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Agenda
| DAY ONE Monday, July 20, 2009 | |
| WORKSHOP | |
| 8:00 | Workshop Registration & Morning Coffee |
| 8:30 | Workshop – Tools for Exploring Regulatory Barriers and
the Impact on Sourcing Comparators David Bernstein, Ph.D., Principal Consultant, BERNSTEIN CMC REGULATORY CONSULTING |
| 10:30 | Refreshment Break & Networking Opportunity |
| 11:00 | Methods for Finding Common Ground: Balancing Supply
Concerns with Regulatory Requirements David Bernstein, Ph.D., Principal Consultant, BERNSTEIN CMC REGULATOR Y CONSULTING |
| 12:30 | Lunch for Workshop Attendees and Registration for Main Conference |
| About the Instructor: Dr. David Bernstein is a regulatory and technical consultant to several biotechnology and pharmaceutical companies and provides guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies and scale up to commercialization activities with the clinical development plan. He is the principal liaison between numerous virtual organizations and their CMC contractors. | |
| 1:30 | Chairperson’s Opening Remarks |
| 1:45 | KEYNOTE PRESENTATION Overcoming Logistical &
Regulatory Hurdles to Conduct Successful Comparative
Clinical Trials in China & India Frank J Reale, Worldwide Regulatory Coordination and Clinical Supplies, MERCK |
| 2:15 | PANEL Integrating Flexible and Efficient Global Strategies
For Sourcing Comparators Ted Maylath, Manager, Supply Chain Management, FACET BIOTECH Mark Walls, Associate Director, Clinical Operations, HUMAN GENOME SCIENCES Lekishia White, Vice President US Operations, MULTIPHARMA |
| 3:00 | Afternoon Break & Networking Opportunity |
| 3:30 | PANEL Establishing Criteria to Select Optimal Sourcing
and Supply Partners to Expedite Your Clinical Trials Micheline Marshall, Director, Clinical Pharmacy, WYETH Lisa Ortega, Manager, Investigational Supply Planning & Logistics, ALLERGAN |
| 4:00 | PANEL Single Source – Exploring Best Practices for
Finding Common Ground Between Regulatory & Supply
Concerns Frank J Reale, Worldwide Regulatory Coordination and Clinical Supplies, MERCK Joseph Saccomanno, Manager, Global Clinical Supply Planning, SCHERING PLOUGH CORPORATION David Bernstein, Ph.D., Principal Consultant, BERNSTEIN CMC REGULATOR Y CONSULTING |
| 4:45 | Chairperson’s Recap of Day One & Town Hall Q&A |
| 5:00 | End of Day One |
| DAY TWO Tuesday, July 21, 2009 | |||
| 8:00 | Morning Coffee & Networking Opportunity | ||
| 8:30 | Chairperson’s Opening Remarks | ||
| 8:45 | Keynote Presentation: Why Now? Understanding the Proliferation of Comparator Studies in the US and the “Big Picture” Impact on Clinical Trial Processes | ||
| 9:30 Interactive Roundtable Breakout Sesions | |||
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| Avoid Getting Shut Out! The above roundtable session is open to all attendees, but you must reserve your roundtable seat upon arrival at the Global Congress on Comparator Studies registration desk. Alternatively, you can reserve your spot ahead of time by sending an e-mail to imcrae@iirusa.com. | |||
| 10:30 | Refreshment Break & Networking Opportunity | ||
| 11:00 | How Safe Are Your Comparators? Explore Strategies to Optimize Comparator Security in New Markets | ||
| 11:45 | Identifying Best Practices for Sourcing Comparators in Asian Markets | ||
| 12:30 | Lunch for All Attendees | ||
| 1:30 | PANEL Identifying Tactics For Developing Flexible
Trial-Specific SOPs Between Regulatory, Supply Chain &
Manufacturing Operations Joseph Saccomanno, Manager, Global Clinical Supply Planning, SCHERING PLOUGH CORPORATION |
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| 2:45 | Paperwork Preparation: Ensuring You Secure the Required Documentation Throughout Your Global Trials to Avoid Unnecessary Delays | ||
| 3:15 | Chairperson’s Recap of GCCS 2009 | ||
| 3:30 | Global Congress on Comparator Studies Concludes | ||
DAY THREE Wednesday, July 22, 2009
| Clinical Trial Supply Chain Summit |
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| 7:30 | Registration & Morning Coffee |
| 8:15 | Chairperson’s Opening Remarks |
| 8:30 | Discover How to Best Utilize IVR Technology and Fully Maximize the
Potential for Managing Your Supply Materials Scott Wong, IVRS Senior Specialist, CELGENE |
| 9:15 | The Purdue Pharma Case Study: Highlighting the Role of
RFID as an Essential Tool in Your Supply Chain Strategy and
Identifying the Key Steps to Successful Implementation Mike Celentano, Associate Director Supply Chain Systems, PURDUE |
| 10:00 | Morning Refreshment Break & Networking Opportunity |
| 10:30 | Developing Tactics For Interconnecting Your Supply Chain
Technologies to Ensure Maximum Automation Lisa Ortega, Manager, Investigational Supply Planning & Logistics, ALLERGAN |
| 11:15 | Making the Most Out of Your Supply – Establishing Optimal
Strategies for Multi-national Trials & Handling Production
Failures Justine Swinney, Distribution Project Manager, Global Clinical Supplies, SCHERING PLOUGH CORPORATION |
| 12:00 | Lunch |
| 1:15 | Market By Market: Exploring Regulatory Quality and
Supply Chain Requirements & Identifying Hidden
Challenges When Conducting Clinical Trials Overseas Moderators: Beatrice Ongige, Manager, Investigational Materials, CELGENE CORPORATION Lisa Ortega, Manager, Investigational Supply Planning & Logistics, ALLERGAN |
| 2:00 | Exploring Efficient Strategies For Planning & Forecasting
Your Clinical Trial Supply Chain Operations Ted Maylath, Manager, Supply Chain Management, FACET BIOTECH |
| 2:45 | Improving Your Supply Chain Efficiencies & Traceability By Implementing an Effective ERP System |
| 3:15 | Chair Wrap Up Session |
| 3:30 | Clinical Trial Supply Chain Focus Summit Concludes |
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