Co-Chairs

Patricia Kaeding

Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)

Paulette M. Mara

Partner
Michael Best & Friedrich LLP (Washington, DC)

Speakers

Nathan A. Beaver

Partner
Foley & Lardner LLP

Jonette Foy, Ph.D.

Associate Director for Policy (Acting)
Center for Devices & Radiological Health U.S. Food and Drug Administration

FDA Keynote Address: Jonette Foy, Ph.D.

July 27, 2017 9:30 am

Jeffrey Gibbs

Director
Hyman, Phelps & McNamara, PC (Washington, DC)

Sonali P. Gunawardhana

Of Counsel
Wiley Rein LLP (Washington, DC)

Patricia Kaeding

Chief Regulatory Counsel
GE Healthcare (Waukesha, WI)

Tricia Kaufman

Of Counsel
Stinson Leonard Street LLP (Minneapolis, MN)

Quality Systems Regulation and UDI

July 28, 2017 9:30 am

Amanda Klingler

Partner
King & Spalding LLP (Washington, DC)

Recalls and Withdrawals

July 28, 2017 12:00 pm

Dan Kracov

Partner
Arnold & Porter Kaye Scholer LLP (Washington, DC)

Marian Lee

Partner
Gibson, Dunn & Crutcher LLP (Washington, DC)

Stephen Lieb

Partner
Wissing Miller LLP (New York, NY)

Cybersecurity and Digital Health

July 27, 2017 2:30 pm

Kevin Madagan

Partner
Reed Smith LLP (Washington, DC)

Medical Device Reporting

July 28, 2017 10:45 am

Sally L. Maher

VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

Seth A. Mailhot

Partner
Michael Best & Friedrich LLP (Washington, DC)

Brian Malkin

Counsel
Arent Fox LLP (Washington, DC)

Quality Systems Regulation and UDI

July 28, 2017 9:30 am

Christopher Mikson, M.D.

Partner
Mayer Brown (Washington, DC)

Melissa Markey

Attorney
Hall, Render, Killian, Heath & Lyman, PLLC (Troy, MI)

Cybersecurity and Digital Health

July 27, 2017 2:30 pm

Yarmela Pavlovic

Partner
Hogan Lovells US LLP (San Francisco, CA)

Stephanie Philbin

Counsel
Goodwin Procter LLP (Washington, DC)

Medical Device Reporting

July 28, 2017 10:45 am

Nancy Stade

Partner
Sidley Austin LLP (Washington, DC)

Frederick A. Stearns

Partner
Keller and Heckman LLP (Washington, DC)

Recalls and Withdrawals

July 28, 2017 12:00 pm

Stephen Terman

Principal
Olson Frank Weeda Terman Matz, PC (Washington, DC)

Medical Device Reporting

July 28, 2017 10:45 am

Julie Tibbets

Partner
Alston & Bird LLP (Washington, DC)

Gretchen Vandal

Associate Director, Device Regulatory Affairs
Biogen Inc. (Cambridge, MA)

Cybersecurity and Digital Health

July 27, 2017 2:30 pm