Clinical Trial Supply Europe 2006

Venue l Registration

Programme

Day One | Day Two

Agenda
DAY ONE: TUESDAY 28th FEBRUARY 2006
08:30		Registration and coffee
09:00	Anthony Frankland Clinical Supplies Director FISHER CLINICAL SERVICES	Opening remarks from the Chair
INDUSTRY AND REGULATORY UPDATE
09:10	Dr. Brian B. O’Neill Global Head CQA External Alliances F-HOFFMAN-LA ROCHE	Transposition of EU Clinical Trials Directives into local member state law – challenges at the GCP/GMP interface Overview of relevant European Regulatory Framework and its implications for conducting clinical studies in EU member states Managing the movement, control, and release of investigational medicinal product (IMP) into and within Europe Role of the QP(s) and the importance of formalised agreements related to breakdown of responsibilities between centralised QP, national QPs, heads of local QA and responsible persons, and between sponsor and third party contractors acting on their behalf Identifying and agreeing responsibilities at the GCP-GMP interface Need for proper communication among all responsible for the integrity of product – tracking, and control of IMP throughout the distribution chain up to final destruction of unused product
LABELLING, LOGISTICS AND SUPPLY MANAGEMENT
09:45	Esther Sadler-Williams Director Sales Europe/Asia APTUIT	CTL Contractors – do we measure up? Outsourcing models in Clinical Trial Logistics Is this a ‘partnership’ or a ‘master- slave’ relationship? Analysing the available methods of measurement A close look at the Aptuit experience
10:20		Morning refreshments
10:45	Lone Rahbek Section Leader Clinical Trial Supply H. LUNDBECK	Understanding the clinical trial supply needs for Phase I clinical trials Considerations when coordinating phase I trial supplies Setting up the collaboration with a phase I CRO for preparation of IMP into individual dosage units on site Determining the different roles of the QP’s involvement in the supply process
11:20	Kathy McLaughlin Associate Director IVRS COVANCE	Minimising drug supply issues during a global clinical trial Strategic design of drug pack size and labelling prior to packaging Strategic use of local depots Planning for the extension of expiry dates (re-labelling) and for the replacement of expiring drug during the study Maintaining the site and local depot re-supply chain Forecasting overall supply needs for the duration of the study (including 'what if' scenarios) Things always go wrong despite best laid plans - what to do then
11:55	Jane Pickering Associate Director Clinical Trial Materials ELAN PHARMA	Confronting ongoing problems in meeting multilingual label requirements for clinical trial materials Examining the range of different interpretations of the labelling guidelines across the EU Ensuring correct design and production of multilingual labels according to local and EU guidelines How to successfully source regulatory review and approval of texts and keep within timelines and deadlines Using a web-based system for approvals: is it a logical progression for quickly, securely, and conveniently obtaining clinical trial label approvals?
12:30		Lunch for delegates and speakers
EXPLOITING OPPORTUNITIES FOR EMERGING MARKETS IN THE CLINICAL TRIAL SUPPLY CHAIN
13:45	Alberto Fernandez Regional Clinical Research Director Central & Eastern Europe ASTRAZENECA HUNGARY	Understanding the basic requirements to facilitate CTS: a CEE perspective Clarifying the practical issues and impact of the Clinical Trial Directive on Eastern European countries Receiving material: an insight into the local issues and logistical difficulties and how to overcome them Looking into the future: what can we expect?
14:20	Anthony Frankland Clinical Supplies Director FISHER CLINICAL SERVICES	Emerging issues and solutions in clinical trial supply Global trials and challenges in the supply chain Analysing the criteria for success in clinical supply management Assessing and enabling the available technologies A look at supply chain integration
14:55		Afternoon refreshments
15:20	Christoph Moeschli Head Clinical Packaging Drug Supply Management NOVARTIS PHARMA	Emerging Asian markets: how to successfully conduct clinical trials in non-EU countries Overcoming the obstacles such as the lack of infrastructure, climate problems, and distribution challenges Logistical hurdles in distant foreign countries: managing labelling, on-site transport and local depots Analysis of the legal and regulatory requirements such as import licence requirements and customs Looking forward to China: predicting the future of China in the CTS chain – drawbacks and benefits
15:55	Fabiano Nascimbeni Clinical Operations Manager - CRR LatAm ASTRAZENECA LATIN AMERICA	Latin America: basic CTS principles to successful delivery of clinical trials Latin America: a diverse region - review of CTS requirements Clinical trial management - the challenge of timelines Future expectations and overall benefits
16:30		Closing Remarks from the Chair
16:45		End of Day One
17:00		Drinks Reception Delegates are invited to join the speakers, sponsors & exhibitors at an informal drinks reception
Day One \| Day Two
DAY TWO: WEDNESDAY MARCH 1ST 2005
08.30		Registration and coffee
MANAGING YOUR CONTRACTORS & SERVICE PROVIDERS ACROSS THE SUPPLY CHAIN
09:10	Mike Dey VP Pharmaceutical Development IPSEN	Meeting global distribution challenges: working with global and local contractors Determining your needs when organising CTS Establishing a set of operational procedures within your organisation and with your local or global contractor Understanding and exploiting your contractors’ strengths Keeping control and reliance on foreign service providers – how to manage problems and communication
09:45	Jean-Remy Behaegal Director IVRS PERCEPTIVE INFORMATICS	Improving the efficiency of your CTS demand and forecasting techniques and strategy A retrospective: assessing the accuracy companies expect in forecasting CTS operations Identifying the KPIs to control and adapt the targets and forecasts Reviewing examples where things have gone wrong: what kind of issues may result in your prediction proving inaccurate and how to solve them Understanding ways to integrate your electronic management solutions to create a very powerful single source platform
10:20		Morning Tea & Coffee
10:45	Claude Ammann Director Quality Assurance / Quality Control APOXIS	Case study: building the relationship between you and your CRO Determining your needs when organising CTS Choosing the contractor that can fulfil your needs Establishing a winning collaboration – the importance of communication Keeping control and reliance on foreign service providers – how to manage problems
CLINICAL TRIAL SUPPLY TECHNOLOGIES
11:20	Graham Nicholls Product Manager - Randomization & Supply Chain Management CLINPHONE	Case study: using IVR (Interactive Voice Response) technology to reduce clinical supply waste in titration clinical trials Dose titration clinical trials: where clinicians are allowed to individualise a patient’s dosage or medication regimen based on efficacy or side effects at the time of the patient visit Understanding the difficulties of managing dose titration clinical trials from a supply chain perspective Managing the unpredictability of actual CTM requirements under ‘normal’ circumstances and when there are limited supplies Two case studies describing the real-world use of IVRS to manage limited CTM
11:55	Asaf Aloni Team Leader CSU TEVA PHARMACEUTICALS INDUSTRIES	Coordinating operational activities: how to integrate your contractors in the CTS chain Understanding the building of a relationship and partnerships with contractors and service providers Re-evaluating your current techniques and systems in order to improve communication and meet deadlines Establishing structures within the organisation: managing and co-ordinating activities between the CTS chain and outsourced activities and functions How to consolidate manufacturing and packaging into a single system for subsequent data analysis
12:30		Lunch for delegates and speakers
13:45	Martin Dittmer Life Sciences Solution Architect ROCKWELL AUTOMATION	Managing clinical trial supply through simulation technologies Optimisation of the clinical supply chain with the help of simulation How the simulation tools can cover the packaging, inventory, and distribution channels Ensuring material availability and optimizing batch and shipping size Learn how to lower the overall costs of the clinical supply chain through the latest simulation technologies
14:20	Gunther Busam Head Supply Team 3 Drug Supply Management NOVARTIS PHARMA	Big Pharma case study: analysing the cutting edge clinical supply planning and forecasting tools Identification of the key drivers for developing new, innovative approaches for clinical supply planning Learn about the simulation based approach of supply planning and forecasting for complex clinical trials on case studies Understand the benefits and limitations using simulations for tailoring the clinical supply chain
14:55		Afternoon Tea and Coffee
15:20	Chédia Abdekkafi Senior Supervisor & CT Supply Management Consultant LILLY CLINICAL OPERATIONS	Optimising the CT Supply Chain - A qualitative and quantitative approach What are the CT supply chain management challenges for CT supply coordinators and the objectives of CT supply chain optimisation? A qualitative approach: analysing the impact of study parameters on packaging/labelling design, distribution network, CT material overage and IVRS inventory management strategy A quantitative approach to automate calculations and understand the variability related to a clinical trial: Deterministic model: average CT material demand over time Stochastic model: Statistical simulation to evaluate the impact of different supply plans and distribution strategies on risk/cost Re-evaluations for ongoing studies using IVRS data. What is the impact on the CT supply coordinator role?
16:20	Chioma Nwoko Clinical Supplies Project Coordinator – Europe CHIRON	Initiating and executing a clinical supply chain management improvement program Identifying our current challenges to ensure the accurate and timely supply of materials for clinical trials at Chiron Lessons learnt from process mapping our previous systems Examining the decision-making involved, steps taken and elements that were focused on when developing the improvement program Outlining the challenges ahead and the expected benefits of the programme
16:55		Closing remarks from the Chair & Champagne prize draw
17:00		End of conference

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