Programme

Day One | Day Two

DAY 1: MONDAY 25 FEBRUARY 2008
08.30		Registration
09.00	Didier Basseras Global Senior Director, Clinical Supply SANOFI-AVENTIS	Opening remarks from the Chair
ENSURING SUCCESSFUL MANAGEMENT THROUGHOUT THE CLINICAL SUPPLY CHAIN
09:15	Frans Maris Executive Director Investigational Product Supply N.V. ORGANON	Case study – A review of four years experience in leading the global clinical supply chain at Organon Understanding the importance of communicating milestone deliverables throughout the chain process Developing a robust process for getting country specific translations in time Sharing experiences in the distribution chain - pricing of medication - dealing with overages - cold chain issues - clinical supply planning Utilising KPIs for a clinical supply chain
ESTABLISHING A GLOBAL DISTRIBUTION PROCESS FOR CLINICAL TRIAL SUPPLY (CTS)
09:55	Mark Bishop Director Sales and Marketing UK WORLD COURIER	Clinical trial material - storage and distribution in emerging countries Understanding the landscape and localisation of clinical trials and the custom challenges they pose Managing the complexity of multiple regulatory authorities – documentation and timescales Preparing and planning for border problems and shutdowns Harmonising multiple sites into one global strategy
10:35		Morning refreshments
11:05	Donna McDermott Associate Director Worldwide Regulatory Coordination Clinical Supplies MERCK	Importing and exporting clinical materials from the EU to the US Considering potential difficulties and bottlenecks in the supply chain Highlighting key FDA conditions and regulatory requirements for speed of transit Applying management techniques for effective distribution and compliance
11:45	Mark Woolfe Global Depot Manager ALMAC	Addressing the challenges of IMP depot management in emerging countries Current trends in clinical trials Specific challenges of IMP compared with commercial distribution Impact on the supply chain and potential solutions The depot selection and management process
12:15	Hansjoerg Nortmeyer Supply Chain Trial Manager SANOFI-AVENTIS	Case study - dealing with global cold chain distribution challenges for clinical trials Setting up a worldwide cool chain distribution process and complying with global regulations Defining optimal cool containers and logistic partners Avoiding temperature deviations during transport and storage Assessing the importance of stability programmes
13:05		Lunch
ADDRESSING PACKAGING AND LABELLING TECHNIQUES FOR CLINICAL TRIALS
14:15	Markus Bauss International Project Manager SCHREINER	Packaging and labelling concepts within international CTS Outlining multi-functional label solutions and services for optimised preparation and logistics of supplies Demonstrating an RFID-based temperature monitoring system by means of a case study Supporting solutions for documentation improvement and data reliability
14:55	Heike Röder Global Head of CTS Planning SCHWARZ BIOSCIENCES UCB-GROUP	Case study - implementing a clinical packaging and labelling system for trials in emerging countries Outlining the labelling challenges and needs for running global clinical trials Dealing with multi-language trials Mitigating the problems of double-blinded studies
15:35		Afternoon refreshments
16:05	Harald Hermann Life Sciences CTM Account Manager ROCKWELL AUTOMATION	Leading-edge technology for CTS RFID labelling – the status quo and future trends Increasing productivity by using vision inspection for labelling IMP packaging control via barcode or RFID Efficient data exchange for outsourcing Use of internal/external IVRS and IWRS technologies
OUTSOURCING YOUR CTS FUNCTION – BUILDING RELATIONSHIPS AND REDUCING COST
16:45	Jeroen Gerritsen Senior Global Clinical Supplies Officer SOLVAY PHARMACEUTICALS	Reducing costs through successful outsourcing Discussing the benefits of outsourcing your CTS needs Sourcing vendors and managing manufacturer/CRO partnerships Handling outsourcing in emerging countries
17:25	Frans Maris Executive Director, Investigational Product Supply N.V.	Closing remarks from the Chair
17:35		Drinks reception sponsored by ALMAC

DAY 2: TUESDAY 26 FEBRUARY 2008
8:30		Registration
9:00	Eva Miller Head of Biostatistics ALMAC	Opening remarks from the Chair
9:10	Roundtable morning	Delegates will be able to attend three one-hour roundtable discussion groups from a selection of key topics. Each session will be chaired by an industry expert who will facilitate an exchange of opinions, essential experiences and learning related to an aspect of clinical trial supply.
	Peter Konkel Director Group Leader Clinical Trial Supplies ACTELION PHARMACEUTICALS LTD	1. Organising CTS management in Phase 1 trials
	Eva Miller Head of Biostatistics ALMAC	2. Logistics and implementation of adaptive trial design
	Chris Bland Head of Drug Supply Management NOVARTIS	3. Harmonisation strategies for merging multiple sites into a global process
	David Allen CEO AD ALLEN PHARMA LIMITED	4. Discussing CTS regulatory requirements
	Claire Newcomb Principle Scientist Pharmaceutical Sciences PFIZER GLOBAL R&D	5.The interface between GCP and GMP in the supply of extemporaneous products in the Phase 1 setting
	Robyn Wood Operations Account Manager CLINPHONE	6. Trial supply management strategies for complex study designs
	Heike Röder Global Head of CTS Planning SCHWARZ BIOSCIENCES UCB-GROUP	7. Discussing clinical labelling and packaging issues for multi-country trials
	Angus Cameron Director, Senior Vice President PHARMARAMA	8. Sourcing comparators for clinical trials in Asia
	Chédia Abdelkafi Senior Consultant CT Supply Chain N-Side	9. A qualitative and quantitative approach to clinical supplies management
	Johan Verboven Senior IVR Project Manager COVANCE	10. Cradle to Grave Tracking of Investigational Products: Pre-planning for Drug Reconciliation
12:35		Lunch
FOLLOWING THE CONTINUOUS EVOLVEMENT OF TECHNOLOGIES TO MANAGE CTS
13:45	Wade Wirta Vice President of IVRS PERCEPTIVE INFORMATICS	Enabling a global seamless supply chain through IVRS/IWRS technology Review IVR/IWR capabilities to track and manage CTS supplies Enhanced utilisation of IVR and site metrics to drive JIT algorithms Integration of drug supply forecasting with IVRS/IWRS for proactive CTS management Reducing costs and risk in the supply chain through IVRS/IWRS
ADAPTIVE AND ON-DEMAND SUPPLIES FOR CLINICAL TRIALS
14:25	Mike Dey Vice President Pharmaceutical Development IPSEN	Implementing strategies for on-demand packaging, labelling and distribution The growth of adaptive trials - confronting the challenges to the supply team Pinpointing the challenges for clinical supply teams – flexible dosing and mid-trial modifications Debating potential regulations for adaptive trials – compliance and integration into the supply chain Global and multi-country supplies in real time
15:05		Afternoon refreshments
15:35	Brian Henry Executive Director Pharmaceutical Sciences PFIZER GLOBAL R&D	The use of extemporaneously prepared drug product supplies to facilitate rapid clinical evaluation in Phase I and II Clinical benefits of extemp prep supplies in the Phase I setting Process and practices to ensure high quality extemp prep products Cost and time savings compared to GMP manufactured and supplied product Use in the Phase II setting Interface between GCP and GMP
MANAGING ACCOUNTABILITY AND RECONCILIATION
16:15	Michael Herschel Director Clinical Pharmacy GLAXOSMITHKLINE	Ensuring effective drug accountability and reconciliation Understanding the importance of drug accountability for study validity Assessing the increased interest of regulators and auditors in the reconciliation process Dealing with surplus products – best practice for reducing cost
16:55	Edward Tourtellotte President & CEO TOURTELLOTTE SOLUTIONS	From clinical supply simulation to IWR in several minutes
17:35		Closing remarks from the Chair and Champagne prize draw
17:50		End of Conference