Clinical Trial Materials: Applying Production, Quality Assurance and Packaging Processes (T13)

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Level: Fundamental/Intermediate - Application
ISPE CEUs: 1.3
Type: Classroom Training Course

Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

CTM Managers continue to play a critical role in a company’s ability to efficiently bring life-saving products to market. Unfortunately in today’s high-pressure and time sensitive research environment, CTM Managers frequently learn while focusing on the specific requirements of an assigned trial, with less priority being given to the critical need for solid training in all aspects of CTM management.

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 CTM and how to implement the plan and troubleshoot. The course will also cover 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 will be covered to ensure familiarity with all the necessary concepts.

Participants will discuss the different roles of the Clinical Team and how they interact with the CTM group. We will also cover current Good Manufacturing Practices (cGMPs) and how they are implemented in the packaging process. The course will also provide a dictionary of terms used in the CTM industry and how they apply to our daily business. After taking this course, you will be better prepared to manage every aspect of CTM for your clinical trials!

Course Modules

  • CTM Management - then, now and looking forward
  • Stages of Drug Development
  • Approaches to CTM Project Management
  • Protocol Interpretation and package design
  • Project Planning
  • Clinical Manufacturing & Comparator Procurement
  • Labels
  • Randomization
  • Packaging and Labeling
  • Logistics and Clinical Supply Chain Management – including managing returns and accountability
  • Interactive Response Technology (IRT) – design and practical application
  • Approaches to Project Management
  • Preparing for GMP and GCP Inspections
  • CTM Definitions and References

Booklet Labels Cover Image

Participants will receive a complimentary copy of the ISPE Good Practice Guide: Booklet Labels electronic download

Take Back to Your Job

  • Translating a clinical study protocol to define CTM supply requirements
  • Understand and apply documentation, cGMPs, and regulatory considerations specifically affecting CTM
  • Know how to prepare a project plan for all major steps in CTM production – manufacturing, packaging, labeling and distribution
  • Identify the roles of the project team and how CTM interacts with each one
  • Ability to apply real-life case studies to your own projects

Attendance Suggested For

  • Pharmaceutical professionals new to the CTM area who are involved in the manufacture, review, packaging and labeling of clinical trial materials
  • Note to Clinical Supply Chain Managers and Supervisors: This is an excellent way to document general training for employees in the areas of cGMPs and CTM operations

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.