Conference Day One: Tuesday, December 8, 2009

7:30 Registration And Coffee

8:15 Welcome Address And Chairperson’s Opening Remarks

Dick Winokur
Vice President, Clinical Supply Chain
Sanofi-Aventis

Optimizing Your Clinical Supply Chain

8:30 Opening Keynote: Overcoming Key Inefficiencies Within Your Clinical Supply Chain

  • Pinpointing issues which are delaying your supply chain
  • Discussing the ideology of implementing lean principals within your clinical supply chain, without increasing cost or damaging quality
  • Learning from examples: An overview of a successfully modified clinical supply chain while displaying overcoming successful inadequacies within the original processes
  • Examining the options of working with a partner to speed up supply chain optimization

Dick Winokur
Vice President, Clinical Supply Chain
Sanofi-Aventis

9:15 Developing An Integrated Clinical Trials Supply Chain

  • Identifying the drivers for integration
  • Understanding the challenges to integration and their inter-relationships
  • How GSK is implementing five core disciplines for strategic supply chain management
  • Evaluating and managing risk versus cost

Linda Nichols
Demand Logistics Manager, Pharmaceutical Development, R&D
GlaxoSmithKline

10:00 Morning Networking Break

10:45 Optimal Planning For Clinical Supply

  • Presenting techniques based on optimization approaches to align production and delivery schedule
  • Optimizing warehouse and site storage inventory level, shipment size, and minimize wastage of clinical materials
  • Addressing the challenges of clinical trials supply chain planning
  • Understanding factors affecting complexity of supply chain planning
  • Analysis of current approaches – simulation and optimization)
  • Technique for optimal clinical trial supply chain planning

Vladimir Shnaydman
President
ORBee Consulting

11:30 Panel Discussion: Analyzing Clinical Supplies Vendor Market: Choosing A Preferred Vendor Organization And Effective

  • Examining effective approaches for vendor selection and management as well as achieving senior management buy-ins for vendor suggestions
  • Understanding and reviewing the scientific background and capabilities of tentative vendor organizations - Compiling a data set in order to rank and risk assess potential vendor organizations
  • Assessing a vendor organization’s global reach with regards to clinical manufacture, supply channels, quality/regulatory requirements
  • Evaluating your proposed clinical supply vendor’s necessary facility, equipment and personnel infrastructure
  • Effective relationship management with technology providers
  • Aligning new technologies project teams to existing standards

Panelists:

Robert E. Holman
Global Account Manager, Technology
AstraZeneca

Linda Nichols
Demand Logistics Manager, Pharmaceutical Development, R&D
GlaxoSmithKline

Mark Walls
Director, Clinical Pharmacy
Human Genome Sciences

Patrick Newingham
Senior Manager, Clinical Research Pharmacy Services
MedImmune

12:15 Networking Luncheon

1:15 Developing And Maintaining A Successful And Safe Vendor Relationship For Your Clinical Supplies

  • Understanding strategic risk-management approach tools for vendor selection and management
  • Identifying and negotiating clear agreements to avoid pitfalls
  • Establishing a personal relationship with your vendor for a unified approach
  • Aligning a mutually-agreeable approach for both parties
  • Discussing techniques for successful contract re-negotiation

Spencer Comtois
Manager, Vendor Relations, Clinical Supply Chain
Schering Plough

2:00 Meeting US Security Standards And Qualifying For The TSA Screening Program To Avoid Custom Delays

  • Program background, motivations and looming deadlines
  • How to prove Chain of Custody: Documentation, application, ad authentication
  • Case studies of biopharma company compliance
  • Freight forwarders qualification requirements

Gary E. Lupinacci
Assistant Branch Chief Certified Cargo Screening Program, TSA/TSNM
Department of Homeland Security

2:45 Afternoon Networking Break

Investigating the Global Clinical Trials Regulatory Landscape

3:30 Complying With US Standards Regarding Customs Issues For Importing Clinical Supplies

  • An overview of US importing and exporting shipping requirements
  • Considering key pointers to ensure smooth logistic and distribution processes
  • Meeting US standards and qualifying for the TSA screening program to avoid customs delays
  • Understanding how to avoid detention of investigational material when importing to the USA
  • Examining successful and unsuccessful case study examples of biopharma company compliance

Panelists:

Robert Drobish
Assistant Port Director, Trade Operations, Philadelphia, Customs and Border Protection
Department of Homeland Security

Sammi Hadden
Director, Import Operations & Policy
FDA

4:15 Automated Clinical Trial Labeling Systems And Compliance With FDA 21 CFR Part 11

  • Examining automated clinical trial supply labeling techniques used to improve efficiency and data integrity for randomized clinical trials
  • Evaluating the use of computers in the clinical trial supply labeling, inventory management, and disposition
  • Understanding the FDA requirements for compliance and scope of application of 21 CFR Part 11 as applied to your current systems

Denise I. Webber
President & Founder, Clinical and Regulatory Operations
D.I.Webber Consulting, LLC

5:00 Defining Import And Export Regulations, Procedures And Strategies To Run Successful Global Clinical Studies

  • Outlining different global import and export requirements to prevent the oversight of key necessities
  • Complying with import and export rules to ensure the smooth running of global clinical trials and on-time distribution
  • Emphasizing the need of standardized global import and export requirements to facilitate compliance
  • Forecasting lead times to ensure accurate planning and to guarantee the smooth operation of global trials
  • Outlining European shipping requirements to ensure efficient logistic and distribution processes
  • Considering shipping times and delays for efficient forecasting of delivers and clinical trial running times

Jessica Sonevytsky
Senior Regulatory Coordinator
Merck & Co.

5:45 Chairpersons Closing Remarks And End Of Day One

[ Register Now ]