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Handling Investigational Drug Products (Introduction) Instructor: Sarah Wilson, MS, CCRP My philosophy: I accept the things I cannot change;  I choose to change whatever I can; And I pray for  wisdom to know the difference .  Reinhold Niebuhr   http://qualitytrialsip.onlineclasses.com
Handling Investigational Drug Products ,[object Object],Biologics  - A preparation, such as a drug, a vaccine, or an antitoxin, that is synthesized from living organisms or their products and used as a diagnostic, preventive, or therapeutic agent. Combination Products  - A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object]
Handling Investigational Drug Products ,[object Object],[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products Investigators Responsibilities
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Handling Investigational Drug Products ,[object Object],[object Object],[object Object],[object Object]
Handling Investigator Drug Products ,[object Object],[object Object],[object Object],[object Object]

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Handling Investigational Product at Clinical Site

  • 1. Handling Investigational Drug Products (Introduction) Instructor: Sarah Wilson, MS, CCRP My philosophy: I accept the things I cannot change; I choose to change whatever I can; And I pray for wisdom to know the difference . Reinhold Niebuhr http://qualitytrialsip.onlineclasses.com
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  • 9. Handling Investigational Drug Products Investigators Responsibilities
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