CfPA-The Center for Professional Advancement, Amsterdam, The Netherlands
16-17 March 2015
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
Description
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.
|
|
|
Invited Speakers:
|
|
Thomas Miller; Manager and Site Head; Clinical Trial Material Manufacturing and Services; Eli Lilly and Company
Thomas Miller is the Manager and Site Head at the New Jersey site of Clinical Trial Material Manufacturing and Services for Eli Lilly and Company. In this role, he is leading integration efforts with Lilly’s clinical supplies group and developing best practices and more efficient operating procedures within ImClone. He was previously the Associate Director of Clinical Supply Logistics and Clinical Supplies Project Manager at ImClone Systems Corporation in the US and Germany, where he managed the packaging, labeling, and distribution of the lead candidate in ImClone’s pipeline. Prior to joining ImClone, he led the Mount Laurel Project Management group at Aptuit, Inc. (now part of Catalent), which provides contract packaging, labeling, and distribution services for the biotech and pharmaceutical industries. pharmaceutical industries. Mr. Miller has been the clinical supplies lead in all phases of clinical studies, including many indications, and encompassing most regions of the globe. He spent the first 10 years of his career in the biotech industry as a molecular biologist and laboratory manager.
Mr. Miller received his Bachelor’s degree in Biology at Rutgers University, New Brunswick, NJ.
|
|