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Premarket Submissions Workshops

A succinct set of programs run by seasoned industry experts teaches the regulations, procedures, best practices, and strategies for medical device and diagnostics premarket submissions. Attendees will learn how to plan and allocate resources for submissions, meet effectively with FDA, develop the requisite evidence and assemble the application, and also understand the FDA review process and appreciate the relationship between regulatory strategy and a company’s overall business strategy.

Each workshop is one day (separate registration fee), and attendees will receive discounts when they register to attend multiple workshops in a single city.

These small format, highly interactive workshops ensure that attendees will get the information and answers they need.

What you will learn:

  • Regulatory requirements for premarket submissions
  • The process of 510(k) clearance and de novo 510(k)
  • Determining and demonstrating substantial equivalence
  • The process of PMA submissions
  • Constructive pre-submission meetings with FDA
  • Clinical and evidentiary requirements
  • Assembling a PMA application
  • FDA review procedures
  • Procedures for FDA Advisory Panels
  • Planning a submission strategy
  • Identifying and coordinating resources for submissions
  • Coordinating business and regulatory strategies

Who should attend:

Medical device and diagnostics company regulatory, clinical, and R&D professionals and others requiring a thorough working knowledge of FDA requirements and best practices for effective premarket submissions

Speakers:

  • Tony Blank - Co-Founder, Barton & Blank
  • Chris Brauer - Principal, Brauer Device Consultants
  • Michael Santalucia - VP, Global Regulatory Affairs, TerumoBCT
  • Lina Kontos - Counsel, Hogan Lovells
  • Yarmela Pavlovic - Partner, Hogan Lovels
  • Majorie Shulman - Chief, Premarket Notification (510(k)) Section, CDRH, FDA (invited)
  • Joshua Nipper - Chief, Premarket Approval Staff, CDRH, FDA (invited)
    other industry speakers TBA

CEU Information

Attendees can earn CEUs. 1 hour of the conference = .1 CEU. MedTech Intelligence will provide you a Certificate of Attendance with the amount of CEU's earned about three weeks after the conference.

MedTech Intelligence's conference CEUs can be applied to your Regulatory Affairs Certification.

Details

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