S1C4:Drug Product Submissions: eCTD Module 3

原文始发于微信公众号(化学音乐文化):S1C4:Drug Product Submissions: eCTD Module 3

S1C4:Drug Product Submissions: eCTD Module 3

JanFourman,PhD, EdD,MBA, MSRA

S1C4:Drug Product Submissions: eCTD Module 3

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

S1C4:Drug Product Submissions: eCTD Module 3
S1C4:Drug Product Submissions: eCTD Module 3

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Drug Product Submissions: eCTD Module 3

S1C4:Drug Product Submissions: eCTD Module 3

Quality Data of Module 3:

Chemistry, Manufacturing and Controls (CMC)

Drug Substance and Product

Formulation

Packaging

Distribution

Packaging Agenda

Defines package “labeling” and its purpose

Briefly reviews the label development processFrom Target Product Profile (TPP) to Printed Packaging Development (PPD)

PPD logistics

PPD challenges

Submission amendments

Misbranding

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