Packaging Innovations: Enhance Your IMP Design
- 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.
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.
Introduction to Returns and Reconciliation – 101
- 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.
Technologies to Improve Patient Compliance with IMP
- 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.
Issues and Challenges with Biologic IMP and Comparators
- 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
Strategic Tools to Shorten Timelines for IMP Availability
- 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.
Update on Expiry Date Management
- 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.
QP Update: The New Clinical Trials Regulation and IMPs
- 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.
Using SharePoint to Improve IMP Management and Communication
- 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.
Biosimilars and Biobetters: More than Generic Biologicals
- 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.
Advanced Planning and Forecasting Tools – 501
- 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.
Management of Ancillary Supplies used in Clinical Trials
- 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.
Opportunities to Enhance Patients’ Site Experience with IMP
- 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.
Enhanced IMP Training Using Mock Kits (“Demo Kits”)
- 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.
Clinical Material Challenges for Devices and Drug/Device Combinations
- 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.
‘When Things Go Wrong: Case Studies of Clinical Supply Errors and How to Prevent Them
- 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.
Taking the Fear out of Regulatory Audits
- 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.
Recalling IMPs: Do You Know Where Your Drug Is?
- 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.
Managing the Devastating Physical and Mental Effects of the Stress of Clinical Supplies
- 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.
Maintaining Cold Chain IMP Integrity During Packaging, Labeling, and Storage
- 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.
Pre-Conference Workshop - Clinical Supplies 101
- Describe at least 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 requirements when shipping temperature-controlled IMPs.