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Quality and Regulatory Affairs

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MaRS Discovery District
MaRS Discovery District

James Ault, VP Quality and Regulatory Affairs, Ricerca Biosciences, LLC discusses Regulatory IND Process for drug discovery as part of a pre-clinical development workshop. Available for download from the <a href="http://www.marsdd.com/servlets/sfs?t=/contentManager/onStory&e=UTF-8&i=1125077882365&l=0&s=KViiqiXDtBtVMFUcybn&active=no&ParentID=1138394059511&sort=Price&StoryID=1168016720154" target="_blank">MaRS website at www.marsdd.com</a>.

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Regulatory IND Process James Ault, RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs
Regulatory IND Process ,[object Object],[object Object],[object Object]
Regulatory IND Process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Fundamental Principle ,[object Object]
What is “Substantial Evidence”? ,[object Object],[object Object],[object Object],[object Object]
Here’s What the FDA Wants from You ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
When Do You File an IND? ,[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Strategy ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Application ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 7: Chemistry, Manufacturing and Controls ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is cGMP? Good Manufacturing Practices Shipping/Receiving Raw Mats/Supplies Quarantine-Test-Release Processing - batch records Validated facilities/equip. Good documentation Test product Documentation reviewed by QA - Release/Reject Label and ship to client Archive data and records Wait for FDA to appear
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object]
IND Item 8: Non-clinical Pharmacology and Toxicology ,[object Object],[object Object],[object Object],[object Object],[object Object]
What is GLP? Good Laboratory Practices Adequate Facility Qualified Personnel - Technical and Quality Unit Protocol and SD Unique Suitable Test Systems Characterized Test Materials/Controls Effective SOPs Accurate/Timely Data Accurate/Complete Report Secure Archives
FDA’s Role Reviewing IND Submissions ,[object Object],[object Object],[object Object],[object Object]
Grounds for IND Clinical Hold ,[object Object],[object Object],[object Object],[object Object],[object Object]
Causes for Rejection ,[object Object],[object Object],[object Object],[object Object],[object Object]
FDA’s Regulatory Aspect - IND ,[object Object],[object Object],[object Object],[object Object]
Agency Interaction/Meetings ,[object Object],[object Object],[object Object],[object Object]
Agency Interaction/Meetings ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory IND Process ,[object Object],[object Object],[object Object]

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Quality and Regulatory Affairs

  • 1. Regulatory IND Process James Ault, RAC, RQAP-GLP VP Quality and Regulatory Affairs Ricerca Biosciences, LLC May 23, 2007 Quality and Regulatory Affairs
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  • 18. What is cGMP? Good Manufacturing Practices Shipping/Receiving Raw Mats/Supplies Quarantine-Test-Release Processing - batch records Validated facilities/equip. Good documentation Test product Documentation reviewed by QA - Release/Reject Label and ship to client Archive data and records Wait for FDA to appear
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  • 22. What is GLP? Good Laboratory Practices Adequate Facility Qualified Personnel - Technical and Quality Unit Protocol and SD Unique Suitable Test Systems Characterized Test Materials/Controls Effective SOPs Accurate/Timely Data Accurate/Complete Report Secure Archives
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