Navigation Links
FDAnews Announces — New Book — Clinical Trials Adverse Event Reporting Guide, 2017 Edition
Date:10/9/2017

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.

Read the full story at http://www.prweb.com/releases/FDAnews/ctadverseeventreporting/prweb14756180.htm.


'/>"/>
Source: PRWeb
Copyright©2017 Vocus, Inc.
All rights reserved


Related medicine news :

1. FDAnews Announces — New Management Report — ClinicalTrials.gov: Mastering New Reporting Rules
2. FDAnews Database — Limited Time Offer Save $500 on 483sOnline.com
3. FDAnews Announces — New Management Report — Efficient Premarket Applications: Three FDA Submission Paths That Require Less Time, Money and Effort
4. FDAnews Announces — New Management Report — Principles of Equipment Qualification: A Guide for Drug and Device Manufacturers
5. FDAnews Announces: Data Integrity: The Key to FDA and GMP Compliance, Dec. 5-6, 2017, Arlington, VA
6. FDAnews Announces — FDAnews Expert Insight Series: Device Regulation Under Gottlieb & Trump Webinar, Oct. 12, 2017
7. FDAnews Announces: Flawless FDA Inspection Handling and Response Preconference Workshop for the 12th Annual FDA Inspections Summit, November 1-3, 2017, Bethesda, MD
8. FDAnews Announces — Process Capability Indices for Medical Device Manufacturers Webinar, Sept. 26, 2017
9. FDAnews Announces — New Management Report — Promotional Communication: Keeping Up with FDA’s Off-Label Use Policy
10. FDAnews Announces: Early Bird Pricing Ends Sept. 22 for Medical Device Supplier Quality Management, Oct. 17-18, 2017, Cambridge, MA
11. FDAnews Announces: Early Bird Pricing Ends Sept. 22 for Conducting Advanced Root Cause Analysis CAPA Investigations, Oct. 23-24, 2017, Arlington, VA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2019)... ... June 18, 2019 , ... ... cancers and other serious diseases, announced it has received notice that the US ... Humanitarian Device Exemption (HDE) for the Hælo Pediatric system. The FDA granted ...
(Date:6/18/2019)... (PRWEB) , ... June 18, 2019 , ... ... and clinical outcomes, today announced Steve Einig has joined the organization in the ... strategy and corporate initiatives around market engagement, marketing, strategic events and brand management. ...
(Date:6/16/2019)... , ... June 16, 2019 , ... ... MMJ International Holdings executives focusing on scientific research for the advancement of medical marijuana-based ... on CNBC. Check your local listings for more information. , With two investigational new ...
(Date:6/13/2019)... ... 13, 2019 , ... Endometriosis is a painful, inflammatory disease that occurs when tissue grows outside ... periods , Heavy bleeding , Irregular menstruation , Severe ... Excellence uses the latest and newest treatment protocols in dealing with the symptoms of endometriosis. ...
(Date:6/13/2019)... ... June 13, 2019 , ... In Partnership with the Smiles ... low-income, underinsured individuals at its Mesquite, TX office on July 13th. , Dental services ... and extractions . For more information, please visit the Monarch Dental ...
Breaking Medicine News(10 mins):
(Date:6/18/2019)... ... June 18, 2019 , ... Officials with American ... services, are pleased to announce the acquisition of Leading Edge Medical Associates (LEMA), ... 34 physicians and 9 advanced practice clinicians care for 115,000 emergency department patients ...
(Date:6/16/2019)... , ... June 15, 2019 , ... ... just published results of a clinical study on its new prebiotic, LycoBiotic™, which ... different nutraceutical capsule and chocolate formulations, which were based on a proprietary composition ...
(Date:6/14/2019)... ... June 14, 2019 , ... ... a forecasting and analytics platform that helps Life Sciences Manufacturers accurately project ... for Life Sciences business leaders: accurate, automated forecasting of rebates and discounts ...
Breaking Medicine Technology: