with managing multiple interfaces • Where, as senior manager, can you plan for and manage this? Dr Almut Malone, Global Logistics, Clinical Supplies, Bayer Pharma AG 16.00 Close of Clinical Trial Supply Leaders Focus Day 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: 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! 1. First of all you’ll find no standard presentations, no self publicity - only complete information sharing and genuine discussion between pharmaceutical and biotechnology clinical trial supply directors 2. Each discussion is led by a different leader to reflect the different approaches to clinical trial supply across real organisations today, making it the perfect chance to compare and contrast theory in practice 3. You can submit your key challenges and requests for discussion to the group ahead of time by sending them to nichola.welch@iqpc.co.uk 4. You’ll find no sales pitches – strictly business-to-business knowledge sharing
  5. 5. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com CONFERENCE DAY ONE: THURSDAY 27TH JANUARY 2011 CASE STUDY CASE STUDY CASE STUDY 07.45 Coffee and Registration 09.00 Pharma IQ Welcome and Chair’s Opening Address Ensuring Complete Compliance With Regulatory Bodies Across Europe 09.10 Regulatory Update: Regulatory Views and Concerns for Clinical Supplies • Annex 13 then and now: how will the recent changes affect you? • Improvements to the Clinical Trials Directive and related legislation: expectations and impact • Defects, recalls and quality system problems: preparing and considering in advance Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK Reacting to a Cost Driven Environment by Effectively Building Efficiencies into Your Clinical Supply Network 09.50 Case Study: How to Establish a Demand and Operations Planning Process in the Clinical Supply Chain (using risk based forecasting and planning in a clinical trials supply chain) • The benefits of using an S&OP process drawn from a commercial supply chain in a clinical trial supply chain • Discussion of the strategy employed and the different phases of execution • The impact upon business processes, information systems and ways of working • How was the risk mitigated in this to ensure supply was not disrupted? • Managing the change process across the R&D supply chain • A case study (project example) and the lessons learned Amandeep Madra, Director, Supply Chain Logistics, GlaxoSmithKline 10.20 Successfully Adapting Proven Logistics and Distribution Models to Your Clinical Trials Supply Chain • Developing a secure strategy for temperature controlled storage and distribution • Working with 3rd parties to establish uninterrupted supply of clinical trial materials • Solutions for labelling and packaging • The importance of effective returns management in a clinical supply network • Discussion of case study examples Christian Knoblich, Commercial Director, Movianto Group 10.20 Networking Coffee Break Supporting Emerging Clinical Trial Models and Integrating Supply Chains Effectively 11.10 Case Study: Supporting Emerging Trends of Adaptive Design with Clinical Supply • Adaptive design studies and benefits to clinical development • Overcoming the challenges forecasting and simulation pose • Challenges to the clinical supply chain: design feasibility (blinding, schedule management and IVRS) • Project team structures that deliver success for adaptive designs Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp and Dohme 11.40 Case Study: Developing an Integrated Supply Chain By Implementing Supply Chain Management Frameworks • Discussion of the benefits of applying a planning framework to your clinical supplies • What different planning methods are available when looking at aspects such as quality vs. cost and waste management? • The automated systems that are available to support this Danny Raymakers, Head of Supply Chain Management, Clinical Supply Management, Johnson & Johnson 12.10 Spotlight Session This session will be dedicated to a leading service provider from within the clinical trial supply arena, offering you the opportunity to hear first-hand how the latest technology innovations could help you reach your CSM goals in 2011. 12.40 Networking Lunch Break 14.15 Interactive Roundtable Discussion This is your chance to discuss key topics and challenges in smaller groups. Attendees will be able to share their own experiences and hear those of others, exchange ideas and get clear answers to specific questions. So, in order to make the most of these interactive sessions, participants should come armed and ready to share their own experiences and have clear questions they need answers to. Choose from one of the following: A: Ensuring Clinical Trial Supplies Success in Emerging Markets Attendees will share their experience of working in emerging markets; the main challenges that arise and each person’s approach to overcoming them. Annegret Van der Aa, Clinical Trial Manager, Galapagos NV B: Ensuring Successful Temperature Controlled Supply of Clinical Materials This roundtable will focus on how to establish and manage a cool chain specifically for temperature sensitive clinical materials effectively. The pitfalls to try and avoid, the regulations to comply with and how to make this as green and cost efficient as possible. Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA C: Innovation in Packaging and Labelling This roundtable will allow attendees to discuss the key regulations within packaging and label design that must be taken into account as well as new technologies that may be able to help with challenging areas such as blind and double blind trials and adaptive trials. •Automation in packaging •Green packaging innovations Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, Lundbeck D: Successful Strategies For Working With Comparator and Global Trials When working with comparators, there is always the uncertainty or ensuring consistent supply and product quality. This roundtable will discuss how you can mitigate against the risks here and ensure the trial is never stalled on account of supply stock-out on the comparator side. Bernd Schaden, Clinical Supplies Manager, Baxter E: Maintaining Compliance with cGDP and cGCP Regulations This roundtable will allow attendees to focus not only on the regulations themselves, but also the sticking points that can sometimes leave a company vulnerable to non-compliance. How can you avoid this? Ian Holloway, Manager, Defective Medicines Centre, MHRA, UK F: Transport and Customs Challenges for Clinical Supplies This roundtable will look to discuss the challenges that arise with getting investigational materials and in and out of countries as well as looking at specific countries where this proves more of a challenge. Participants will also be asked to share their own experiences. Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair, Global Clinical Supplies Group, Inc. 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 supply network and it is always difficult to manage multiple parties to ensure complete alignment. This roundtable will focus on best practice approaches to managing this network effectively and make sure no costly slip-ups occur. Bernadette Cunningham, Director, Pharmaceutical Operations, OSI Pharmaceuticals H: Removal of Expiry Dates From Investigational Material Labels in Europe 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. This roundtable will discuss the recent experiences of those who have piloted the removal of expiry dates from labels. The lessons learned and how you can move forward in your own company. Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk I: Clinical Trial Supply for In-License Products 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 REGULATORY UPDATE
  6. 6. 15.00 Case Study: Successfully Developing Clinical Material Resource Pooling Into Your Distribution Strategy • Fully understanding the rationale behind adopting this method of storage and distribution • Highlighting the challenges that were and are being faced with the change of structure • What are the realised costs and business benefits for the venture and what are the next steps? Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Boehringer Ingelheim 15.30 Developing Temperature Controlled Packaging for Effective Distribution in Regional and Global Clinical Trials? • Innovative technology • Fit for purpose: designing packaging solutions to meet specific criteria and certain temperature ranges • Totalcostofownership:calculatingthepackagingcostperlitervolumeshipped • Assessing sustainability initiatives for today’s temperature control shipping of pharmaceuticals Steve Healy, Sales and Marketing Manager, SCA Cool Logistics 16.00 Networking Coffee Break Stream A: Ensuring Product Integrity By Designing and Executing a Successful Temperature Controlled Network for Clinical Supplies Stream Chair: Rafik H. Bishara, PhD, Technical Advisor and Chair PCCIG USA Branch, PDA Stream B: Enabling Faster Distribution By Developing a More Flexible Clinical Distribution Network Stream Chair: Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering Pharma AG 16.30 Regulatory Update: Developments in Good Distribution Practice Regulations and the Impact on Clinical Supplies • Outlining the new GDP regulations in general • Evaluating the key changes in the GDP guidelines within the EU and how these have/will affect clinical supply • Understanding any key temperature control aspects that need to be taken into consideration for cool chain products. • Implementation of revised GDP guidelines Dr Riekert Bruinink, Chairman, PIC/S GDP Working Group, Member of the EMEA GDP Drafting Group, Dutch Healthcare Inspectorate 17.00 Case Study: Successfully Developing Predominately Airborne Clinical Trial Shipping Programme • Understanding the drivers behind the use of air transport rather than land • Using airborne supply networks to reduce the risks in customs hold ups and temperature deviations • Establishing clear, accountable KPI’s with your partners to ensure high quality and timely supply Bent Christensen, Team Leader, Clinical Trial Supply, Novo Nordisk 17.30 Case Study: Managing the Interface in Distribution of Clinical Supplies See www.clinicalsupplyeurope.com for updates Dr Almut Malone, Global Logistics Clinical Supplies, Bayer Schering Pharma AG 16.30 Ensuring Compliance with Global Requirements for the Storage and Distribution of Temperature Sensitive Clinical Materials • Examining industry trends in global clinical trials and their impact on distribution chains and processes • Best practices for frozen and refrigerated shipments • Labelling and documentation for return samples to labs from international clinical trials • Effective tracking and monitoring of investigational materials • Developing a system for Good Cold Chain Management practices for clinical supplies within your company Dr Rafik H. Bishara, Technical Advisor and Chair PCCIG USA Branch, PDA 17.00 Case Study: Assessing and Selecting Sub-Contractors for Packaging, Labelling and Clinical “Cold Chain” Supply • Setting up packaging and distribution processes, KPIs and metrics with partners • Audit frequency and schedule • Deciding best practice for packaging temperature sensitive IMPs, temperature monitoring and reporting procedures • A QP point of view: temperature excursions and keeping partners accountable and IMPs safe for administration • Implementing continuous long-term improvements with partners Sam Corveleyn, Director, CMC and QP, ActoGeniX N.V. 17.30 Open Discussion: Implementing New Temperature Monitoring Processes and Technologies to Avoid Lost Investigational Materials • Discussion of the different technologies currently available • Integrating these into your current strategies • Ensuring compliance with the regulations Conference Day One Speakers and Steam A attendees are invited to join this 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! CASE STUDY CASE STUDY CASE STUDY CASE STUDY “Very valuable.” Marco Luyten, Kerry Logistics Pharma IQ event attendee Claim your free Kindle, iPod Nano or €100 Amazon Vouchers! Early Booking Treats: Book and pay by 8th October 2010 and receive an IQ Treat! Pick your treat from the options below: 1. Kindle Wireless Reading Device, Wi-Fi, 6” Display, Graphite - Latest Generation 2. New Apple iPod nano with Camera 8GB (5th Generation) – Black 3. @100 Amazon Vouchers REGULATORY UPDATE REGULATORY UPDATE
  7. 7. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com CONFERENCE DAY TWO: FRIDAY 28TH JANUARY 2011 CASE STUDY CASE STUDY CASE STUDY CASE STUDY 07.45 Coffee and Registration 08.20 Chair’s Opening Remarks Establishing Multiple Supply Networks and Moving Your Business Closer to Removing Expiry Dates from Labels in the EU Using IRT 08.30 Case Study: Let’s Start Six Global Phase III Trials in One Year! • Generating a global booklet label to support multiple clinical trials • Create a supply strategy that can supply all six trials effectively: outlining the challenges and the answers • How to program the IVRS (one massive system or multiple individual) Alfredo D’Addio, Strategic Planner, Global Investigational Material Supply Chain, Celgene Corporation 09.10 Panel Discussion: Removing Expiry Dates from CMP Labelling: The Business Benefits and the Challenges • Discussion surrounding the rationale behind moving towards the removal of expiry dates from CTM labels and what the true benefits will be • What are the perceived challenges and how do these match to the actual challenges seen by the ISPE/PDA task force? • What are the next steps to be taken by the industry to ensure this is fully adopted and realised? Panelists Include: Gary Cunnington, Global Head, Clinical Trial Supply, Respiratory, Boehringer Ingelheim Uffe Larsen, Team Leader, Clinical Supplies, Novo Nordisk 09.40 Case Study: Innovative Approaches to Increasing Efficiency by Maximising the Potential of Your Interactive Response Technology (IRT) • How to incorporate IVR and IWR systems into your current supply chain • Managing the expectations of this technology with the reality of delivery • Discussions as to how IRT data and system has helped control supply levels • Maximising benefits of systems through integration of information Steve Benson, Supply Chain Systems Director, GlaxoSmithKline 10.10 Networking Coffee Break 10.40 Interactive Crisis Management: Ensuring Your Clinical Supplies Still Make It! Unexpected challenges can arise anywhere, anytime, leaving you very little time to prepare and regroup. This dedicated, interactive session will 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 your clinical supplies arrive at their required destination with as little disturbance as possible. Group Leaders will be: A. Dorthe Lerche Berg, Head of Department, Clinical Supply Coordination, Lundbeck B. Mark Harmer, Global Clinical Supplies Operations Manager, Merck, Sharp and Dohme C. Bernadette Cunningham, Director, Pharmaceutical Operations,OSI Pharmaceuticals D. Tony Moult, Proprietor A.N. Moult Consultancy Services E: Steven A. Jacobs, President, Global BioPharm Solutions, LLC, Chair, Global Clinical Supplies Group, Inc. F: Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma G: Justin Doel, Head, Global Clinical Supplies, Novartis Vaccines 11.40 Case Study: Demand Driven Supply of IP: Creating Flexibility and Cutting Cost in an Established Clinical Supply Network • Analysis of the problems that needed to be addressed • Discussion of the strategy employed and the different phases of execution • How was the risk mitigated in this to ensure supply was not disrupted? • What are the benefits that have been seen and the lessons learned Vivek Peshkar, Senior Drug Supply Management, Supply Planning and Design, Novartis 12.40 Networking Lunch Break Effectively Planning for the Challenges that Occur When Working With Comparator Studies 13.30 Spotlight Session This session will be dedicated to a leading service provider from within the Comparator Sourcing arena, offering you the opportunity to hear first-hand the latest strategies in comparator sourcing. 14.00 Panel Discussion: Overcoming Challenges With Comparator Sourcing and Comparator Consistency for Global Clinical Trials • The benefits and drawbacks of key strategies that can help ensure consistent supply of comparators • Central vs. local sourcing: which is the right path to choose and why? • Are there factors that can change the answer? • Understanding the regulations surrounding comparator sourcing and packaging Bernd Schaden, Clinical Supplies Manager, Baxter Lorna Briddick, Global Clinical Supplies Regional Lead, Latin America, Merck Establishing a Robust Clinical Supply Network in Emerging Markets and Effectively Working with External Partners 14.30 Case Study: Planning and Executing Effective Clinical Trial Supply in Eastern European Countries: The Small Company Perspective • Outline of the rationale behind working in Eastern European Countries • Discussion of the planning phase: approach and challenges • Experience and hurdles so far? • Relationship management strategies that ensure you work with your partners as a cohesive team • What are the lessons learned? Annegret Van der Aa, Clinical Trial Manager, Galapagos NV 15.00 Networking Coffee Break 15.30 Case Study: Successful Delivery and Management of Clinical Supplies for Latin America •Latin America’s importance in the future of pharmaceutical clinical trials •Introduction of Clinical Supplies Regional Lead Role •The importance of establishing a robust supply network to support clinical trials in Latin America •Highlights of some key challenges and opportunities with Latin American countries •Discussion of specific cases and the lessons learned Lorna Briddick, Global Clinical Supply Regional Lead, Latin America, Merck 16.00 Panel Discussion: Effectively Selecting and Working With External Partners • Best practice approaches to selecting a partner • Understanding the key drivers when outsourcing on both sides as the key to creating a working partnership: how can you ensure you have all of this information? • Developing the relationship: how can you effectively develop a strong relationship with a partner and use this effectively? Annegret Van der Aa, Clinical Trial Manager, Galapagos NV Vivek Peshkar, Senior Drug Supply Management, Supply Planning and Design, Novartis Kim Tang Hvistendal, Director, Clinical Supply, LifeCycle Pharma 16.30 Chairperson’s Closing Remarks and Close of Conference Register and Pay Before the 24th September and Save up to €1,797! Limited to the first 20 registrants!
  8. 8. Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com About the event Join your peers at one of a number of networking events at Pharma IQ’s Clinical Trial Supply Europe Conference Who will be 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. Pharmaceutical 50 Biotech 10 CRO’s 10 Suppliers 30 Industry Areas Germany 20 UK 20 Belgium 10 France 10 Denmark 10 Austria 10 Switzerland 10 Other 10 Geo BreakdownJob Function Clinical Trial supply 60 Logistics 10 Clinical Project Manager 5 Clinical Operations 5 Business Development and Marketing 25 What’s new, what’s different? • Quality: 30 high level speaker programme from large and small pharma companies and new speakers to boot. We have gone out of our way to ensure you are able to listen to, and learn 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 Clinical Trial Supply Leaders Focus Day will provide a unique, leader-to-leader, debate driven format with no presentations. An ideal opportunity to discuss on a professional level with the leaders of CTS • Tailored streams: Delivering not only the option for attendees to tailor their event, but also a chance to really focus down on your key initiatives for 2011 • High levels of interaction and networking: A key theme that runs through all IQPC conferences, we have set aside time for a variety of networking and focused discussion throughout the two days including, roundtables, panels, interactive crisis management session, drinks reception and gala dinner “It addressed a number of key issues of relevance and had a good balance of topics. A valuable meeting.” Paul Briner, Prosidion Ltd Pharma IQ event attendee
  9. 9. Sponsorship and Exhibition Opportunities Maximise Your Involvement: Sponsorship and Exhibition Opportunities Pharma IQ’s Clinical Trial Supply Europe Conference will be attended by senior officials and decision-makers from industry, bringing together buyers and suppliers in one location. Focused and high-level, the event will be an excellent platform to initiate new business relationships. With tailored networking, sponsors can achieve the face-to-face contact that overcrowded trade shows cannot deliver. Exhibiting and Sponsorship options are extensive, and packages can be tailor-made to suit your individual company’s needs. Most packages include complimentary entry passes, targeted marketing to industry officials and executives, and bespoke networking opportunities. Other features of sponsorship include: • Prominent exhibition space in the main conference networking area • Participation in comprehensive pre-event marketing campaigns • Tailored marketing strategies to suit your organisation’s size, capabilities and individual requirement For more information and to discuss the right opportunity, contact Gal Cohen on +44 (0)207 368 9300 or sponsorship@iqpc.co.uk Tel: +44 (0)20 7368 9300 / 0800652 2363 Fax: +44 (0)20 7368 9301 Email: enquire@iqpc.co.uk Web: www.clinicalsupplyeurope.com Sponsors and Exhibitors Web: www.movianto.com Tel: +49 (0)711 900 597 900 Fax: +49 (0)711 900 597 910 Email: contact@movianto.com Gold Exhibitor Session Sponsor Featured Exhibitors Web: www.worldcourier.com Tel: +32 2 712 50 80 Email: sales@worldcourier.com Web: www.topa.nl Tel: +31 (0)252 245 256 Fax: +31 (0)252 245 257 Email: info@topa.nl Web: www.almacgroup.com Tel: +44 28 3836 2436 Fax: +44 28 3836 3800 Email: clinicalservices@almacgroup.com Web: www.elpro.com www.pdf-datalogger.com Tel: +41 82 750 03 11 Email: swiss@elpro.com Web: www.sca-cool-logistics.com www.zeocool.com Tel: +44 (0)1525 243770 Fax: +44 (0)1525 243779 Email: cool.info@sca.com Media Partners 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 “Very good mixture of different aspects, interesting case studies.” Rene Brecht, ProBioGen AG Pharma IQ event attendee
  10. 10. 5 WAYS TO REGISTER Freephone: 0800 652 2363 or +44 (0)20 7368 9300 Fax: +44 (0)20 7368 9301 Post: your booking form to IQPC Ltd. Anchor House, 15-19 Britten Street, London SW3 3QL Online: www.clinicalsupplyeurope.com Email: enquire@iqpc.co.uk Conferencecode19291.001 PAYMENT MUST BE RECEIVED PRIOR TO THE CONFERENCE Please read the information listed below as each booking is subject to IQPC Ltd standard terms and conditions. Payment Terms: Upon completion and return of the registration form full payment is required no later than 5 business days from the date of invoice. Payment of invoices by means other than by credit card, or purchase 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- ence if payment has not been received. IQPC Cancellation, Postponement and Substitution Policy: You may substitute delegates at any time by 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 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 conference. In the event that IQPC cancels an event for any reason, you will receive a credit for 100% of the contract fee paid. 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 on the rescheduled date, you will receive a credit for 100% of the contract fee paid. 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 postponement. Except as specified above, no credits will be issued for cancellations. There are no refunds given under any 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- 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 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 liability to you whatsoever. Any substitutions or alterations will be updated on our web page as soon as possible. Discounts All ‘Early Bird’ Discounts require payment at time of registration and before the cut-off date in order to receive 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 6 Please do not pass my information to any third party Terms and Conditions IQPC recognises the value of learning in teams. Groups of 3 or more booking at the same time from the same company receive a 10% discount. 5 or more receive a 15% discount. 7 receive a 20% discount. Only one discount available per person. Team Discounts* VENUE: World Trade Centre, Rotterdam, The Netherlands Beurs-WTC, Beursplein 37, P.O. Box 30099, 3001 DB ROTTERDAM Telephone: +31 10 405 44 44, Fax: +31 10 405 50 16 E-mail: info@wtcro.nl, Website: www.wtcrotterdam.nl ACCOMMODATION: Accommodation is not included in the registration fee. For accommodation please search http://www.4cityhotels.com/rotterdam.html Venue & Accommodation To claim a variety of articles, podcasts and other free resources please visit www.clinicalsupplyeurope.com Free Online Resources A digital version of the conference proceedings, including all presentations, is available to buy.  6 I cannot attend the event, please send me the CD Rom priced at £599 plus VAT Recent digital conferences available - £599 plus VAT each 6 Cool Chain Europe 2010/11 6 Pharma Distribution Sept 2010 6 Pharmaceutical Serialisation and Traceability, November 2010 6 Global Clinical Outsourcing Forum, May 2010 6 Please send me conference materials indicated above. 6 I have filled out credit card details below For further information Please call: 0207 368 9300 or email: knowledgebank@iqpc.co.uk. To search IQPC’s archived conference documentation visit: www.iqpcknowledgebank.com Digital Conference On CD-ROM Total price for your Organisation: (Add total of all individuals attending): Card Number: VISA 6 M/C 6 AMEX 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 Exp. Date: 6 6 6 6 Sec: 6 6 6 6 Name On Card: Signature: Billing Address (if different from below): City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) (Please quote 19291.001 with remittance advice) IQPC Bank details: HSBC Bank, 67 George Street, Richmond, Surrey, TW9 1HG. United Kingdom. Sort Code: 40 05 15, Account No: 59090618, IBAN Code: GB98 MIDL 4005 1559 0906 18 Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd. Please photocopy for each additional delegate 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other First Name Family Name Job Title Tel No. Email 6 Yes I would like to receive information about products and services via email Organisation Nature of business Address Postcode Country Telephone Fax Approving Manager Name of person completing form if different from delegate: Signature I agree to IQPC’s cancellation, substitution and payment terms Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify) Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6 Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking. Delegate Details Payment Method Book and pay by 8th October 2010 and receive an IQ Treat! Pick your treat from the options below: 6 Kindle Wireless Reading Device, Wi-Fi, 6” Display, Graphite - Latest Generation 6 New Apple iPod nano with Camera 8GB (5th Generation) – Black 6 €100 Amazon Vouchers * Tick this Box if you wish to opt out of Full Access to Conference Recordings (Reducing Price by €550) 6 ** Please select choice of workshop A 6 B 6 C 6 *** 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 •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 Two Day Conference: 27th-28th January 2011 Pre-Conference Focus Day: 26th January 2011 Venue: World Trade Centre, Rotterdam, The Netherlands Register and pay by 17th December 2010*** Standard Price Register and pay by 12th November 2010*** Contact us on +44 (0) 207 368 9300 or enquire@iqpc.co.uk to check availability before 8th October Register and pay by 8th October 2010*** Register and pay by 24th September 2010*** SAVE €1148 €3398 +VAT SAVE €949 €3398 +VAT SAVE €650 €3697 +VAT SAVE €450 €3447 +VAT SAVE €400 €3298 +VAT SAVE €350 €2898 +VAT SAVE €250 €2349 +VAT SAVE €250 €1799 +VAT SAVE €200 €1849 +VAT SAVE €600 €3747 +VAT SAVE €400 €3497 +VAT SAVE €350 €3348 +VAT SAVE €300 €2948 +VAT SAVE €200 €2399 +VAT SAVE €500 €3847 +VAT SAVE €300 €3597 +VAT SAVE €250 €3448 +VAT SAVE €200 €3048 +VAT €2599 +VAT €2049 +VAT €1099 +VAT €649 +VAT €4347 +VAT €4546 +VAT €4347 +VAT €3897 +VAT €3698 +VAT €3248 +VAT SAVE €1797 €2749 +VAT SAVE €1598 €2749 +VAT SAVE €700 €3647 +VAT SAVE €500 €3397 +VAT SAVE €450 €3248 +VAT SAVE €400 €2848 +VAT SAVE €300 €2299 +VAT SAVE €300 €1749 +VAT All Access Pass †: Option 1 Conf + 3 Workshops + Full Access to Conference Recordings* +GalaDinner• All Access Pass †: Option 2 Conf + Fo- cus Day + Workshop C + Full Access to ConferenceRecordings*+GalaDinner• Conference + Focus Day and Workshop C + Full Access to Conference Recordings* + Gala Dinner• Conference + 2 Workshops** + Full Access to Conference Recordings* + Gala Dinner• Conference + Focus Day + Full Access to Conference Recordings* + Gala Dinner• Conference + 1 Workshop** + Full Access to Conference Recordings* + Gala Dinner• Conference + Full Access to Conference Recordings* + Gala Dinner• Conference Only + Gala Dinner• Focus Day Only Workshop Only** To speed registration, please provide the priority code located on the mailing label or in the box below. 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 code above to inform us of any changes or to remove your details.

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