The National Security Commission on Emerging Biotechnology (NSCEB) was established by Congress in 2022 as part of the National Defense Act. The NSCEB was tasked with conducting a thorough review of how advancements in emerging biotechnology and related technologies will shape current and future activities of the Department of Defense. This fireside chat between Michelle […]
As the former director of the Center for Biologics Evaluation and Research at the FDA, Peter Marks, MD, PhD, discusses new drug and biologic developments that also gave him insight into what is coming in the future. […]
Halia Therapeutics CEO David Bearss, PhD, Mark Ott, MD, dean of the BYU School of Medicine, and Bob Carter, MD, PhD, CEO of University of Utah Health, discussed how the healthcare system will deal with the upcoming “silver tsunami.” […]
Michelle Holyoak and Jacey Skinner discussed several topics affecting the life sciences industry, including FTC policy around non-compete agreements, regulating pharmacy benefit managers, regulation of mergers and acquisitions, and other policies affecting the industry. […]
Utah’s fast-growing life sciences industry creates opportunities for careers in multiple fields, including regulatory affairs, quality, and compliance. RCQ professionals play a crucial role in ensuring the safety, efficacy, and quality of medical devices, diagnostics, and pharmaceutical products. The session focused on regulatory and quality career pathways as shared by local leaders in the discipline […]
Quality systems are essentially an organization’s business system. There are three core QMS systems that must be working well and interrelated within an organization to continuously improve, prevent bureaucracy, and reduce costs. This interactive session examines how these three core systems work together. […]
Utah’s academic centers are playing an important role in developing regulatory affairs professionals who can facilitate the processes and requirements involved in bringing highly regulated products, such as medical devices, diagnostics, and drugs to market. The session discussed regulatory affairs programs offered by the University of Utah and Weber State University. […]
The session focused on the challenges in quality and regulatory efforts around cybersecurity and human factors in GxP Training and Onboarding. Challenges can stem from the potential for hackers to exploit vulnerabilities in connected devices, impacting patient safety. Human factors considerations in training and instruction are easily overlooked and yet are critical to proper product […]
This presentation provided a comprehensive overview of the FDA’s medical device presubmission process, a critical step for manufacturers seeking to efficiently bring safe and effective devices to market. This session examined the strategic advantages of utilizing the presubmission program (Q-Sub), outlining key components and benefits. […]
Utah continues to receive accolades for its business and startup-friendly environment, and the state’s support for industry, including the life sciences. This session focused on the many resources and initiatives offered by the State of Utah, but specifically developments at the Point of the Mountain and within Utah Inland Port that will facilitate growth in […]