S3C2：Postapproval Prescription Drug Submissions and Compliance

原文始发于微信公众号（化学音乐文化）：S3C2：Postapproval Prescription Drug Submissions and Compliance

JanFourman,PhD, EdD,MBA, MSRA

S3C2：Postapproval Prescription Drug Submissions and Compliance

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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Postapproval Prescription Drug Submissions and Compliance

Introduction

Part 1 – Postmarketing Requirements (PMRs)

Part 2 – Postmarketing Commitments (PMCs)

Part 3 – Changes to an Approved Application

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