S3C6:Blood and Blood Products

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S3C6:Blood and Blood Products

JanFourman,PhD, EdD,MBA, MSRA

S3C6:Blood and Blood Products

Eli Lilly – Pharma registration for diabetes/endocrine, women/men’s health, neural science, oncology, bone/muscle/joint therapeutic areas – 5 years
Eli Lilly – Pharmacovigilance – 7 years
Eli Lilly – Regulatory Intelligence – 3 Years
Purdue University and Roche Diagnostics – Teaching global pharma development, Africa and US
Consultant for Indiana Technical Assistance Program
Invited conference speaker
Published author

S3C6:Blood and Blood Products
S3C6:Blood and Blood Products

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Quality Systems

Understand FDA strategies to protect blood supplies

“Five-layer Approach”

Licensing requirements

Advisory committees

Labeling requirements

Circular of Information

Establishments with registration, inspection and “lookback” procedures

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