David Bernstein
Vice President Pharmaceutical Sciences
and Regulatory Compliance Bernstein CMC Regulatory Consulting
Opening remarks from the Chair
Understanding and applying regulations for supplying materials for international clinical trials
09:15
Mark Rohlfing
Director of Quality Almac Clinical Services
Keynote presentation - overview of current EU regulations affecting IMP supply
Overview of the regulatory framework affecting IMP delivery in Europe
Current status and recent changes to the EU clinical trial directive
Supporting directives and guidance documents
09:55
Donna McDermott
Associate Director
Worldwide Regulatory Coordination and Clinical Supplies Merck & Co., Inc.
Case Study - importing and exporting clinical materials in and out of the EU and US
Ongoing communications with appropriate departments
Timing to be included for planning shipping of supplies
Sourcing issues for investigational drugs and comparator agents
Maintaining flexibility of supplies
Import and export process and agencies involved
10:35
Morning refreshments
11:05
René Hopfinger
Clinical Supply Manager Amgen
Synchronizing a global CTS system
Exploring the expanding clinical trial landscape
Organizing global clinical trial systems – effective project management for efficient timing and cost reductions
Harmonizing multiple sites into one global strategy
Predicting the future of clinical trials and ensuring preparation within your supply team
11:45
Nitin Pathak
Associate Research Fellow Pfizer
Case study - optimization of clinical supply manufacturing unit utilizing lean manufacturing principles
Lean manufacturing principles
Application of the principles to optimize business processes and organizational alignment
Ensuring successful outsourcing – choosing the right partner and maintaining relationships
12:25
Jennifer Bahr-Davidson Director,
Manufacturing and Clinical Supplies Avigen
Case study - outsourcing CTS functions to support an EU/Eastern European trial
Sourcing external companies and integrating players into the chain
Designing the best packaging, labeling, and distribution strategy
Managing a successful clinical supply chain through effective partner communication
1:05
Lunch
2:15
Rob Silber
Director, Supply Chain Management Fibrogen
Successfully outsourcing your clinical supply
Selecting the right Contract Manufacturing Organization (CMO)
Implementing good documentation practices with your CMO
Successfully managing your CMO
Enhancing clinical supply chain efficiency through technology
2:55
Edward Tourtellotte
President and CEO Tourtellotte Solutions
From clinical supply simulation to IWR in several minutes
IVRS legacy vs. modern web paradigm
The power of parameters (the 80%)
Limits and mitigators (the 19%)
The power of the new paradigm
3:35
Afternoon refreshments
Understanding CTS requirements for adaptive trial design
4:00
Sandy Richwalski
Vice President, Business Development Bilcare Global Clinical Supplies
Pinpointing the challenges for clinical supply teams
Mid-trial modifications such as randomization schemes and treatment arms
Aligning IVRS/IWRS solutions to the adaptive trial
Identifying the most suitable inventory strategy
Difficulties in forecasting clinical products for an adaptive trial
Supplying comparator products for clinical studies
4:40
Jim Krupa
Associate Director Planning and Coordination Cephalon
Achieving single source comparators for global studies
Highlighting the advantages of single sourcing
Complying with multi-country regulations
Successful single sourcing strategies
5:20
Closing remarks from the Chair and close of Day One
Program Day Two Thursday June 5 2008
08:30
Registration and coffee
09:00
Marisa Ehinger
Director New Products Services Almac
Opening remarks from the Chair
09:10
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 a current aspect of clinical trial supply.
1.
Ensuring successful outsourcing for CTS
Philip Chou
Senior Manager Clinical Supplies Elan Pharmaceuticals
2.
Discussing CTS simulation
Edward Tourtellotte
President and CEO Tourtellotte Solutions
3.
Understanding regulatory requirements for conducting trials within the EU
David Bernstein
Vice President, Pharmaceutical Sciences and Regulatory Compliance Bernstein CMC Regulatory Consulting
4.
Maximising IVR systems to effectively manage the clinical supply chain
Les Hanson
Group Leader Almac Clinical Technologies
5.
Sourcing and supplying comparators for clinical trials
Jim Krupa
Associate Director, Planning and Coordination Cephalon
6
Interface between Good Manufacturing Practice and Good Clinical Practice and its application in CTS
Olga Crowther
R&D QA Unit Manager AstraZeneca
7.
On-Demand - when to select this method for packaging and labeling
Gerald Finken
President CSM
8.
Discussing import/export strategies between the EU and US
Donna McDermott
Associate Director, Worldwide Regulatory Coordination and Clinical Supplies Merck & Co., Inc.
12:35
Lunch
Understanding removing bottlenecks from clinical packaging labeling and distribution
1:35
Arpad Lehoczki Manager Global Vision
How to avoid labeling errors by leveraging technology
Current challenges in the clinical trial labeling process
Using technology to overcome barriers
Case Study: Clintrak’s implementation of comparison technology
2:10
Ben Renda
Director, Clinical Supply Chain Fisher Clinical Services
Assuring product quality during clinical cold chain distribution
Setting up a clinical cold chain – regulations and requirements
Avoiding temperature deviations during transit and storage
Assessing product stability and monitoring the temperature
2:55
Gerald Finken President CSM
On-demand packaging and labeling for adaptive trials
Preparing for adaptive trails using on-demand packaging and labeling
Implementing on-demand packaging and labeling for adaptive trials
Redefining and eliminating the need to forecast CTM inventories to be packaged and labeled
Simplifying inventory strategy - refocus drug product requirements for clinical program and not protocoll
3:35
Afternoon refreshments
4:00
David Bernstein Vice President Pharmaceutical Sciences and Regulatory Compliance Bernstein CMC Regulatory Consulting
Resolving packaging and labeling issues for a multi-country trial
Outlining the challenges of a global labeling system
Dealing with individual country labeling regulations
Producing a multi-lingual label – challenges and solutions
4:40
Christine Fattore Director, Clinical Research Pharmacy Services Medimmune
Case study – packaging biotech products for clinical trials
Discussing the challenges we face for packaging biotech products for clinical trials
Assessing the available packaging options – which solution fits which product
Addressing the additional challenge for temperature sensitive products
5:20
Closing remarks from the Chair and close of day two
