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:
Who Will Benefit:
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.
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.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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