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Sponsored Webcast: Three Real-World Experiences Using a Novel Data Platform

1.0
RAC Credits
Virtual Programs
Tuesday, 26 October 2021 (12:00 PM) - Tuesday, 26 October 2021 (1:30 PM) Eastern Time (US & Canada)

Regulatory and quality work is driven by data. Quality data enhances our analysis and conclusions, helps us reduce time to approval, and can help minimize and manage quality risks. Historically, efficient access to regulatory and quality data has been time-consuming and tedious, with many professionals preferring to use Google over FDA systems.

In this webcast, a panel of regulatory and quality thought leaders will share their real-world experience using a new platform for finding all the data they needed using case studies that illustrate actual challenges and novel data/research strategies.

Topics to be covered include:

  • 510(k) regulatory strategy: optimizing pathways, predicates, timing, and expected testing requirements.
  • Postmarket surveillance: analysis & reporting on safety trends (adverse events) for an implanted cardiac device.
  • Product code policy: assessing the appropriateness of FDA’s proposed premarket notification exemptions.

This program will provide practical insights, new approaches and tools to help you manage your business. A brief demonstration of the Basil software platform will follow the 60-minute presentation.

This event is brought to you by Basil .





Agenda

TBD

Learning Objectives

At the conclusion of the webcast, participants should be able to:

  • Gain new insight into the capabilities and best practices of modern RA/QA research methods
  • Assess the real-world applicability of a new platform for research and discovery
  • Characterize the effectiveness of current research approaches, budgets, and timelines
  • Apply lessons learned to reduce time and enhance completeness of regulatory submissions and post-market surveillance

Pricing Amounts & Deadlines 

Complimentary

Who Should Attend? 

  • Regulatory Affairs Specialists, Managers, Directors and VPs
  • Post Market Surveillance Specialists, Managers, Directors and VPs
  • Clinical Specialists, Managers, Directors and VPs
  • Healthcare Statisticians, Analysts, and Project Managers

Audience Learning Level

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


Speaker(s)

Ross Meisner

Chief Commercial Officer, Basil Systems, Inc.

Ross leads the commercialization of Basil Systems’ SaaS platform, leveraging his 25+ years of leadership in the healthcare and technology industries. Ross was Managing Director leading Guidehouse’s med-tech practice and its Minneapolis office. He joined Guidehouse in 2016 through the acquisition of Dymedex Consulting, which he co-founded in 2007, building Dymedex into the recognized thought leader for Market Development of medical products. Ross is also a speaker and panelist at healthcare industry events and academic programs.

Prior to Dymedex, Ross led Global Market Development at Medtronic, driving targeted growth across geographies. His early history was in consulting (A.T.Kearney) and international technology start-ups in Silicon Valley and Tokyo. Ross holds a BSEE and earned his MBA from the MIT Sloan School of Management. He also enjoys serving on the local School Board, his city's Planning Commission, and various community boards.


Robert G. Hauser MD FACC FHRS

CEO, MHI Ventures LLC

In 2015 Dr. Hauser retired from the practice of cardiology after 47 years.  He is Emeritus Professor of Medicine, Rush University in Chicago, former CEO of Cardiac Pacemakers, Inc. (now owned by Boston Scientific), and Emeritus Senior Consulting Cardiologist, Minneapolis Heart Institute at Abbott Northwestern Hospital.

He is currently CEO of MHI Ventures LLC and a Clinical Investigator specializing in medical device reliability at the Minneapolis Heart Institute Foundation.  Dr. Hauser resides in Medina, Minnesota, with his wife Sally of 60 years.  They have three daughters and four grandchildren.


Kathy Herzog

Regulatory Consultant, Duval & Associates

Kathy Herzog is a Regulatory Consultant at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, and biotech industries. She has worked in the medical device industry for over 30 years, primarily in the areas of product design and development, regulatory, and project/program management activities for class II and III products.

Prior to joining DuVal & Associates, Kathy worked 26 years at Medtronic in various roles and responsibilities including US and International regulatory strategy, premarket submissions, business process improvement, and Medical Affairs.  Kathy holds a Bachelor of Science in Mechanical Engineering from the University of Wisconsin.


Lisa Pritchard

Vice President of Regulatory, Quality, Clinical and Engineering, Duval & Associates

Lisa Pritchard, BSEEE, is VP of Regulator, Quality, Clinical and Engineering at DuVal & Associates, P.A. She works extensively on worldwide regulatory strategies, marketing submissions and applications (FDA submissions such as pre-submissions, IDEs, Breakthrough Device Designations, 510(k)s, De Novos, PMAs, Emergency Use Authorizations, and advisory panel meeting preparation; European Design Dossiers, Technical Files, and Clinical Evaluation Plans and Reports; Canadian license applications; and Australian listing applications); quality system strategies, SOP development and review, and compliance topics.

Prior to joining DuVal & Associates, Lisa executed successful Regulatory, Quality and Compliance strategies at American Medical Systems, Medtronic, Uromedica, and EnteroMedics. She brings over 30 years of experience in strategy development, submission preparation, regulatory body negotiations, advertising/promotional materials assessment, inspection/audit preparation and conduct, quality system design, risk assessment, development of design control documentation, usability evaluations, clinical trial design, and adverse event reporting. Lisa earned her Bachelor of Science, Electrical and Electronics Engineering, from North Dakota State University.


M. Jason Brooke, MSE, JD, CSQE

Medical Device Attorney and RA/QA Advisor, Brooke Consulting, LLC

M. Jason Brooke, MSE, JD, CSQE is the Managing Member at Brooke Consulting, LLC—a digital health legal and regulatory advisory firm. Jason offers a unique, multi-disciplinary perspective on the digital health industry as a regulatory attorney, scientist, technologist, and quality consultant. He brings a focused expertise in the medical device industry that combines nearly 20 years of experience ranging from science and technology design, development, implementation, and testing; to business strategy and operations; to legal and regulatory compliance.

Jason has served as a Director and Global Lead of the Life Science Regulatory, Quality & Patient Safety practice within a multinational management consulting company, where he supported large and small U.S. and international medical device and digital health companies address the challenges that arise across the product lifecycle when commercializing medical devices, mobile/digital health technologies, and clinical decision support software.



Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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