S3C3：Pharmaceutical Labeling

原文始发于微信公众号（化学音乐文化）：S3C3：Pharmaceutical Labeling

JanFourman,PhD, EdD,MBA, MSRA

S3C3：Pharmaceutical Labeling

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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Pharmaceutical Labeling

Part 1 – Summary of Labeling Requirements

Introduction

General Labeling Requirements (CFR 201 Subparts A and B)

Electronic Labeling

Package Insert:

Physician’s Labeling Rule (PLR)

Medication Guides

Label Changes

Part 2 – Advertising and PromotionNo Preapproval Promotion

Material Submission and Preclearance

Substantial Evidence Standard

Fair Balance

Non-print Promotion

Part 3 – Serialization

Drug Supply Chain Security Act (DSCSA):

Overview

Product Tracing

Authorized Trading Partners

Suspect Products

Product Identification

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