FDAnews Announces — New Book — Clinical Trials Adverse Event Reporting Guide, 2017 Edition

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The FDA requires clinical trial sponsors to report any patient’s serious adverse drug reaction if the sponsor determines that the “information qualifies for reporting” under section 312.32 of its Investigational New Drug Application rules. A lot rides on that simple four-word phrase.

FDAnews

FDAnews

Clinical Trials Adverse Event Reporting Guide, 2017 Edition
**An FDAnews Book**
http://www.fdanews.com/products/54909-clinical-trials-adverse-event-reporting        

The FDA requires clinical trial sponsors to report any patient’s serious adverse drug reaction if the sponsor determines that the “information qualifies for reporting” under section 312.32 of its Investigational New Drug Application rules. A lot rides on that simple four-word phrase including:

  • What are the qualifications?
  • How does the sponsor report?
  • What is the deadline for reporting?
  • What should the report include?

And most important: What are the consequences of failing to report?

Find the answers to those questions and many more in the 2017 edition of Clinical Trials Adverse Event Reporting Guide. The completely revised and updated guide includes more than 300 pages of FDA guidance on adverse event reporting.

Don’t let a clinical trial fail just because of not knowing the reporting rules. They’re all in the guide. Here are the new titles included in the new edition:

  • Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations
  • Safety Assessment for IND Safety Reporting

Readers ill also find the text of 21 CFR Part 312, the regulations governing the IND program.
Who Will Benefit:

  • Site managers
  • Trial sponsors
  • Principle investigators
  • CROs

FDAnews Book Details:
Clinical Trials Adverse Event Reporting Guide, 2017 Edition
Price: $397
http://www.fdanews.com/products/54909-clinical-trials-adverse-event-reporting    

Easy Ways to Order:
Online:     http://www.fdanews.com/products/54909-clinical-trials-adverse-event-reporting        
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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Michelle Butler
FDANEWS
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