Regulatory Reporting: Building Systems and Processes to Ensure Compliance

Why Should You Attend:

One of the most challenging areas for medical device and IVD companies to manage is regulatory reporting. Regulatory agencies around the world require manufacturers to have systems in place that can quickly and accurately assess whether a complaint is routine or an adverse event. Further, manufacturers are expected to track issues with their devices over time to determine if there is a systemic problem requiring market withdrawal or a formal recall. The systems that manufacturers put in place to handle complaints and assess them for potential regulatory review have to be robust and scalable.

This webinar will go through the requirements and give advice on how to plan and design systems to meet the requirements for regulatory reporting. You will learn concepts and ideas based on real-world experiences that can help them design and implement systems that will make them more effective.

Areas Covered in the Webinar:

• Regulatory reporting requirements for key markets.
• Complaint handling processes and training.
• Key considerations (global markets, distributors, role of authorized reps and notified bodies).
• Regulatory reporting systems – reporting, monitoring, recalls.

Who Will Benefit:

• Customer Service and Support Managers
• Quality Assurance Managers
• Regulatory Affairs Managers
• Field Application Specialist

David Kern
Owner, K2 Regulatory Consulting

Dave Kern has 25+ years in the life sciences and medical device industries, holding positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs and Clinical Affairs at Illumina, where he built a global organization, with offices in China, Australia, and the UK. He also led the regulatory efforts to bring Illumina their first PMA product approval (Extended RAS Panel Test) in 2017.

Dave joined Illumina in 2014 as part of the acquisition of the consulting firm Myraqa. While at Myraqa he worked for five and a half years as a regulatory consultant, collaborating with clients on a variety of projects in the areas of infectious disease, oncology, cognitive disorders and companion diagnostics.

Prior to that, Dave was Director of Program Management at both Adamas Pharmaceuticals and CareDx. He also worked for seven years at Affymetrix, first in Program Management and later in Strategic Alliances. Previous to that he worked at for seven and a half years Chiron Diagnostics, where he was part of the product development team that launched one of the first HIV viral load tests, using Chiron’s bDNA technology.

Topic Background:

From the time a medical device company finds out about a potential adverse event until they need to report it is in most cases five days. During that time the company needs to triage the complaint, elevate it to Regulatory Affairs for review, have Regulatory conduct an assessment, determine the severity and possibility report back to regulatory bodies worldwide while taking market action.

With programs like MDSAP and the interconnectivity of regulatory agencies around the world, there is more focus than ever on regulatory reporting and compliance. With more companies selling their products globally, the speed at which one accurately assesses and reports on regulatory compliance issues like adverse events need to be faster than ever. Understanding how to build compliant systems and processes that scale with your business is essential to regulatory personnel worldwide. This session will focus on the importance of creating systems and processes that work seamlessly together.

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