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

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

S3C2:Postapproval Prescription Drug Submissions and Compliance
S3C2:Postapproval Prescription Drug Submissions and Compliance

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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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