Let's face it, risk is a difficult topic; thinking about things that can go wrong is stressful! Managing risks in medical device clinical trial projects can seem daunting, with so many aspects to consider: patient enrollment behind schedule, delays in delivery of study supplies, and more. The clinical trial manager may also need to participate in the product risk management process for the device under study (per ISO 14971), which incorporates clinical evidence from these trials - that process can seem complex to those unfamiliar with it. These 2 risk management processes may seem different, but are in fact grounded in the same basic risk management framework and can be executed with a logical thought process. 

These topics are integrated and explored by PMINJ Life Sciences LCI Chairperson Claudia Campbell-Matland in her article “Managing Risks for Medical Device Clinical Trials and their (Medical Devices) Products” (published September 2018 in MedDevice Online and August 2020 in Society of Clinical Research Associates’ SOURCE Journal).  This Life Sciences LCI virtual event will be an informal discussion - registrants should download the article to read prior to the event, and be able to discuss it with Claudia via Zoom Q&A. Bring your questions and be prepared for a lively discussion on risk! 

In Claudia Campbell-Matland, PMP’s over 25-year full-time career in the in vitro diagnostics (IVD) industry, she managed a variety of business-critical programs - new product development programs from conception to commercialization, product acquisitions, departmental integrations and remediation of Quality System / Regulatory audit deficiencies - and is a subject matter expert on medical device design control and risk management. Now working as an independent consultant, Claudia is leveraging her expertise to assist start-up and small medical device companies with project management and compliance services for new product development, Quality System process remediations and other projects; assisting universities with their research commercialization efforts; and teaching project management classes for university continuing education departments. 

Normal registration: Thru 08 Oct

• $0.00 - PMINJ Chapter members (fee waived for this meeting)
• The link to the virtual meeting will be included in the Registration Receipt
• Download the Zoom app at: https://zoom.us/download