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PMA Submissions Workshop - Spring 2020

February 27, 2020 to February 28, 2020
Irvine, CA
Regulatory
Workshop

Completing the set of interactive submissions workshops, industry and FDA experts will lead you through the strategic considerations and practical steps of filing a Premarket Approval.

Agenda topics include:

  • Steps to develop a PMA submission strategy
  • Best practices of quality system information for PMA applications
  • What to expect during a submission review
  • Preparation needed for an advisory panel meeting
  • Tips to prepare for an inspection
  • Ins and outs of BIMO inspections
  • How to deal with unexpected clinical outcomes, animal test results, and adverse panel recommendations
  • Needed supplemental submissions for approved PMAs
  • Real world case studies
  • And more!

View the full agenda

Download the full agenda

Feb 27, 2020 

8:30 – 9:00 am

Registration Check-In and Continental Breakfast

9:00 – 9:05 am

Welcome and Introductions

9:05 – 10:00 am

Beginning at the Beginning
Gerry Prud'homme, Hogan Lovells 

  • When is a De Novo or PMA required
  • PMA:  what to expect
    • What are the standards of evidence
    • What are the standards of review
    • Will submission go to panel
    • How much will it cost
    • How long will it take to get approval

10:00 – 10:45 am

Development of a PMA Submission Strategy
Joshua Nipper, FDA

  • Product definition
  • Development of testing requirements and strategy
  • Desired patient population
  • Desired claims
  • Early interactions with FDA
  • Planning for product iterations

10:45 – 11:00 am

Break

11:00 – 12:00 pm

Mechanics of PMA Quality System Submission Development and Review
Megha Reddy, FDA

  • Defining data requirements
  • Required elements
  • Presentation of information with clarity
  • Expectations during review
  • Best practices
  • Manufacturing & Quality Systems
  • Case for Quality

12:00 – 1:00 pm

Networking Lunch

1:00 – 1:45 pm

During Submission Review
Jennifer Bolton, Boston Scientific

  • Interactions with the FDA
  • When/How to expect questions
  • Types of letters
  • Timelines
  • Day 100 meeting
  • Labeling review

1:45 – 2:30 pm

Conditions of Approval Studies
Jennifer Bolton, Boston Scientific

  • Criteria and objectives
  • Early collaboration with FDA
  • Reaching agreement
  • Reporting outcomes
  • 522 Studies

2:30 – 2:45 pm

Break

2:45 – 3:30 pm

Preparation for Advisory Panels
Gerry Prud'homme, Hogan Lovells

  • When?
  • Who are the panel members?
  • Why have a panel meeting?
  • Preparation for a panel meeting
  • What to expect before, during, and after
  • Best practices

3:30 – 4:15 pm

BIMO Audits
Christopher Gioffre, FDA 

  • The purpose of a BIMO inspection
  • When and how a BIMO inspection occurs
  • Preventing findings and responding to findings
  • Typical and atypical observations – cautionary tales from the field

4:15 – 5:00 pm

Inspection Activity
Kenneth Chen, FDA 

  • Pre-approval inspections
  • How to prepare for an inspection

5:00 – 6:00 pm

Networking Reception

Feb 28, 2020

8:30 – 9:00 am

Continental Breakfast

9:00 – 10:00 am

Dealing with the Unexpected
Quynh Hoang, King & Spalding

  • Clinical outcomes
  • Animal test results
  • Adverse panel recommendation

10:00 – 10:45 am

The Care and Feeding of Approved PMAs
Joseph Tsai, Dexcom

  • Periodic (“Annual”) Reports
  • Supplemental Submissions
  • 30-day notices

10:45 – 11:00 am

Break

11:00 – 11:45 am

CDRH Ombudsman’s Office – Roles & Responsibilities and the Appeals Process
Ken Skodacek, FDA

11:45 – 12:15 pm

Real World Case Studies
Quynh Hoang, King & Spalding

12:15 pm

Adjournment

  • Gerry Prud'homme, Hogan Lovells
  • Joshua Nipper, FDA
  • Megha Reddy, FDA
  • Jennifer Bolton, Boston Scientific
  • Christopher Gioffre, FDA
  • Kenneth Chen, FDA
  • Quynh Hoang, King & Spalding
  • Joseph Tsai, Dexcom
  • Ken Skodacek, FDA

The PMA Submissions Workshop will take place February 27-28 at the Courtyard Irvine Spectrum in Irvine, CA.

Click here to reserve your room

Room Rate: $199.00
Reservation Cutoff Date: Monday, February 3, 2020

Address:
7955 Irvine Center Drive
Irvine, CA 92618

Registration Fees

AdvaMed Member Registration: $1395.00

Accel Member Registration: $695.00

Government and Non-Profit Registration: $695.00

Non-Member Registration: $1,895.00

Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by February 14, 2020 for $200 off your registration!