Articles/White Papers

  • Highlights from FDA Industry IVD Roundtable December 20, 2016 The fall FDA‐Industry IVD Roundtable Meeting hosted by the Office of In Vitro Diagnostics and Radiological Health (OIR) of the FDA’s Center for Devices and Radiological Health took place in Silver Spring, MD on December 2nd.  Here are a few of the day’s highlights. Post-Election, OIR Halts LDT Oversight Policy In his opening remarks OIR Director Alberto ...
  • Looking Back at AMDM October 19, 2016 I’m just back from AMDM’s 2016 IVD Focus Meeting. This annual event is always exciting as it brings together industry experts and thought leaders to exchange ideas, examine trends, and explore best practices. I was honored to share the stage with many peers and industry professionals over the 2-day conference and provide my perspective on the regulatory landscape ...
  • Beaufort Insights: ExL’s Clinical Quality Oversight Forum October 5, 2016 In view of ExL’s upcoming 7th Clinical Quality Oversight Forum in Philadelphia, Beaufort quality oversight expert John Wilson offers insight into some of the industry’s hot topics. How will the revisions to the ICH E6 GCP Guidelines affect clinical quality oversight? Revision 2 will have significant impact on quality oversight. It is important to note that there ...
  • RAPS Unwrapped September 29, 2016 I’ve just returned from RAPS’ 2016 Regulatory Convergence conference in San Jose, Calif. This year marks the 40th anniversary of RAPS’ formation to help establish the regulatory profession as a critical and distinct discipline. Today RAPS is known for bringing together regulatory industry experts and thought leaders to exchange ideas, examine trends, and explore best ...
  • The Changing Regulatory and Policy Environment for Diagnostics: What to Expect in 2015 and Beyond June 3, 2015 Your browser does not support the video tag. “What’s past is prologue.” —The Tempest, Shakespeare If there’s one thing that history teaches us, it’s that history repeats itself. To get a picture of what the regulatory landscape will look like tomorrow, it’s important to understand what it looked like yesterday, and how we got to where ...
  • Spring AMDM in Review May 8, 2015 The Association of Medical Diagnostics Manufacturers (AMDM) held its annual meeting April 22-23, with an OIR Submissions workshop and Pre-Submissions workshop April 20-22.  The two workshops were “FDA 101” for regulatory professionals, with the majority of speakers being from the FDA and covering all aspects of OIR submissions.  But, even for seasoned regulatory professionals, there ...
  • FDA / CMS Task Force on LDT Quality Requirements Is a Step in the Right Direction April 30, 2015 FDA recently announced that FDA and CMS will form a task force to focus on the quality requirements of laboratory developed tests (LDTs). The overall goals of the task force are to clarify the roles of the two agencies and avoid a duplication of efforts. Last fall, FDA released two draft guidance documents here and here ...
  • Five Steps For Improving Processes In Clinical Trials January 8, 2015 In “Five Steps for Improving Processes in Clinical Trials,” Beaufort’s John Wilson introduces the five-step process for improving business processes.  The article provides an introduction to the five steps, using risk-based monitoring (RBM) as an illustrative example. Wilson states that only after completing the first four steps (map, analyze, redesign, and assign resources) can we productively move ...
  • Some Quality Food For Thought October 5, 2012 In “Some Quality Food for Thought,” Beaufort’s John Wilson questions why quality improvements in clinical research are so slow to come about. Wilson suggests that the industry commit to systematic, practical and measurable applications of basic principles and he cites four areas that often are overlooked. This article appeared in the October 2012 Journal of Clinical Research Best Practices.
  • Quality By Design: Manufacturing Has It Right May 1, 2012 In this article from the May 2012 issue of the Journal of Clinical Research Best Practices, Beaufort’s John Wilson argues that clinical research can benefit from QBD. Pharmaceutical manufacturing established a risk-based approach to quality more than a decade ago, yet its adoption in clinical trials has been slow. As the pressure for fundamental change ...