Navigation Links
Navigating the Gray Areas of Post-Marketing Surveillance
Date:1/28/2011

CHAPEL HILL, N.C., Jan. 28, 2011 /PRNewswire/ -- Drug safety remains front and center for the U.S. Food and Drug Administration as the agency strives to improve the public's perception of the organization. Likewise, the pharmaceutical industry is focused on improving its reputation among consumers and recognizes that its diligence in the reporting of adverse events plays an important role in that effort.

One issue that is impacting both these efforts is the approach to post-marketing surveillance for adverse events for gray areas like the Internet where reporting practices vary across the pharma industry. A Best Practices, LLC post-marketing surveillance study found that 50 percent of the participating companies don't collect AE reports from Internet sources such as blogs or interactive Web events.

Best Practices, LLC has published this report to help drug safety leaders navigate the gray areas of the regulations regarding the reporting of adverse events. Best Practices for Post-Marketing Surveillance of Adverse Events within the United States delivers not only metrics around drug safety reporting processes and sources, but also staffing, follow-up activities and compliance training. Drug safety leaders from 15 organizations shared their practices and insights into the evolving state of post-marketing surveillance of adverse events.

Key topics of this report include:

  • Staff Number (FTEs) and Makeup in Drug Safety Groups
  • Employee Groups Involved in AE Report Assessment
  • Process for Evaluating Adverse Event Reports
  • Most Common Reporting Sources of Adverse Event Reports
  • Main Methods for Follow-Up Activities
  • Adverse Event Report Training
  • Reporting Approach from Various Sources

Review a complimentary summary of the study at http://www3.best-in-class.com/rr1040.htm. Executives, directors and managers at pharmaceutical and biotech organizations who work in drug safety or pharmacovigilance functions can use this research to compare their group's staffing, makeup, AE evaluation process, follow-up activities and training with those of leading organizations.

ABOUT BEST PRACTICES, LLC

Best Practices, LLC, conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC has been a leader in pharmaceutical research and consulting for 17 years; our clients include 48 out of the top 50 pharmaceutical companies. For more information visit: http://www3.best-in-class.com.


'/>"/>
SOURCE Best Practices, LLC
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. New Body of Research Suggests Statin Use Benefits Multiple Areas of Urologic Health
2. Medical Research Council Technologys Centre for Therapeutics Discovery Opens its First Call For Targets in an Effort to Develop Drugs in Areas of Serious Unmet Need
3. Hill-Rom Introduces Smart Bed Technology into CareAssist(R) ES Bed
4. Best Practices, LLC Report on Post-Marketing Surveillance Programs Sheds Light on Gray Areas of Adverse Event Reporting
5. Medco Donates $125,000 to Red Cross for Flood Relief in Tennessee and Other Affected Areas
6. Pfizer Suspends Chronic Pain Studies in Tanezumab Clinical Trial Program; Some Studies Continue in Areas of Unmet Medical Need
7. George Soros to Boost Civil Society Response in Flood Affected Areas of Pakistan
8. Opportunities in Emerging Pharma Markets: Strategies for Optimizing Growth in Key Regions and Therapeutic Areas
9. The Leukemia & Lymphoma Society Targets Research in Four Critical Areas of Unmet Medical Need
10. Cynosure Announces Presentation of Favorable Results from Post-Marketing Studies of Smartlipo MPX
11. AstraZeneca Comments on FDA Joint Advisory Committee Meeting on Post-Marketing Safety Studies for the Use of LABAs in Asthma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... , June 27, 2016  VMS Rehab Systems, ... Board will take whatever measures required to build a ... stock which is currently listed on the OTC Markets-pink ... Company Chairman and CEO, "We are seeing an anomaly ... to understand, not only by the Company, but shareholders ...
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, Inc., ... development and manufacturing of collagen and mineral based ... today that Bill Messer has joined ... to further leverage the growing portfolio of oral ... Bill joins the Collagen Matrix executive ...
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the ... In terms of the latter, setting the bar too high can result in disappointment, ... just slow progress toward their goal. , Research from PsychTests.com reveals ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are ... for this recognition are considered among the top 2 percent of lawyers practicing within ... of this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Comfort Keepers® of ... Cancer Society and the Road To Recovery® program to drive cancer patients to and ... other adults to ensure the highest quality of life and ongoing independence. Getting ...
Breaking Medicine News(10 mins):