S3C7：Cell and Gene Therapies

原文始发于微信公众号（化学音乐文化）：S3C7：Cell and Gene Therapies

JanFourman,PhD, EdD,MBA, MSRA

S3C7：Cell and Gene Therapies

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

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Quality Systems

Background on Regenerative Medicine

Human Cell and Tissue Products

Good Tissue Practices (GTPs)

Autologous Therapies and Same Surgical Procedure Exemptions

CMC Considerations

Quality System (Biologic Compliance)

Cell Banking

Characterization and Release Testing

Preclinical Recommendations

Clinical Considerations

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