S1C3:Prescription Drug Product Submissions: NDA

原文始发于微信公众号(化学音乐文化):S1C3:Prescription Drug Product Submissions: NDA

S1C3:Prescription Drug Product Submissions: NDA

JanFourman,PhD, EdD,MBA, MSRA

S1C3:Prescription Drug Product Submissions: NDA

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

S1C3:Prescription Drug Product Submissions: NDA
S1C3:Prescription Drug Product Submissions: NDA

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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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