DAY ONE: Monday 26th February 2006
DEVELOPING GLOBAL CLINICAL TRIAL SUPPLY
09:15	Mike Dey VP Pharmaceutical Development IPSEN	Reviewing the development from national to global Clinical Trial Supply systems – moving trials to new countries and regions Understanding the basic requirements in order to consolidate multiple clinical trial sites into a global process Creating a balancing act - how do you incorporate local studies with other international studies? What are the essential skills set needed in order to successfully run a global Clinical Trial Supply system How to manage the complexity of multiple regulatory authorities, timescale and the conflicting needs and priorities
09:55	Noel Foucart Director Sales & Marketing – Europe World Courier	Identifying the particular requirements for Clinical Trial material storage and distribution in emerging 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 license requirements and customs Looking forward to China, Japan and India: predicting the future of the various Asian countries in the CTS chain – drawback and benefits
10:35		Morning refreshments
OVERVIEW OF CLINICAL TRIAL SUPPLY TECHNOLOGIES
11:05	Geert Langendries Associate Manager Covance IVRS	Minimising Drug Supply Issues during a Global Clinical Trial A ‘back to basics’ description of Covance’s chief recommendations, based on experience and observation Pre-Study Planning: early consideration of optimal packaging/labeling design, possible protocol pooling, statistical considerations, local depot strategy, enrollment control and planning for expiry dates Site supply strategy based on real recruitment information and predictions only where real information is not available Frequent monitoring of the supply status using web-based reports and alert reports for key milestone or unanticipated events Forecasting prior to study start at intervals during the study and incorporating ‘what if’ scenarios
11:45	Jerold Grupp ex-Director Global Clinical Operations Johnson & Johnson	Defining and refining the relationship between Clinical Trials, Clinical Supplies and IVRS – a US perspective Understanding the importance of finding and setting the balance between trial design, optimal packaging and IVRS Expanding the efficiency of your Clinical Supply chain by developing your packaging systems to facilitate and enhance IVRS A practical overview of IVRS strategies and techniques within the Clinical Trial Supply chain Establishing the differences between US and EU practices – what can you learn from US systems
12:25	Graham Nicholls Product Manager - Randomization & Supply Chain Management Clinphone	Adaptive trial designs: overview and implications on supply requirements Overview and current regulatory guidelines Technology solutions for implementing of adaptive trial designs Impact on trial supply management and estimating trial supply requirements
13:05		Lunch
14:15	Heike Röder Head of CTS - Planning Group Schwarz BioSciences	Drug accountability, reconciliation, returns and destruction Importance and legal aspects of return handling and accountability Balance between legal aspects and pragmatic way of return handling Using IVRS to help with accountability and complete traceability Future ideas and technologies for return handling
14:55	Jean-Remy Behaeghel Director Business Development Perceptive Informatics Ed Tourtellotte President Tourtellotte Solutions	IVRS and data collection: strategies for drug supply data collection and analysis Defining and analyzing the resulting data from your IVRS Understanding the importance of finding and setting the balance between IVRS data and CTS Expanding the efficiency of your Clinical Supply chain by developing your systems to facilitate and enhance IVRS A practical overview of IVRS strategies and techniques within the Clinical Trial Supply chain
15:35	Chédia Abdelkafi Senior Supervisor Clinical Supplies Eli Lilly	Analysing the challenges and solutions with simulation technologies over the last year Enrollment rate modelling Quality of inputs level of detail Analysing the output and making decisions Re-evaluations for ongoing trials Integration with other systems Adaptive trial designs
16:15		Afternoon refreshments
CLINICAL TRIAL SUPPLY TEAM DEVELOPMENT
16:35	Anette Bested Toft Clinical Trial Supply Advisor Nycomed	Facing the challenges in internal relationship between Clinical Trial Supply and other departments A close look at the relationship with the Medical, Analytical and Regulatory Affairs department Assessing the complications that arise when working in CTS Developing the interface between departments and clarifying any grey areas
17:15	Marc Jeurissen Clinical Trial Coordinator Organon	How to be an effective clinical supply coordinator Gathering trial information Breakdown of activities Communication and teamwork Managing changes and re-supplies Tools (KPIs and planning) Local vs. global studies In-source vs. outsource
17:55		Closing remarks from the Chair
18:00		End of Day One

DAY TWO: Tuesday 27th February 2007
		Roundtable morning Delegates will be able to attend three one-hour roundtable discussion groups from a selection of six key topics. An industry expert will facilitate each session ensuring an exchange of opinions and essential experiences related to an aspect of Clinical Trial Supply Management.
	Mike Dey VP Pharmaceutical Development Ipsen	Confronting ongoing problems in meeting multilingual label requirements for clinical trial materials
	Dario del Mazza Supply Chain Programs Director Clinical Distribution Serono	Practical analysis of how to minimize drug supplies issues during a global clinical trial
	Eva Miller Head of Biostatistics Almac Clinical Technologies	Adaptive trial design: expanding the efficiency of your CTS systems to administer flexible dosing
	Audrey Charron Medical and Drug Regulatory Affairs Drugs Supplies Manager Boehringer Ingelheim	Managing the Clinical Trial Supply system: analysing the different databases and software used to control clinical supplies
	Chédia Abdelkafi Senior Supervisor, Clinical Supplies Lilly	Simulation technologies – how to overcome the current difficulties related to integrating and controlling an efficient CTS forecasting system
	Jeroen Gerritsen Senior Global Clinical Supplies Officer Solvay	Global packaging: resolving the inevitable challenges for international distribution
	Jerry Grupp ex-Director Global Clinical Operations Johnson & Johnson	Defining and refining the relationship between Clinical Trials and Clinical Supplies
	Graham Nicholls Product Manager ClinPhone	Trial supply management strategies for complex study designs (e.g. titration studies, medication pooling, adaptive trial designs)
	Chris Pollard CEO Kryotrans	Overcoming global hurdles in maintaining the cold chain when transporting Clinical Trial supplies
12:15		Lunch
LABELLING, PACKAGING & TRANSPORT FOR CLINICAL TRIAL SUPPLY
13:30	Jeroen Gerritsen Senior Global Clinical Supplies Officer Solvay	Best practices for managing global packaging for Clinical Trials How to fulfill the complex regulatory demands concerning Clinical Trial packaging Contract packagers, dealing with comparators, setting up global distribution Industry case study: recent strategies and pre-requisites for successful flexible packaging Differences in regulations and impact on the release of medication
14:10	Jim Benkendorf Director Clinical Supplies Management Aptuit	IVRS Strategies? The Clinical Materials perspective Discuss benefits of IVRS from a Clinical Monitoring and Design vs. Clinical Material Management aspect Identify study design and site variables that are key drivers in building an effective drug supply strategy Discuss strategies for drug supply forecasting and maintenance in IVRS managed studies. Understand the importance of timing and infl uence of clinical materials representation on the IVRS design team
14:50		Afternoon refreshments
15:20	Florence Duchemin Clinical Investigation Project Manager~ Sanofi-Aventis	Packaging development: flexible packaging for Phase I Clinical Trials Considerations fro packaging production for phase I Clinical Trials Setting up a collaboration with a Phase I trial and the individual dosage units on site Determining the different regulatory issues and the packaging processes for Phase I trials Industry case study: recent strategies and pre-requisites for successful flexible packaging
16 :00	Michael Richter Global Clinical Supply Coordinator F. Hoffman La-Roche	Optimal Packaging strategies for clinical trials matching Optimal distribution Optimal compliance Effective business management in packaging department Cost effectiveness in bulk material production
16:40		Closing remarks from the Chair
16:50		End of Day Two and Champagne prize draw