Each year, the FDLI conference in Washington, DC is a valuable opportunity to interface with industry leaders and participate in a multitude of educational sessions. With this year’s conference rapidly approaching, we look forward to the learning opportunities we will undoubtedly experience.
A major topic of interest this year is the resignation of Dr. Scott Gottlieb, the FDA commissioner. In the wake of his departure, it will be interesting to see how members of the FDA will handle the keynote address – typically given by Dr. Gottlieb. In addition, hearing how the FDA will address his replacement and understanding any subsequent changes to initiatives is important to continue providing expert guidance, consulting talent, and project solutions for our clients in this space.
Of the myriad of topics covered this year, the breakout session on Innovative Medical Product Technologies, Novel Products, and FDA Regulation is one of high interest. Technology is an integral and growing part of the industry, and manufacturers and firms alike are working to integrate new, innovative technologies into their products. According to the FDLI’s site, the FDA is strategizing ways to “regulate these emerging technologies without compromising innovation or delaying the next generation of technology to patients in need.” It will be fascinating to hear about these advancements from the perspective of those from within the agency.
The FDA Center for Biologics Evaluation and Research (CBER) Session is another fascinating session that will highlight the new advances and updates in biologics and the biosimilars landscape.
Gaining insights directly from the FDA, furthering our expertise on current and future regulations, and staying up-to-date on new technologies and trends impacting the food and drug industry is an extremely important part of how we deliver The Right Talent. Right Now®. The current European medical device regulations (EU MDR, IVDR) are complex, and the deadlines are fast approaching. As a result, more and more organizations that specialize in manufacturing medical devices are working with consultants to assist with strategic planning to ensure they take the necessary steps to achieve compliance. The Oxford team strives to have a deep understanding of the needs related to these regulations as this allows us to continue partner with the highest caliber consultants with specialized skills. The topics covered at FDLI will provide our team with a more robust understanding of these regulations and equip us to better serve our clients as a whole.