Navigation Links
The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation? New Life Science Webinar Hosted by Xtalks and IRB Services
Date:1/14/2014

Toronto, Canada (PRWEB) January 14, 2014

In recent years, growing suspicion about the pharmaceutical industry and its motives and methods in product development and promotion has led to unprecedented levels of public mistrust of the industry. This mistrust, fueled by concerns about the insidious impact of commercialization of research, has been further fed by reports of spectacular fines to the world’s biggest pharmas for illegal marketing activities, allegations of industry suppression of negative clinical trial results, and fears of “influence peddling” through physician payments of various sorts.

The Physician Payments Sunshine Act (“The Sunshine Act”) is the US Congress’s response to these concerns. The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals.

Manufacturers are required to collect and track payment, transfer and ownership information beginning Aug. 1, 2013. Manufacturers will submit the reports to the Centers for Medicare & Medicaid Services (CMS) on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members. The majority of the information contained in the reports will be available on a public, searchable website.

These new reporting requirements have imposed a considerable burden on all concerned, including IRBs, sponsors, CROs, clinical investigators, and certainly government. Will this added regulatory burden prove effective in promoting more ethical research with improved outcomes for patients and society?

For more information about this event or to register, visit The Sunshine Act: Necessary Regulation or Unnecessary Dysregulation.

About IRB Services
Founded in 1993, IRB Services is an independent organization dedicated to protecting the rights and safety of human research subjects. As one of the largest central institutional review boards in North America, IRB Services is an experienced, service-driven organization dedicated to excellence in human research participant protection and committed to providing industry leading efficient customer-oriented services. IRB Services provides ethical review of clinical trials and behavioral science research and operates ethics committees in Boca Raton, Florida; Montréal, Québec; and Toronto, Ontario; which review a wide range of both industry and publicly funded human subject research across multiple disciplines, including Food and Drug Administration, US Department of Health and Human Services, and Health Canada regulated research. IRB Services has received full accreditation from the Association for the Accreditation of Human Research Protection Programs. For more information please visit http://www.irbservices.com.

About Xtalks
Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks, visit http://xtalks.com/ContactUs.ashx.

Contact:
Michelle Tran, Marketing Manager
(416) 977-6555 ext 224
mtran(at)xtalks(dot)com

Read the full story at http://www.prweb.com/releases/2014/01/prweb11483959.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Clinverse, Inc. Introduces ClinSpend to Meet Challenges of Sunshine Act Reporting Requirements
2. Drug Advertising and Promotion Labeling: FDA Regulations, New Webinar Hosted by Xtalks
3. Online Courses Address Latest Healthcare Compliance Regulations
4. CfPIE Announces Advisory Board to Support Continued Life Sciences Training Alignment with Industry Regulations
5. Study dusts sugar coating off little-known regulation in cells
6. Swiss, EMA, US Pharmacopoeia and World Health Organization Authorities to Provide an Update on Cool Chain Regulations
7. Gordon Hunter's New Science Book Perfect for the Everyday Environmentalist
8. Bayer CropScience Reveals Insights into U.S. Potato Industry’s Top Needs for 2014 During Potato Expo
9. Isolation Sciences’ CAP Device Found to Reduce Energy Use by More Than 80 Percent
10. Fibrocell Science and Intrexon Expand Collaboration to Include Hypermobility-Type Ehlers-Danlos Syndrome
11. Science Magazine: Cancer Immunotherapy is the Medical Breakthrough of 2013; The CBCD Highlights the Link between Immunotherapy and Microcompetition
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/30/2016)... TORONTO , Nov. 30, 2016 /PRNewswire/ - Portage ... Canadian Securities Exchange: PBT.U), is excited to announce ... company focused on developing preclinical ophthalmology assets through ... a potent anti-inflammatory created by Portage Pharmaceuticals Limited ... patients with ocular surface and anterior segment diseases. ...
(Date:11/30/2016)... CHICAGO , Nov. 30, 2016  Tempus, ... customized cancer care, and Penn,s Abramson Cancer Center ... have a positive response to immunotherapy treatment based ... As part of a research collaboration, ... pancreatic and melanoma cancer patient data to Penn. ...
(Date:11/30/2016)... 2016   Merck , a leading science and ... a set of agreements with Evotec AG, whereby Evotec ... genetic reagents such as CRISPR and shRNA libraries. Combining ... an accelerated pathway to explore and identify new drug ... of new targets, a process that can be time- ...
(Date:11/30/2016)... ... 2016 , ... On 28 November 2016, the International Union of Pure and ... moscovium (Mc), tennessine (Ts), and oganesson (Og), respectively for element 113, 115, 117, and ... the discoverers have been approved by the IUPAC Bureau. The IUPAC Council will be ...
Breaking Biology Technology:
(Date:11/29/2016)... Nov. 29, 2016   Neurotechnology , ... object recognition technologies, today released FingerCell 3.0, ... recognition solutions that run on low-power, low-memory ... using less than 128KB of memory, enabling ... that have limited on-board resources, such as: ...
(Date:11/28/2016)... 28, 2016 "The biometric ... 16.79%" The biometric system market is in the ... the near future. The biometric system market is expected ... at a CAGR of 16.79% between 2016 and 2022. ... biometric technology in smartphones, rising use of biometric technology ...
(Date:11/22/2016)... According to the new market research report "Biometric System Market by Authentication ... (Hardware and Software), Function (Contact and Non-contact), Application, and Region - Global ... from USD 10.74 Billion in 2015 to reach USD 32.73 Billion by ... Continue Reading ... ...
Breaking Biology News(10 mins):