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Preliminary Workshops

Workshop Title

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.

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