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Interacting with FDA and Regulatory Bodies
Planning an FDA medical device submission?

Former FDA Team Leader and current PAVmed Inc. Vice President, Regulatory and Quality, Deepika Lakhani, and StarFish Medical Vice President of QA/RA, Nicole Ouellet share strategies and lessons from their years of delivering and evaluating medical device submissions to FDA and other Regulatory bodies.

Topics include:

• Lessons learned from a former FDA reviewer
• Regulatory pathways that enable innovation
• De novo case study
• Regulator pre- meeting briefing document tips
• Key stakeholders for a pre-submission meeting
• Positioning pre-submission meeting questions

Scott Phillips, Medical Device Playbook and StarFish Medical Founder, hosts and moderates live audience Q&A with presenters.

#MDPLAYBOOK

Average audience rating for Medical Device Playbook events: 9/10! “Honestly, I am very impressed with the caliber of guests and topics covered today. Keep up the good work.”

01:25:00

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Speakers

Deepika A. Lakhani
Vice President of Regulatory & Quality @PAVmed Inc.
Deepika A. Lakhani serves as the Vice President of Regulatory & Quality, at PAVmed Inc. Prior to her current role, Deepika was at AstraZeneca Pharmaceuticals in Global Regulatory Affairs and has also spent nearly 11 years at the FDA where she started as a reviewer in Center for Drugs Evaluation and Research (CDER) and subsequently served in multiple positions in CDER and Center for Devices and Radiological Health (CDRH) involved with the review of medical devices, drugs, biologics, and combination products. Deepika considers regulatory affairs to be a creative process that enables innovation. She has multiple peer-reviewed publications and received many awards for excellence and leadership while at the FDA. She holds a Ph.D. in Pharmaceutics from Virginia Commonwealth University.
Nicole Ouellet
Vice President of Regulatory Affairs and Quality Assurance @StarFish Medical
Nicole Ouellet is the Vice President of Regulatory Affairs and Quality Assurance at StarFish Medical. As a seasoned professional with over 20 years of experience in the MedTech industry, she has a proven track record for developing robust regulatory strategies and obtaining global approvals for novel and complex devices. She has worked on submissions for diverse product portfolios including drug device combination products, active implantables, cardiovascular, endoscopy, and neurology devices during her experiences at Boston Scientific, Medtronic, Abbott and most recently Cardinal Health. She is passionate about helping organizations navigate complex regulatory landscapes and finding pathways for successful market access. Nicole holds a B.Sc. in Biomedical Science and a M.Sc. in Nutrition & Toxicology from the University of Guelph, Ontario, Canada. She is based in Toronto Canada.
Scott Phillips
Founder & CEO @StarFish Medical
Scott holds a degree in Engineering Physics from the University of British Columbia. Prior to starting StarFish, he worked in diverse areas such as lithium battery development and manufacturing, UV spectroscopy instrumentation and hi-fi audio speakers. Under his leadership StarFish has grown into a diverse professional organization with clients around the world and 100% focus on medical devices. Scott is a past Chair and current member of the LifeSciences British Columbia board, member of the 2022 VIATEC Board of Directors, Fellow of The Canadian Academy of Engineering, winner of the EY Entrepreneur Of The Year™ 2017 Pacific Awards Technology category, 2017 recipient of the VIATEC Technology Champion award, and volunteers with Junior Achievement, Entrepreneurs Organization, and University of British Columbia.