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Clinical Trial Materials
Clinical Trial Materials
Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes
In this course, you will receive a thorough overview of the clinical supply chain from beginning to end, including: designing appropriate packaging and labeling to match the study design, creating a plan of action to prepare the Clinical Trial Material (CTM) and how to implement the plan and troubleshoot. The course also covers the logistics of distribution of the CTM to the clinical sites globally. Important tools, such as outsourcing vendors for packaging and labeling and Interactive Response Technology along with Randomizations will be covered to ensure familiarity with all the necessary concepts. Additional content will focus on the roles of the Clinical Project Team and how they interact with the CTM group and the regulatory framework needed to stay abreast of regulatory changes.

Course Modules/Learning Objectives

Module 1: Introduction to CTM
  • Explore Change and reasons for change.
  • Discuss Industry Landscape to identify "then" and "now".
  • Identify future industry forecast and consider how roles may change.
  • Understand the various Phases in the Drug Development process.
Module 2: Protocol Develop and Interpretation
  • Identify the protocol contents
  • Understand what part of the protocol a CTM specialist should review.
Module 3: Partnering with Clinical Manufacturing
  • Review various considerations for the CTM Specialist.
  • Review current regulations.
  • Discuss less predictable areas which manufacturing can have a significant influence.
Module 4: Working with Comparators
  • Examine milestones, decision points and resources involved in working with comparators.
  • Learn questions to ask.
  • Explore various assessments when reaching a decision regarding comparators.
  • Review real-life examples of challenges faced when working with comparators.
Module 5: Label Design, Approval and Production
  • Review label types, text, design and production.
  • Understand regulatory label requirements and the process for approval.
Module 6: Randomizations and How They are Used
  • Identify types of randomization lists.
  • Discuss treatment lists and block size.
  • Review randomization generation.
  • Identify kit combining treatment and kit lists.
Module 7: Packaging and Labeling
  • Review packaging and labeling process for CTM.
  • Discuss the ways in which GMP impacts the packaging and labeling process.
  • Identify different types of packaging.
  • Review the role of QA/QP.
  • Explore responsibilities of the sponsor and the packaging and labeling vendor.
Module 8: Logistics
  • Explain chain of custody.
  • Discuss elements of designing a clinical supply chain; planning, network, cold chain, import/export, returns and destruction.
  • Prepare the distribution strategy.
Module 9: Interactive Response Technology Systems
  • Discuss roles, user requirement specification settings and medication management.
  • Review the use at depots and at sites.
  • Understand standard IRT reports and user acceptance tests.
Module 10: Approaches to Project Management
  • Explore a look into high level stages of project management and discuss tools and practices that can help with each stage.
  • Review planning and putting into practice.
  • Discuss various project management tools and their uses.
Module 11: Quality and Regulatory, Inspections
  • Explore the Quality and Regulatory stakeholders that CTM Specialists work regularly with.
  • Discuss the role of the qualified person.
  • Review regulatory and inspection processes.
Attendance Suggested For:
  • Pharmaceutical professionals that are new to the Clinical Supply area who are involved in the manufacture, review, labeling of clinical trial materials. Pharmaceutical professionals who need to know how to use Interactive Voice Response. Pharmaceutical professionals who want to understand
Discounted member price: 600.00
You could save 14.3%
This self-paced, pre-recorded course includes a downable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation.

Approximate Course Duration: 2 Days (this is a self-paced course)

*NOTE*You will have 14 calendar days to access and complete this course from time of purchase

ISPE CEUs: .60 ISPE CEUs will be awarded upon successful completion of grading requirements

Community of Practice (COP): This training course is of particular interest to existing and future members of the ISPE Investigational Products (IP) Community of Practice (COP).

Member Price: $ 600.00 / € 492.00
Non Member Price: $ 700.00 / € 574.00