2016 AMDM Annual Meeting Agenda

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2016 AMDM Annual Meeting Agenda
Wednesday
April 20, 2016
11:00 a.m. – 5:45 p.m.
11:00 – 11:15 a.m.
Welcome
Karin Hughes, AMDM President Donna Link, Karen Richard, Annual Meeting Co‐Chairs 11:15 – 12:15
Roundtable Discussion with OIR Management Team
Alberto Gutierrez, Ph.D., Director, Office of In Vitro Diagnostics and Radiological Health, FDA Room:
White Flint
Amphitheatre
[email protected]
12:15 – 1:15
Lunch
1:15 – 2:00
IVD Industry Overview
Susan Tiedy‐Stevenson, Sr. Director of Reg. Sciences, Hogan Lovells [email protected] 2:00 – 2:30
ISO 13485 Update
Stefan Burde, IVD Product Expert, BSI Americas [email protected] 2:30 – 2:45
Break
2:45 – 3:15
Two New Developments: Promoting IVDs and FDA
Regulation of LDTs
Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara [email protected] 3:15 – 3:45
How Western IVD Manufacturers Can Succeed in Asia
Ames Gross, President, Pacific Bridge [email protected] 3:45 – 4:00
Break
4:00 – 4:40
De-Identified Specimens and Implications of Proposed
Rulemaking—What You Need to Know
SKhatereh Calleja, JD, Sr. VP Technology & Reg. Affairs, AdvaMed [email protected] 4:40 – 5:20
MDSAP Update
tba 5:20
AMDM Annual Business Meeting
immediately followed by our
Welcome Reception
White Oak A
2016 AMDM Annual Meeting Agenda
Thursday
April 21, 2016
9:00 a.m. – 3:15 p.m.
8:00 –9:00 a.m.
Complimentary Breakfast Buffet
9:00 – 9:45
The Changing Regulatory & Policy Environment for
Diagnostics - What to Expect in 2016 and Beyond
Thomas Soriano, President, DOCRO White Flint
Amphitheatre
[email protected]
9:45 – 10:30
Personalized Medicine Update
Liz Mansfield, OIR, CDRH, FDA [email protected] 10:30 – 10:45
Break
10:45 – 11:30
Direct to Consumer Testing
FDA speaker invited 11:30 –12:00
De Novo Process Update (incl. Expedited Access Program)
FDA speaker invited
12:00 – 1:00
Lunch 1:00 – 1:45
Changes to the IVD Regulations in Europe
Stefan Burde, IVD Product Expert, BSI Group [email protected]
1:45 – 2:25
Impact of the Upcoming Changes to the IVDR:
Meeting New Clinical Evidence Requirements
Carol Ryerson, Principal Advisor, RCRI [email protected]
2:25 - 3:00
Factors to Consider When Making Benefit-Risk
Determinations in Medical Device Premarket Approvals
and De Novo
tba 3:00 - 3:15
Review & Wrap Up
Karin Hughes, Donna Link, Karen Richards, Annual Meeting Co‐Chairs White Oak A

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