Programme

DAY ONE: TUESDAY OCTOBER 24TH 2006
08.30		Registration
09.00	Tom Cote Clinical Investigational Products Project Manager SANOFI-AVENTIS	Opening remarks from the Chair
EXISTING AND EMERGING MARKETS IN THE CLINICAL TRIAL SUPPLY CHAIN
09:15	Mike Dey VP Pharmaceutical Development IPSEN	Reviewing our development from national to global Clinical Trial Supply systems – continuously 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
09:50	Sandy Richwalski VP, General Manager, Pharmaceutical Technologies and Services CARDINAL HEALTH	Challenges of Emerging Markets (Asia & India) Why target emerging markets? Legal and regulatory requirements Country specific aspects
10:25	Morning refreshments
10:50	Fabiano Nascimbeni Clinical Operations Manager ASTRAZENECA	CTS in Latin America: how to reconcile the logistical and regulatory hurdles of this new market Getting to grips with the diversity of the Latin American region Receiving material: an insight into the local issues and logistical diffi culties and how to solve them Managing the actual clinical trial: resolving the considerable timeline issues Learn the overall benefi ts of conducting trials in Latin America and what are the future expectations
LABELING, PACKAGING AND TRANSPORT FOR INTERNATIONAL CLINICAL TRIALS
11:25	John Monetti VP Sales & Marketing WORLD COURIER Henry Ames Director, Strategic Marketing Sensitech	Cold chain management within clinical R&D transport Ensuring the integrity of your investigational product, ensuring patient safety and accurate clinical data Knowledge of route specific ambient temperature expectations (on the ground and in the air): analyzing packaging options to help support your temperature control requirements, customs clearance / regulatory requirements and temperature monitoring throughout Understanding active and passive packaging options, temperature monitoring / reporting and in transit temperature profiling Reviewing guidelines put forth by USP, Health Canada and the PDA’s Technical Report 39
12:10	Tom Cote Clinical Investigational Products Project Manager SANOFI-AVENTIS	Packaging for pediatric clinical trials with neonate and toddler patients Case studies of pediatric trials Criticality of formulation and presentation Important factors when parents must prepare and administer doses
12:45		Lunch
2:00	Jim Krupa Associate Director, Clinical Pharmacy WYETH-AYERST RESEARCH	Confronting the difficulties when sourcing and blinding comparator products How to fulfill the complex regulatory demands concerning comparator products Sourcing comparator products within short timeframes: efficiently using outside resources to help track down and blind comparators Understand the limited stability and the consequent release testing performed on the blinded comparator International use of comparators: recognizing the challenges of using non EU comparators in the EU
2:35	Jerold Grupp Director, Global Clinical Operations JOHNSON & JOHNSON	Defining and refining the relationship between Clinical Trials, Clinical Supplies and IVRS 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
3:10	Afternoon refreshments
3:35	David Stein Director Product Strategy CLINPHONE	Bringing Drug Accountability into the 21st Century An overview of the guidelines relating to the accountability, reconciliation, returns and destruction of clinical trial material Current practices and solutions available Sponsor and stakeholder views of the current practices Electronic solutions to manage the drug accountability process
CLINICAL TRIAL SUPPLY TEAM DEVELOPMENT
4:10	Andra Goldman Senior Manager, Investigational Supplies Logistics 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
4:45	Led by: Jerold Grupp Director, Global Clinical Operations JOHNSON & JOHNSON	Day one panel discussion: Speakers from the day will review the major topics, questions and debates raised throughout the presentations, share experiences and take further questions from the delegate audience.
4:45		Closing remarks from the Chair
5:00		End of day one

DAY TWO: WEDNESDAY OCTOBER 25TH 2006
8:30		Registration
9:00	Mike Dey VP Pharmaceutical Development IPSEN	Opening remarks from the Chair
	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.
	Becky Steffen Senior Clinical Supply Consultant, Investigational Drug Services TAP PHARMACEUTICAL PRODUCTS	1. Confronting ongoing problems in meeting international regulatory requirements and release for clinical trial materials
	Michael Platt Clinical Materials Manager NABI PHARMACEUTICALS	2. Importing and exporting challenges: understand and overcome the logistical and regulatory difficulties of international shipments
	Mike Dey VP Pharmaceutical Development IPSEN	3. Efficiently managing the Clinical Trial Supply chain and dealing with aggressive initiation dates
	Eddie Montoya Director, IVRS COVANCE	4. Expanding your IVR system to improve the forecasting effi ciency, contingency planning and trigger levels related to titration
	Christine Fattore Director, Clinical Research Pharmacy Services MEDIMMUNE	5. Packaging, labeling and cold chain distribution: review the latest developments to optimize international Clinical Trial Supply
	Eileen Sullivan Associate Director, Clinical Supplies ORTHO-MCNEIL JANSSEN SCIENTIFIC AFFAIRS	6. Building inter-departmental and team communication to optimize Clinical Trial Supply management
12:00		Lunch
CLINICAL TRIAL SUPPLY TECHNOLOGIES
1:15	Hans von Steiger Senior Principal Scientist, Clinical Supply Chain PFIZER	Formalizing your organization’s “informal” forecasting process Differentiating forecasting from planning The four key components of a successful forecasting process: a well defined data set mutually agreed roles and responsibilities rules for data updates a central data repository Forecasting process implementation: generating sponsorship communicating the plan gathering feedback from targets reinforcing compliance
1:50	Jean-Remy BehaegheDirector IVRS PERCEPTIVE INFORMATICS	Maximizing the use of IVRS in the Clinical Trial Supply chain: understanding its ongoing refinement and exploiting its potential Reviewing the latest potential for IVRS in optimizing your company’s distribution, inventory and site management needs and meeting CTS rules and regulations Adapting IVRS to improve the forecasting efficiency, contingency planning and understanding trigger levels related to titration Case study: practical examples and real-world use of optimizing your IVR system for CTS Developing your ongoing ROI analysis of IVRS and related systems
2:25		Afternoon refreshments
2:50	Kristen DeVito Director, Project Management, Clinical Packaging and Logistics 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
3:25	Mary Kolodij Manager Global Clinical Supplies, Schering Plough SCHERING PLOUGH	Forecasting Clinical Supplies to the internal commercial organization Challenges in consolidating study material demands from countries Management of forecast as protocols change, or are added (or removed) Evaluating a top-down model for consolidating and managing forecast
4:00	Mike Dey VP Pharmaceutical Development IPSEN	Day two panel discussion: Speakers from the day will review the major topics, questions and debates raised throughout the presentations, share experiences and take further questions from the delegate audience.
4:35		Closing remarks from the Chair
4:45		End of Conference and Champagne prize draw