Day 1 : Sunday, April 26
Clinical Supplies 101 (Boot Camp)
Learning Objectives:
● Describe no fewer than three (3) historical events that drove the development of GMPs.
● Identify no fewer than three (3) quality rules to ensure IMP production meets global regulatory standards.
● List three (3) regulatory/quality requirements when shipping temperature controlled IMPs.
● Explain how stability studies generate shelf life dating
● Identify the greatest challenge of the new Clinical Trial Regulation and how it will effect Clinical Supplies.
● List no fewer than two (2) key requirements to developing good IMP SOPs.
Speakers:
Day 2 : Monday, April 27
Advanced Planning and Forecasting Tools - 501
Learning Objectives:
● Explain the cost benefit of forecasting tools, especially in multi-protocol drug development programs.
● Describe at least two (2) complex IMP management scenarios which would benefit from advanced forecasting techniques.
● List at least two (2) metrics used to measure IMP management.
Speakers:
Biosimilars and Biobetters: More than Generic Biologicals
Learning Objectives:
● Define biosimilars and biobetters.
● Identify at least two (2) key differences in the development of biosimilars/ biobetters compared to the innovator product.
● List at least two (2) challenges to clinical supplies for studies supporting biosimilar/ biobetter development
Speakers:
Introduction to Returns and Reconciliation - 101
Learning Objectives:
● Explain the regulatory basis for the returns and reconciliation process.
● Outline the important elements of IMP reconciliation at clinical sites.
● Diagram the flow of product from clinical supplies distribution center through receipt at a returns collection center, and indicate appropriate points of reconciliation.
Speakers:
Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage
Learning Objectives:
● Explain the importance of tracking time-out-of-environment for cold chain investigational products.
● Describe at least two (2) types of stability studies that support investigational product time-out-of-environment.
● List at least two (2) challenges to tracking time-out-of environment for cold chain products.
Speakers:
QP Update: The New Clinical Trials Regulation and IMPs
Learning Objectives:
● Summarize the impact of the new EU Clinical Trials Regulation on IMPs.
● Outline the changes to the Clinical Trial Application process resulting from the new Clinical Trials Regulation.
● Compare and contrast the QP release process versus QA release.
Speakers:
Recalling IMPs: Do You Know Where Your Drug Is?
Learning Objectives:
● List at least two (2) reasons to recall investigational products.
● Justify a mock recall procedure.
● Compare and contrast the recall of investigational product versus commercial product.
Speakers:
Strategic Tools to Shorten Timelines for IMP Availability
Learning Objectives:
● Give examples of at least two (2) strategies to shorten IMP production timelines.
● Explain the importance of building IMP vendor-partner relations and communication to improve speed and quality.
● Give at least one (1) example of how to successfully shorten production timelines using available industry tools.
Speakers:
Taking the Fear out of Regulatory Audits
Learning Objectives:
● Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.
● List three (3) key areas of focus when preparing for a regulatory audit.
● List two (2) benefits of conducting a self-audit.
Speakers:
Technologies to Improve Patient Compliance with IMP
Learning Objectives:
● Explain the impact of poor patient compliance with IMP on clinical studies.
● Give at least three (3) examples of technologies that can improve patient compliance.
● Describe the cost-benefits of compliance technologies to gain operational support for such initiatives.
Speakers:
When Things Go Wrong: Case Studies of Clinical Supply Errors and How to Prevent Them
Learning Objectives:
● Give at least three (3) examples in the clinical supply chain which require attention to avoid disastrous errors.
● Identify at least three (3) strategies to reduce the risks associated with preparing blinded clinical trial medication.
● Identify at least three (3) strategies to reduce the risks associated with shipping cold chain IMP.
Speakers:
Clinical Material Challenges for Devices and Drug/Device Combinations
Learning Objectives:
● Compare and contrast the challenges presented by packaging devices or drug/device combinations versus traditional IMP.
● Differentiate the regulatory requirements for devices or drug/device combinations versus traditional IMP.
● Give examples of at least two (2) challenges involved in the import/export of devices or drug/device combinations compared to traditional IMP.
Speakers:
Enhanced IMP Training Using Mock Kits ("Demo Kits")
Learning Objectives:
● Give at least two (2) scenarios where mock kits can enhance training.
● Describe the preparation and control procedures for mock kits compared to clinical supplies.
● List the site personnel most likely to benefit from the use of demo kits for training.
Speakers:
Issues and Challenges with Biologic IMP and Comparators
Learning Objectives:
● Compare and contrast challenges between large and small molecule IMP programs.
● List at least two (2) handling concerns specific to biologic/ large molecule IMPs.
● Give examples of at least two (2) challenges to conducting global studies with biologic IMP or comparators
Speakers:
Management of Ancillary Supplies used in Clinical Trials
Learning Objectives:
● Give at least two (2) examples of the benefits of managing ancillary supplies along with IMP.
● Evaluate at least two (2) different strategies for providing ancillary supplies to clinical study sites
● Describe at least two (2) unique challenges associated with management of ancillary supplies compared to IMP.
Speakers:
Managing the Devastating Physical and Mental Effects of the Stress of Clinical Supplies
Learning Objectives:
● List at least three (3) physically and psychologically detrimental effects of stress.
● Describe four (4) things to do to decrease stress to better cope with the pressures of clinical supplies.
● Give examples of at least three (3) ways to enhance work-life balance.
Speakers:
Opportunities to Enhance Patients' Site Experience with IMP
Learning Objectives:
● Give at least two (2) examples of poorly designed or labeled investigational product and how they could have been improved.
● Identify at least three (3) techniques for packaging or labeling investigational supplies that can enhance patient compliance.
● Explain the potential negative impact of poor experiences with IMP.
Speakers:
Technologies to Improve Patient Compliance with IMP
Learning Objectives:
● Explain the impact of poor patient compliance with IMP on clinical studies.
● Give at least three (3) examples of technologies that can improve patient compliance.
● Describe the cost-benefits of compliance technologies to gain operational support for such initiatives.
Speakers:
Update on Expiry Date Management
Learning Objectives:
● Identify information / documentation that has been critical in both educating and influencing regulators to accept removal of expiry dates from investigational product labels.
● Give examples of at least two (2) activities that will prevent use of expired medication if the expiry date is not printed on the label.
● Explain the potential impact of the new EU Clinical Trials Regulation on efforts to remove expiry dates from IMP labeling.
Speakers:
Using Key Performance Indicators (KPI) and Metrics to Improve Your Efficiency
Learning Objectives:
● Give at least two (2) examples of metrics that can be used to monitor performance in the clinical supply chain.
● Compare and contrast the use of KPIs for internal and outsourced activities.
● List at least three (3) ways KPIs/metrics can be communicated to stakeholders.
Speakers:
Using SharePoint to Improve IMP Management and Communication
Learning Objectives:
● Give examples of at least two (2) challenges to implementing cloud-based systems in a GMP environment.
● List at least two (2) benefits to IMP management incurred by using SharePoint.
● Define cloud-based storage, portal, computer system validation.
Speakers:
Advanced Planning and Forecasting Tools - 501
Learning Objectives:
● Explain the cost benefit of forecasting tools, especially in multi-protocol drug development programs.
● Describe at least two (2) complex IMP management scenarios which would benefit from advanced forecasting techniques.
● List at least two (2) metrics used to measure IMP management.
Speakers:
Issues and Challenges with Biologic IMP and Comparators
Learning Objectives:
● Compare and contrast challenges between large and small molecule IMP programs.
● List at least two (2) handling concerns specific to biologic/ large molecule IMPs.
● Give examples of at least two (2) challenges to conducting global studies with biologic IMP or comparators
Speakers:
Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage
Learning Objectives:
● Explain the importance of tracking time-out-of-environment for cold chain investigational products.
● Describe at least two (2) types of stability studies that support investigational product time-out-of-environment.
● List at least two (2) challenges to tracking time-out-of environment for cold chain products.
Speakers:
Packaging Innovations: Enhance Your IMP Design
Learning Objectives:
● Give at least two (2) examples of recent innovations in packaging designs specific for IMP.
● Explain the benefits of innovative packaging designs to the conduct of clinical trials.
● Compare and contrast innovative packaging techniques with traditional bottles and wallets
Speakers:
QP Update: The New Clinical Trials Regulation and IMPs
Learning Objectives:
● Summarize the impact of the new EU Clinical Trials Regulation on IMPs.
● Outline the changes to the Clinical Trial Application process resulting from the new Clinical Trials Regulation.
● Compare and contrast the QP release process versus QA release.
Speakers:
Recalling IMPs: Do You Know Where Your Drug Is?
Learning Objectives:
● List at least two (2) reasons to recall investigational products.
● Justify a mock recall procedure.
● Compare and contrast the recall of investigational product versus commercial product.
Speakers:
Taking the Fear out of Regulatory Audits
Learning Objectives:
● Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.
● List three (3) key areas of focus when preparing for a regulatory audit.
● List two (2) benefits of conducting a self-audit.
Speakers:
Update on Expiry Date Management
Learning Objectives:
● Identify information / documentation that has been critical in both educating and influencing regulators to accept removal of expiry dates from investigational product labels.
● Give examples of at least two (2) activities that will prevent use of expired medication if the expiry date is not printed on the label.
● Explain the potential impact of the new EU Clinical Trials Regulation on efforts to remove expiry dates from IMP labeling.
Speakers:
Using SharePoint to Improve IMP Management and Communication
Learning Objectives:
● Give examples of at least two (2) challenges to implementing cloud-based systems in a GMP environment.
● List at least two (2) benefits to IMP management incurred by using SharePoint.
● Define cloud-based storage, portal, computer system validation.
Speakers:
Day 3 : Tuesday, April 28
Advanced Planning and Forecasting Tools - 501
Learning Objectives:
● Explain the cost benefit of forecasting tools, especially in multi-protocol drug development programs.
● Describe at least two (2) complex IMP management scenarios which would benefit from advanced forecasting techniques.
● List at least two (2) metrics used to measure IMP management.
Speakers:
Biosimilars and Biobetters: More than Generic Biologicals
Learning Objectives:
● Define biosimilars and biobetters.
● Identify at least two (2) key differences in the development of biosimilars/ biobetters compared to the innovator product.
● List at least two (2) challenges to clinical supplies for studies supporting biosimilar/ biobetter development
Speakers:
Management of Ancillary Supplies used in Clinical Trials
Learning Objectives:
● Give at least two (2) examples of the benefits of managing ancillary supplies along with IMP.
● Evaluate at least two (2) different strategies for providing ancillary supplies to clinical study sites
● Describe at least two (2) unique challenges associated with management of ancillary supplies compared to IMP.
Speakers:
Opportunities to Enhance Patients' Site Experience with IMP
Learning Objectives:
● Give at least two (2) examples of poorly designed or labeled investigational product and how they could have been improved.
● Identify at least three (3) techniques for packaging or labeling investigational supplies that can enhance patient compliance.
● Explain the potential negative impact of poor experiences with IMP.
Speakers:
QP Update: The New Clinical Trials Regulation and IMPs
Learning Objectives:
● Summarize the impact of the new EU Clinical Trials Regulation on IMPs.
● Outline the changes to the Clinical Trial Application process resulting from the new Clinical Trials Regulation.
● Compare and contrast the QP release process versus QA release.
Speakers:
Recalling IMPs: Do You Know Where Your Drug Is?
Learning Objectives:
● List at least two (2) reasons to recall investigational products.
● Justify a mock recall procedure.
● Compare and contrast the recall of investigational product versus commercial product.
Speakers:
Strategic Tools to Shorten Timelines for IMP Availability
Learning Objectives:
● Give examples of at least two (2) strategies to shorten IMP production timelines.
● Explain the importance of building IMP vendor-partner relations and communication to improve speed and quality.
● Give at least one (1) example of how to successfully shorten production timelines using available industry tools.
Speakers:
Taking the Fear out of Regulatory Audits
Learning Objectives:
● Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.
● List three (3) key areas of focus when preparing for a regulatory audit.
● List two (2) benefits of conducting a self-audit.
Speakers:
Update on Expiry Date Management
Learning Objectives:
● Identify information / documentation that has been critical in both educating and influencing regulators to accept removal of expiry dates from investigational product labels.
● Give examples of at least two (2) activities that will prevent use of expired medication if the expiry date is not printed on the label.
● Explain the potential impact of the new EU Clinical Trials Regulation on efforts to remove expiry dates from IMP labeling.
Speakers:
Using Key Performance Indicators (KPI) and Metrics to Improve Your Efficiency
● Give at least two (2) examples of metrics that can be used to monitor performance in the clinical supply chain.
● Compare and contrast the use of KPIs for internal and outsourced activities.
● List at least three (3) ways KPIs/metrics can be communicated to stakeholders.
Speakers:
Clinical Material Challenges for Devices and Drug/Device Combinations
Learning Objectives:
● Compare and contrast the challenges presented by packaging devices or drug/device combinations versus traditional IMP.
● Differentiate the regulatory requirements for devices or drug/device combinations versus traditional IMP.
● Give examples of at least two (2) challenges involved in the import/export of devices or drug/device combinations compared to traditional IMP.
Speakers:
Introduction to Returns and Reconciliation - 101
Learning Objectives:
● Explain the regulatory basis for the returns and reconciliation process.
● Outline the important elements of IMP reconciliation at clinical sites.
● Diagram the flow of product from clinical supplies distribution center through receipt at a returns collection center, and indicate appropriate points of reconciliation.
Speakers:
Issues and Challenges with Biologic IMP and Comparators
Learning Objectives:
● Compare and contrast challenges between large and small molecule IMP programs.
● List at least two (2) handling concerns specific to biologic/ large molecule IMPs.
● Give examples of at least two (2) challenges to conducting global studies with biologic IMP or comparators
Speakers:
Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage
Learning Objectives:
● Explain the importance of tracking time-out-of-environment for cold chain investigational products.
● Describe at least two (2) types of stability studies that support investigational product time-out-of-environment.
● List at least two (2) challenges to tracking time-out-of environment for cold chain products.
Speakers:
Managing the Devastating Physical and Mental Effects of the Stress of Clinical Supplies
Learning Objectives:
● List at least three (3) physically and psychologically detrimental effects of stress.
● Describe four (4) things to do to decrease stress to better cope with the pressures of clinical supplies.
● Give examples of at least three (3) ways to enhance work-life balance.
Speakers:
Packaging Innovations: Enhance Your IMP Design
Learning Objectives:
● Give at least two (2) examples of recent innovations in packaging designs specific for IMP.
● Explain the benefits of innovative packaging designs to the conduct of clinical trials.
● Compare and contrast innovative packaging techniques with traditional bottles and wallets
Speakers:
Technologies to Improve Patient Compliance with IMP
Learning Objectives:
● Explain the impact of poor patient compliance with IMP on clinical studies.
● Give at least three (3) examples of technologies that can improve patient compliance.
● Describe the cost-benefits of compliance technologies to gain operational support for such initiatives.
Speakers:
Using SharePoint to Improve IMP Management and Communication
Learning Objectives:
● Give examples of at least two (2) challenges to implementing cloud-based systems in a GMP environment.
● List at least two (2) benefits to IMP management incurred by using SharePoint.
● Define cloud-based storage, portal, computer system validation.
Speakers:
When Things Go Wrong: Case Studies of Clinical Supply Errors and How to Prevent Them
Learning Objectives:
● Give at least three (3) examples in the clinical supply chain which require attention to avoid disastrous errors.
● Identify at least three (3) strategies to reduce the risks associated with preparing blinded clinical trial medication.
● Identify at least three (3) strategies to reduce the risks associated with shipping cold chain IMP.
Speakers:
Advanced Planning and Forecasting Tools - 501
Learning Objectives:
● Explain the cost benefit of forecasting tools, especially in multi-protocol drug development programs.
● Describe at least two (2) complex IMP management scenarios which would benefit from advanced forecasting techniques.
● List at least two (2) metrics used to measure IMP management.
Speakers:
Biosimilars and Biobetters: More than Generic Biologicals
Learning Objectives:
● Define biosimilars and biobetters.
● Identify at least two (2) key differences in the development of biosimilars/ biobetters compared to the innovator product.
● List at least two (2) challenges to clinical supplies for studies supporting biosimilar/ biobetter development
Speakers:
Enhanced IMP Training Using Mock Kits ("Demo Kits")
Learning Objectives:
● Give at least two (2) scenarios where mock kits can enhance training.
● Describe the preparation and control procedures for mock kits compared to clinical supplies.
● List the site personnel most likely to benefit from the use of demo kits for training.
Speakers:
Management of Ancillary Supplies used in Clinical Trials
Learning Objectives:
● Give at least two (2) examples of the benefits of managing ancillary supplies along with IMP.
● Evaluate at least two (2) different strategies for providing ancillary supplies to clinical study sites
● Describe at least two (2) unique challenges associated with management of ancillary supplies compared to IMP.
Speakers:
Opportunities to Enhance Patients' Site Experience with IMP
Learning Objectives:
● Give at least two (2) examples of poorly designed or labeled investigational product and how they could have been improved.
● Identify at least three (3) techniques for packaging or labeling investigational supplies that can enhance patient compliance.
● Explain the potential negative impact of poor experiences with IMP.
Speakers:
QP Update: The New Clinical Trials Regulation and IMPs
Learning Objectives:
● Summarize the impact of the new EU Clinical Trials Regulation on IMPs.
● Outline the changes to the Clinical Trial Application process resulting from the new Clinical Trials Regulation.
● Compare and contrast the QP release process versus QA release.
Speakers:
Recalling IMPs: Do You Know Where Your Drug Is?
Learning Objectives:
● List at least two (2) reasons to recall investigational products.
● Justify a mock recall procedure.
● Compare and contrast the recall of investigational product versus commercial product.
Speakers:
Update on Expiry Date Management
Learning Objectives:
● Identify information / documentation that has been critical in both educating and influencing regulators to accept removal of expiry dates from investigational product labels.
● Give examples of at least two (2) activities that will prevent use of expired medication if the expiry date is not printed on the label.
● Explain the potential impact of the new EU Clinical Trials Regulation on efforts to remove expiry dates from IMP labeling.
Speakers:
Using Key Performance Indicators (KPI) and Metrics to Improve Your Efficiency
Learning Objectives:
● Give at least two (2) examples of metrics that can be used to monitor performance in the clinical supply chain.
● Compare and contrast the use of KPIs for internal and outsourced activities.
● List at least three (3) ways KPIs/metrics can be communicated to stakeholders.
Speakers:
Using SharePoint to Improve IMP Management and Communication
Learning Objectives:
● Give examples of at least two (2) challenges to implementing cloud-based systems in a GMP environment.
● List at least two (2) benefits to IMP management incurred by using SharePoint.
● Define cloud-based storage, portal, computer system validation.
Speakers:
Day 4 : Wednesday, April 29
Clinical Material Challenges for Devices and Drug/Device Combinations
Learning Objectives
● Compare and contrast the challenges presented by packaging devices or drug/device combinations versus traditional IMP.
● Differentiate the regulatory requirements for devices or drug/device combinations versus traditional IMP.
● Give examples of at least two (2) challenges involved in the import/export of devices or drug/device combinations compared to traditional IMP.
Speakers:
Issues and Challenges with Biologic IMP and Comparators
Learning Objectives:
● Compare and contrast challenges between large and small molecule IMP programs.
● List at least two (2) handling concerns specific to biologic/ large molecule IMPs.
● Give examples of at least two (2) challenges to conducting global studies with biologic IMP or comparators
Speakers:
Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage
Learning Objectives
● Explain the importance of tracking time-out-of-environment for cold chain investigational products.
● Describe at least two (2) types of stability studies that support investigational product time-out-of-environment.
● List at least two (2) challenges to tracking time-out-of environment for cold chain products.
Speakers:
Opportunities to Enhance Patients' Site Experience with IMP
Learning Objectives
● Give at least two (2) examples of poorly designed or labeled investigational product and how they could have been improved.
● Identify at least three (3) techniques for packaging or labeling investigational supplies that can enhance patient compliance.
● Explain the potential negative impact of poor experiences with IMP.
Speakers:
Packaging Innovations: Enhance Your IMP Design
Learning Objectives:
● Give at least two (2) examples of recent innovations in packaging designs specific for IMP.
● Explain the benefits of innovative packaging designs to the conduct of clinical trials.
● Compare and contrast innovative packaging techniques with traditional bottles and wallets
Speakers:
QP Update: The New Clinical Trials Regulation and IMPs
Learning Objectives:
● Summarize the impact of the new EU Clinical Trials Regulation on IMPs.
● Outline the changes to the Clinical Trial Application process resulting from the new Clinical Trials Regulation.
● Compare and contrast the QP release process versus QA release.
Speakers:
Strategic Tools to Shorten Timelines for IMP Availability
Learning Objectives:
● Give examples of at least two (2) strategies to shorten IMP production timelines.
● Explain the importance of building IMP vendor-partner relations and communication to improve speed and quality.
● Give at least one (1) example of how to successfully shorten production timelines using available industry tools.
Speakers:
Taking the Fear out of Regulatory Audits
Learning Objectives
● Compare and contrast the areas of focus one would expect to see in a cGMP audit versus a cGCP audit.
● List three (3) key areas of focus when preparing for a regulatory audit.
● List two (2) benefits of conducting a self-audit.
Speakers:
Technologies to Improve Patient Compliance with IMP
Learning Objectives:
● Explain the impact of poor patient compliance with IMP on clinical studies.
● Give at least three (3) examples of technologies that can improve patient compliance.
● Describe the cost-benefits of compliance technologies to gain operational support for such initiatives.
Speakers:
Advanced Planning and Forecasting Tools - 501
Learning Objectives
● Explain the cost benefit of forecasting tools, especially in multi-protocol drug development programs.
● Describe at least two (2) complex IMP management scenarios which would benefit from advanced forecasting techniques.
● List at least two (2) metrics used to measure IMP management.
Speakers:
Biosimilars and Biobetters: More than Generic Biologicals
Learning Objectives
● Define biosimilars and biobetters.
● Identify at least two (2) key differences in the development of biosimilars/ biobetters compared to the innovator product.
● List at least two (2) challenges to clinical supplies for studies supporting biosimilar/ biobetter development
Speakers:
Introduction to Returns and Reconciliation - 101
Learning Objectives
● Explain the regulatory basis for the returns and reconciliation process.
● Outline the important elements of IMP reconciliation at clinical sites.
● Diagram the flow of product from clinical supplies distribution center through receipt at a returns collection center, and indicate appropriate points of reconciliation.
Speakers:
Management of Ancillary Supplies used in Clinical Trials
Learning Objectives
● Give at least two (2) examples of the benefits of managing ancillary supplies along with IMP.
● Evaluate at least two (2) different strategies for providing ancillary supplies to clinical study sites
● Describe at least two (2) unique challenges associated with management of ancillary supplies compared to IMP.
Speakers:
Managing the Devastating Physical and Mental Effects of the Stress of Clinical Supplies
Learning Objectives
● List at least three (3) physically and psychologically detrimental effects of stress.
● Describe four (4) things to do to decrease stress to better cope with the pressures of clinical supplies.
● Give examples of at least three (3) ways to enhance work-life balance.
Speakers:
Recalling IMPs: Do You Know Where Your Drug Is?
Learning Objectives
● List at least two (2) reasons to recall investigational products.
● Justify a mock recall procedure.
● Compare and contrast the recall of investigational product versus commercial product.
Speakers:
Update on Expiry Date Management
Learning Objectives
● Identify information / documentation that has been critical in both educating and influencing regulators to accept removal of expiry dates from investigational product labels.
● Give examples of at least two (2) activities that will prevent use of expired medication if the expiry date is not printed on the label.
● Explain the potential impact of the new EU Clinical Trials Regulation on efforts to remove expiry dates from IMP labeling.
Speakers:
Using Key Performance Indicators (KPI) and Metrics to Improve Your Efficiency
Learning Objectives
● Give at least two (2) examples of metrics that can be used to monitor performance in the clinical supply chain.
● Compare and contrast the use of KPIs for internal and outsourced activities.
● List at least three (3) ways KPIs/metrics can be communicated to stakeholders.
Speakers:
Using SharePoint to Improve IMP Management and Communication
Learning Objectives
● Give examples of at least two (2) challenges to implementing cloud-based systems in a GMP environment.
● List at least two (2) benefits to IMP management incurred by using SharePoint.
● Define cloud-based storage, portal, computer system validation.
Speakers:
When Things Go Wrong: Case Studies of Clinical Supply Errors and How to Prevent Them
Learning Objectives
● Give at least three (3) examples in the clinical supply chain which require attention to avoid disastrous errors.
● Identify at least three (3) strategies to reduce the risks associated with preparing blinded clinical trial medication.
● Identify at least three (3) strategies to reduce the risks associated with shipping cold chain IMP.
Speakers:
