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:2/9/2016)... Blood Monitoring & Cardiac Monitoring Devices Market Assessment & Forecast: 2015-2019" ... market for blood monitoring & cardiac monitoring devices was valued at ... 24,830.1 million by 2019 at a CAGR of 6.8% from 2015 ... Europe , Asia-Pacific , Latin ... Africa . The three major factors determining growth of the ...
(Date:2/9/2016)... , Feb. 9, 2016 The life of Dr. ... Center, has been anything but ordinary.  Twists of fate, combined ... War II and the constraints of communist Czechoslovakia to ... he would go on to make history by playing a ... best-selling drugs in the world, Remicade.  Dr. Vilcek brings readers ...
(Date:2/9/2016)... KONG , Feb. 9, 2016 Athenex, Inc. ... Athenex as Vice President of Corporate Strategy and Business Development ... MSc, MBA has joined as Senior Director and Deputy Head of Clinical ... . Simon Pedder stated, "Athenex has ... for a while. Coupled together with their unique business model ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... ... Gout is like no other joint pain. It strikes suddenly, like flicking on ... redness. It is triggered by the crystallization of uric acid within the joints. It ... to the February 2016 issue of Harvard Men's Health Watch. , The large joint ...
(Date:2/10/2016)... ... February 10, 2016 , ... AHRA: The Association for ... speaker Jan Fox will serve as keynote speaker at the organization’s 2016 Spring ... tools to more effectively communicate with their own organizational staff and leadership. ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... will attend the Ohio Safety Congress and Expo event March 9-11, 2016. Hosted ... Greater Columbus Convention Center. , As the longest running and largest worker's ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... biocompatible columns and accessories. These PEEK-lined stainless steel (PLS) columns combine the strength ... solution that ensures the integrity of biological samples while operating at ultra-high pressures ...
(Date:2/10/2016)... CA (PRWEB) , ... February 10, 2016 , ... Workrite ... based company that has evolved from humble beginnings to being an internationally recognized leader ... company that we are today”, said Charlie Lawrence, President of Workrite. “Workrite recognized ...
Breaking Medicine News(10 mins):