Looking Back at AMDM
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 during my Industry Update on day one.
Here are some key takeaways that I found particularly interesting as we look ahead to 2017:
Effective regulatory strategies will take on a new twist when In Vitro Diagnostic Regulations (IVDR) in the European Union are formally published later this year.
The FDA Pacific Region Compliance Update warned that enforcement trends continue to be rigorous and firms should pay heed to having compliant QM systems. At Beaufort, we see quality management as improving quality across all GxP processes, from personnel education to data integrity.
The FDA announced the publication of the draft guidance document “Principles for Co-Development of an In Vitro Companion Diagnostic (CDx) Device with a Therapeutic Product.” This is a how-to guide that certainly will affect a sponsor’s approach to the CDx paradigm.
FDA also described the guidance document “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices,” which went into effect September 19 and provides new opportunities to sponsors wishing to address the pediatric population.
Beaufort is an industry leader in developing comprehensive regulatory solutions that address the unique needs of clients and products. We have the technical and operational experience to navigate the landscape of challenges and changes and create and manage strategies that result in success for our clients.
Robert Di Tullio is an accomplished regulatory affairs professional with over 40 years’ experience in the in vitro diagnostics industry with the last 28 years focused in regulatory, clinical and quality management. As Beaufort’s Senior Vice President, Global Regulatory Affairs, Robert provides vision, strategic insight and leadership to promote commercial success for our clients while ensuring compliance with global regulations and initiatives.