If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.

This audio conference covers:

• IVD regulatory terminology pharma companies should know
• The differences between FDA risk classifications
• Aligning your drug and diagnostic development timelines
• How the changing regulatory landscape can impact your product strategy

About the speaker:

David Kern, RAC MBA is Senior Director with Myraqa, a full-service IVD regulatory consulting firm. Dave has nearly 20 years of experience developing IVD and life science products. His experience in product development, project management, business development and relationship management grants him a wide view of the entire lifecycle management process. He has designed and implemented product development processes for both FDA and ISO environments, in both large and small companies. He also has extensive experience in creating and implementing governance structures to manage co-development and outsourcing relationships within both the IVD and therapeutics industries.

Dave holds a BS in Biochemistry from San Francisco State University, and an MBA from San Jose State University. He has extensive training in project management, facilitation and conflict resolution, and holds a Regulatory Affairs Certification.

Who should attend?

• Regulatory Affairs Directors
• Quality Directors
• Clinical Affairs Directors
• Development Directors
• Project Management Directors
• Marketing Directors
• Business Development Directors