QPharma Case Study: DTP Program Review and Evaluation
The client is a mid-sized pharmaceutical manufacturer that is engaged in the promotion and sampling of prescription drugs across multiple product lines. The client contracted QPharma to evaluate its Direct-to-Practitioner (DTP) program for compliance with the Prescription Drug Marketing Act (PDMA), and to identify any program deficiencies.
Dissecting Electronic Signatures for the Life Sciences
QPharma enjoys a longstanding reputation for the expertise of its personnel on the topic of 21 CFR Part 11 and electronic signatures for the life sciences industry. In this article, featured in the January 2016 edition of Journal of Clinical Research Best Practices, QPharma Director of IT Compliance Robert Finamore and co-author John Harris outline the requirements for electronic signatures in conducting clinical trials.
QPharma Case Study: Effective Alternative Sampling
QPharma is a leader in the delivery of top-quality hand-carry and sample-send (Direct to Practitioner) sampling programs. But it is equally important that pharmaceutical companies implement effective alternative sampling programs to target low-decile, no-see, and other “white space” healthcare practitioners. In this short case study, QPharma Director of Patient Access Michael Milunec outlines a sampling obstacle one of our life sciences clients was facing, and the solution QPharma implemented to solve its brand challenges.
Using “Knowledge Mobilization” to Motivate a Pharma Sales Team
QPharma Chief Medical Officer Dr. Peter Shaw recently developed and conducted a sales force training at a pharma client’s National Sales Meeting. The training was based on a comprehensive physician survey to gain an improved understanding of physician communication preferences. This brief white paper describes the problem our client faced, and QPharma’s effective solution.
QPharma Subject Matter Experts Featured in Online Radio Interview
Scott Collins and Paul Melamud of QPharma’s Professional Services group were recently interviewed on the topic of manufacturing facility and equipment compliance. The online radio interview is featured on Pharmaceutical Online and will be broadcast at the INTERPHEX conference in New York City on March 18 – 20. Hear the interview now.
QPharma’s Sunshine Act Survey Featured in Pharmaceutical Commerce
A survey conducted by QPharma to gauge physicians’ understanding of the Physician Payment Sunshine Act was highlighted in the November/December 2013 issue of Pharmaceutical Commerce. The findings were presented at the PDMA Sharing Conference, which was held in Baltimore in October.
QPharma’s Medical Device Division Offers Guidance on UDI Final Rule
On Friday, September 20, the final Unique Device Identifier (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement. Read more ….
A Comparison of Process Validation Standards
Jeff Boatman, QPharma’s Senior Subject Matter Expert, Medical Devices and Quality Systems, has authored an article titled “A Comparison of Process Validation Standards” that is featured in the May/June issue of Pharmaceutical Engineering, the technical journal of the International Society for Pharmaceutical Engineering.
The Sunshine Act Has Been Finalized … What Has Changed?
In February 2013, the Center for Medicare and Medicaid Services released the final rule of the Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, or medical supplies to disclose transfers of value to physicians and teaching hospitals. Read More ….
Investing in Compliance
You’ve probably taken an online compliance training course at one time in your career. Did you click through in record time, then try your best to pass the assessment? Don’t be ashamed if your answer is “yes” — you aren’t alone. Read More ….
QPharma White Paper: GHTF and FDA Validation Guidance
QPharma’s Jeff Boatman, CQA, Senior Subject Matter Expert, authored a white paper examining the Global Harmonization Task Force’s process validation standard and how it compares to current best practices and FDA regulatory requirements for medical devices.