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.
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.
Speakers
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.
