原文始发于微信公众号（化学音乐文化）：S1C3：Prescription Drug Product Submissions: NDA
JanFourman,PhD, EdD,MBA, MSRA
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
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Prescription Drug Product Submissions: NDA
New Drug Applications:
505(b)(1)
505(b)(2)
505(j) Generics
eCTD Modules 4 and 5
Risk Evaluation and Mitigation Strategy (REMS)
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