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Successfully Navigating The FDA Regulatory Process
Recording
Event Description
When a medical device or pharmaceutical is brought to market, navigating the FDA regulatory process is one of the major challenges. This virtual program will give attendees the opportunity to hear from experts with extensive experience helping clients overcome the challenges that they faced.
- Mike Drues will speak about the preparations that should be made before applying to the FDA.
- Kanchana Iyer will speak about actual challenges encountered by applicants during the FDA evaluation process.
- Eric Sugalski will speak about the commercial factors that drive key regulatory and product development decisions.
Agenda
5:00 – 5:30: Attendee Pre-Forum Networking
5:30 – 6:30: Presentations and Q&A
6:30 – 7:00: Post-Forum Networking / Meet the panelists
Venue – Online Event
THE ZOOM LINKS WILL BE PROVIDED AT THE BOTTOM OF THE REGISTRATION PAGE AND BY EMAIL ON THE DAY OF THE FORUM
Tickets- FREE TO ALL
Panelists
Michael Drues, PhD
President,
Vascular Sciences
.
Vascular Sciences is an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical, and biotechnology companies. These include regulatory strategy and intelligence, submission design, and FDA presentation preparation and defense.
Kanchana Iyer, MS
Senior Consultant, Regulatory Affairs
Halloran Consulting Group
Kanchana Iyer is a regulatory affairs professional in the medical device industry, focusing on regulatory and development strategies for innovative hardware, software, and combination device-drug products. She believes successful interactions with regulators arise from a comprehensive approach to development that incorporates risk management, an understanding of design, and regulatory science.
Eric Sugalski, MBA
Founder & CEO,
Archimedic
.
Eric’s background combines medical device design, regulatory affairs, and business strategy. He has deep experience in all phases of product development, from concept formation through design control, V&V, and manufacturing ramp.
Scott Phillips
Founder and CEO, StarFish Medical
MODERATOR
StarFish is Canada’s leading Medical Device Design service provider with a full complement of design, development, and manufacturing services. They help innovative companies create breakthrough products for a number of medical specialty areas. Their proprietary Pathfinder™ process enhances technical engineering and product development. Prototype and volume production are delivered in ISO 13485 certified facilities with class 10,000 clean room capabilities.
David N. Nussbaum
DPM, DABFAS
FORUM ORGANIZER
David is a board-certified podiatric physician with extensive patient care experience as well as Python language and software engineering training. He writes White Papers for organizations and is a Biology instructor.