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

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

Date	Location	Country	Instructor(s)
4-5 March 2013	Baltimore, Maryland	USA	David Glynn
22-23 May 2013	Brussels	Belgium	Antonia Daniel
9-10 September 2013	Burlingame, California	USA	David Glynn
11-12 December 2013	Tampa, Florida	USA	David Glynn

Description

CTM Managers continue to play a critical role in a company’s ability to efficiently bring life-saving products to market. Unfortunately in todays 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’ll 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 and Randomization
Packaging and Labeling
Logistics and Clinical Supply Chain Management – including managing returns and accountability
Interactive Response Technology (IRT) – design and practical application
The Role of Quality
Preparing for GMP and GCP Inspections
CTM Definitions and References

Guide Cover Image

Participants will receive a complimentary copy of the Comprehensive Guide to Clinical Materials: A Handbook for Training Clinical Materials Professionals.

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

CPIP™ Technical Knowledge and Competency Elements

This course contains knowledge related to the CPIP™ technical knowledge competency element Product Development: Formulation, clinical phases and manufacture. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.

Continuing Education Units

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.

Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

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