The 2013 Global Clinical Supplies Group Conference Preliminary Workshops
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| Update on Just-In-Time Labeling | •Identify at least two countries that will accept JIT labeling •Explain why JIT labeling may be an option •Compile a list of quality requirements for JIT labeling |
| Relabeling at Clinical Sites: Do’s and Don’ts | •Identify at least one circumstance where re-labeling at the site might be appropriate •Compile a list of quality requirements for re-labeling at the site •Compare and contrast the economics of site re-labeling vs. alternatives |
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The Power of Visual Thinking |
• (Re)Discover their power to generate, derive and communicate meaning through pictures• Learn how to rapidly and powerfully apply tools for describing and communicating concepts• Apply visual thinking techniques to actual problem situations |
| Using Forecasting Tools to Improve Investigational Product Management | •Explain the cost benefit of forecasting tools •List at least two metrics used to measure drug management •Explain where to get the the data to input into the forecasting tool |
| IRT (Interactive Response Technology) Management of Expiry Dates: Validation and UAT (User Acceptance Testing) | Define at least two key minimum requirements for IRT validation •Describe the requirements for UAT test scripts used to manage expiry management •Give examples of good relationships between sponsor companies and IRT companies •Breakdown the time requirements for IRT validation |
| Issues and Challenges of Shelf-Life Extension of Biologic Products | •Identify how shelf-life extensions for biologics differ from small molecule •Describe no fewer than two issues in extending biologics in global trials •Describe methods for managing shelf-life extensions for biologics |
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Comparator Sourcing: Does Your Comparator Have a Pedigree? |
•Identify the shortage of drug issues and their impact on clinical studies |
| Techniques and Challenges in Blinding Biologic Products | •Describe the latest blinding techniques for biologics •Give examples of three blinding techniques for biologics •Define why blinding of biologics is important |
| Handling IMP Temperature Excursions | •Give no fewer than 2 examples of recent temperature excursions and the remediation done •Explain how to ensure that clinical sites are appropriately monitoring temperatures •Compare and contrast shipping excursion vs. storage excursions •Managing excursions for comparators |
| Coaching and Mentoring to Improve Performance |
•Identify at least two coaching techniques that improve performance |
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Techniques and Challenges in Blinding Oral Solid Dosage Forms |
•Describe the latest blinding techniques for OSDs •Give examples of three blinding techniques for OSDs •Define why blinding of OSDs is important |
| Global Distribution Challenges: Depot Set-Up | •Compile a list of at least three countries that require depots •Summarize the challenges of depot set-up in at least three countries •Determine the requirements of going with a third-party depot when no primary depot is available |
| Investigational Devices (Everything You Always Wanted to Know About Devices But Were Afraid to Ask!) | •Compare and contrast the challenges of packaging devices vs. traditional clinical supplies •Differentiate the regulatory requirements for devices vs. traditional clinical supplies •Explain no fewer than 2 challenges for the import/export of devices |
| Returns, Accountability, and Destruction | •Give examples of accountability levels that differ from company to company •Identify issues with returns and destruction from overseas clinical sites •Compare and contrast on-site destruction vs. central destruction |
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Country-Specific Labeling Requirements: Update |
•Identify the label requirements of no fewer than four countries |
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