S1C2 ：Prescription Drug Product Submissions

原文始发于微信公众号（化学音乐文化）：S1C2 ：Prescription Drug Product Submissions

JanFourman,PhD, EdD,MBA, MSRA

S1C2 ：Prescription Drug Product Submissions

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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Prescription Drug Product Submissions

What is an Investigational New Drug (IND) application?

How to Organize the IND:

Electronic Common Technical Document (eCTD) – Focus on Module 2

Target Product Profile (TPP)

Submission Strategies:

New Chemical Entities (NCEs)

Fast Track Designation

Breakthrough Therapy Designation

Accelerated Approval

Priority Review Voucher

Orphan Drug Designation

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