S3C4:Pharmacovigilance

原文始发于微信公众号(化学音乐文化):S3C4:Pharmacovigilance

S3C4:Pharmacovigilance

JanFourman,PhD, EdD,MBA, MSRA

S3C4:Pharmacovigilance

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

S3C4:Pharmacovigilance
S3C4:Pharmacovigilance

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Pharmacovigilance

Part 1 – Drug Pharmacovigilance

Define and understand the goal of Pharmacovigilance

Recognize the role of Pharmacovigilance in the drug development process

Realize the importance of adverse event collection

Become familiar with spontaneous and clinical trial adverse event reports

Understand Regulatory reporting requirements and post-marketing surveillance

Part 2 – Core Safety Information

What is core safety information?

What are core safety reporting languages?

MedDRA

ICD-10

What are FDA’s databases for core safety reporting?

Part 3 – Counterfeit Reporting

Impact

Case Studies:

Avastin

Fentanyl

How to report AEs from Counterfeiting

Office of Drug Security, Integrity, and Recalls (ODSIR)

Healthcare Professional’s Role

Part 4 – Safety Collection in Clinical Trials

Introduction

Data Collection:

Who

What

How

When

Follow-up Checklist

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