Agenda

7th Annual Medical Device Regulations Conference. Please view the agenda below. Click here if you would like a printable copy of the agenda.

 Wednesday, November 6, 2019 Agenda 
8:30-9:00 AMRegistration/Light Breakfast
9:00-9:15 AMWelcome/Conference OverviewAl Jacks III, Vero Biotech
9:15-10:00 AMFDA CDRH Reorganization & Update on OPEQJoshua Nipper, FDA – OPEQ
10:00-10:45 AMFDA ORA UpdateAnne Reid, FDA -ORA
10:45-11:15 AMMorning Break
11:15-12:00 PMMedical Device Single Audit Program update: Industry perspectiveBryan Brosseau, Brosseau Consulting LLC.
Melinda Smith, Neomed Inc.
12:00-12:45PMMedical Device Single Audit Program: FDA PerspectiveRhonda Mecl, FDA – ORA
12:45-2:00 PMLuncheon: " Ennov - Your Complete Materiovigilance Solution"
• Dr. Kristen Mandello, Ennov

Luncheon: UGA is pleased to host an FDA employment info session. Come learn more about working for the FDA and have the unique opportunity to speak with an FDA official.
• Kathleen Sinninger, Director, Investigations Branch
2:00-2:45 PMEU MDR status (latest info on implementation)Philippe Etter, Medidee Services SA
2:45-3:30 PMRecent Developments in China Medical and IVD Devices Regulation and the Implications QianQian Zhu, Immucor
3:30-4:00 PM Afternoon Break
4:00-4:45 PMDeployment of Integrated Risk Management System as Decision Making ToolMizanu Kebede, Avanos
4:45-5:30 PMPostmarketing Safety Reporting for Combination ProductsKatie Fisher, Vero Biotech
5:30-5:45 PMWrap-up
6:00-7:30 PM Networking Reception (RSVP Required) Hampton Inn
 Thursday, November 7, 2019 Agenda
8:00-8:15 AMWelcome and Day 2 OverviewDr. Grace Gowda, Director of UGA Regulatory Sciences
8:15-9:00 AMFDA inspectional approachLaiza Garcia, FDA-ORA
9:00-9:45 AMWarning Letter TrendsDavid Van Houten, FDA-ORA
9:45-10:30 AMNotified Body Audits – Challenges and OpportunitiesRalf Gansel, EU
10:30-11:00 AMMorning Break
11:00-11:45 AMPre-submission and Submission –Do’s and Don’tJoshua Nipper, FDA-OPEQ
11:45-12:30 PMRegulatory Pathways for Biological Medical DevicesAnna Fallon, Consultant
12:30-1:30 PMLuncheon: "Network Partners – Company Overview and the Regulatory Affairs Apprentice Program"
• Ratinder Dhami, Director of Regulatory Affairs, Director of Regulatory Affairs
1:30-2:15 PMArtificial Intelligence and Machine learning Software on Regulatory Strategy for Medical devicesScott Thiel, Navigant
2:15-3:15 PMPanel Discussion- "Ask the Regulators"Moderator: David W. Mullis, Jr.
3:15-3:30 PMClosing RemarksDean Kelly Smith, UGA COP