Regulatory Compliance and Aggregate Spend Solutions
for the Life Science Industry.
  • Press
  • Press
  • Events
  • Links
  • White Papers
  • Links
  • Links

industry news

Thursday, March 24, 2011

QPharma CEO Honored as “2011 Distinguished Citizen” by Boy Scouts of America
Morristown, NJ – March 24, 2011- Patrick P. Den Boer, CEO, QPharma, Inc. will be honored as the 2011 Distinguished Citizen by the Boy Scouts of America, on Wednesday, May 4, at the Morris County Golf Club, Convent Station, NJ.

Monday, March 7, 2011

Clarification of FY11 Guide to Vermont's Prescribed Product Gift Ban and Disclosure Law and FY11 Guide to Vermont's Law on Disclosure of Samples
Clarification of FY11 Guide to Vermont's Prescribed Product Gift Ban and Disclosure Law and FY11 Guide to Vermont's Law on Disclosure of Samples

Wednesday, January 26, 2011

Process Validation Guidance Finalized
The long awaited Process Validation Guidance has been finalized. Click the link below to see the guidance.

Thursday, October 14, 2010

Vermont: Update of Samples Guide and Data Submissions
Vermont will be providing updates to the 2011 Guide on Samples and reporting forms to be available in December.

Wednesday, October 13, 2010

Vermont Disclosure of Samples Conference Call Notes
On October 12, 2010, a conference call was held with Wendy Morgan, Chief Public Protection Division, Office of Vermont Attorney General on the 2011 Guide to Vermont's Law on Disclosure of Samples of Prescribed Products and Draft Sample Disclosure Form.

Monday, October 11, 2010

Vermont 2011 Guide to Disclosure of Samples Available
The draft of the Draft 2011 Guide to the Disclosure of Samples is now posted on the Vermont Attorney General’s website, along with a draft reporting form.

Tuesday, September 7, 2010

Pharmaceutical Commerce: Extend Sampling Programs With Telemarketing and Direct Mail
A biopharma marketer uses direct mail and a call center to access hard-to-reach physicians

Tuesday, June 8, 2010

Deadline Approaches - Submission of Massachusetts Disclosure Report
The pharmaceutical industry, in a number of states, is currently required to track and in some cases, report on promotional activities, such as gifts, meals, consulting fees, and grants provided to healthcare professionals. These disclosures consist of the value, nature and purpose of gifts, payments, or other economic benefits provided to healthcare professionals in the advancement of a drug product or service. It is vital that all companies understand and comply with current marketing and advertising disclosure laws. With the state’s first disclosure report due in less than one month, it is critical that companies understand the Massachusetts reporting requirements for physician payments.

Wednesday, June 2, 2010

Vermont Passes Legislation
On May 27, 2010, Vermont Senate Bill 88 An act relating to health care financing and universal access to health care in Vermont (S.88) became law, without the Governor’s signature. Among other things, S.88 amends Vermont's Pharmaceutical Marketing Disclosure Law by requiring manufacturers of prescribed products to disclose to the Vermont Attorney General's Office all free samples of prescribed products provided to health care providers during the preceding calendar year. The bill authorizes the Vermont Attorney General to publicly report aggregated sample distribution information.

Thursday, May 20, 2010

FDA Training Videos: Introduction to Device Software Regulation
The Food and Drug Administration (FDA) has posted its first CDRHLearn video presentation on software regulation. The presenter is one of FDA's Software Compliance Experts John Murray. This is the first of several software training modules.

Tuesday, May 18, 2010

FDA To Audit Pharma's Electronic Recordkeeping
In a bid to evaluate the pharmaceutical industry's compliance with a regulation known as 21 CFR Part 11, which is all about the growing and vast use of electronic records, the FDA is about to begin a series of so-called inspectional findings at many drugmakers.

Monday, May 17, 2010

QPharma's Spring 2010 Newsletter
Click here to download our Spring 2010 newsletter

Thursday, April 22, 2010

WHO Invites Comments on Draft Guideline

Wednesday, March 31, 2010

New ISPE GAMP®Good Practice Guides now available

Tuesday, March 23, 2010

H.R. 3590: Patient Protection and Affordable Care Act
President Barack Obama signed the health care reform bill (HR 3590 - Patient Protection and Affordable Care Act) into law at the White House on Tuesday, March 23, 2010