FALLS CHURCH, Va. (PRWEB)
July 07, 2021

Guide to Safety Reporting for Drugmakers:

FDA Adverse Event Requirements

Compiled FDAnews Report

https://www.fdanews.com/products/61509

How and when should an adverse event report be filed?

The Guide to Safety Reporting for Drugmakers: FDA Adverse Event Requirements contains details on what safety issues to report, when to report them and how to make those reports. It’s a comprehensive guide to the FDA’s requirements regarding adverse events, serious adverse events, adverse drug reactions and postmarket benefit-risk evaluation reports. Through it, readers will gain insights on understanding safety priorities, long-term follow-ups and benefit-risk evaluation reports.

This book will cover:

a.    Definitions of adverse drug reaction, serious adverse event and life-threatening events

b.    How and when to file adverse event reports

c.    Filing periodic benefit-risk evaluation reports

• Key resources for drugmakers

a.    Postmarketing safety reporting for human drug and biological products, including vaccines

b.    Postapproval safety data management

c.    Good pharmacovigilance practices and pharmacoepidemiologic assessment

d.    Premarketing risk assessment

e.    Answers on FDA’s Adverse Event Reporting System (FAERS)

f.    Guidance from the International Council on Harmonization (ICH)

• Safety priorities and goals

a.    Center for Drug Evaluation and Research safety priorities

b.    Safety reporting requirements for combination products

Safety reporting is required as part of your postmarket reporting activities. This compilation book is the guide one needs to ensure consumers are being kept safe and following regulatory requirements.

Compiled Report Details:

Guide to Safety Reporting for Drugmakers:

FDA Adverse Event Requirements

Compiled FDAnews Report

https://www.fdanews.com/products/61509

Price:

$397

Easy Ways to Register:

Online: https://www.fdanews.com/products/61509

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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