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Preparation, Packaging and Labeling of Clinical Trial Materials

  December 03, 2012  
CfPA - The Center for Professional Advancement, Amsterdam, The Netherlands
8-9 April 2013

Who Should Attend
This survey course will emphasize the procedures and techniques needed to prepare compliant clinical trial supplies. The course is intended for personnel who are new to the clinical supply process as well as for those who have experience in Clinical Trial Materials (CTM) preparation but want to update or refresh their knowledge. This includes, but is not limited to, those involved in:

  • Packaging 
  • Labeling
  • Quality Assurance/Control 
  • Clinical Manufacturing
  • Regulatory Affairs 
  • Research & Development
  • Contract Packaging

The aim of this survey course is to provide an overview and introduction to the many details that must be considered in the design, preparation, packaging, labeling and distribution of clinical trial materials in support of adequate and well controlled clinical studies. Emphasis will be given to practical examples of procedures, components, and regulatory requirements needed to provide acceptable investigational materials. Comparison of the requirements of the United States and Europe and consideration of the harmonization of international clinical studies will be given.

The interrelationships of the industrial pharmacist, clinical research associate, medical monitor, regulatory officer, clinical pharmacist, clinical supplies and quality assurance/control personnel will be discussed. In addition, cGMP will be reviewed to ensure compliance during the preparation, use and return of the trial materials.

The course provides participants the opportunity to share experiences with faculty and colleagues about effective methods to design, produce, package, and label clinical trial materials. The concepts presented during the course are integrated by means of case studies that consider real-world clinical trial supply problems and solutions.

Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Thomas Miller; Clinical Supplies Program Manager, ImClone Systems Corporation

Thomas Miller is a Clinical Supplies Program Manager at ImClone International GmbH, a wholly-owned subsidiary of Eli Lilly and Co. He currently manages the packaging, labeling, and global distribution of the lead candidate in ImClone’s pipeline. Prior to joining ImClone, he was a Senior Manager leading the Mount Laurel Project Management group at Aptuit, Inc., which provides contract packaging, labeling, and distribution services for the biotech and pharmaceutical industries. Mr. Miller has been the clinical supplies project lead in studies covering all phases of clinical studies, including many indications, and encompassing most regions of the globe. Prior to joining Aptuit, Mr. Miller spent approximately 10 years in the biotech industry as a molecular biologist and laboratory manager.

Mr. Miller has been presenting in the Center for Professional Advancement’s program on Preparation, Packaging, and Labeling of Clinical Supplies since 2005. He is an active member of ISPE’s Investigational Product Community of Practice. Mr. Miller received his Bachelor’s degree in Biology at Rutgers University.
Deadline for Abstracts: n/a
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
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