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

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

S3C7:Cell and Gene Therapies
S3C7:Cell and Gene Therapies

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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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