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 AM||Registration/Light Breakfast|
|9:00-9:15 AM||Welcome/Conference Overview||Al Jacks III, Vero Biotech|
|9:15-10:00 AM||FDA CDRH Reorganization & Update on OPEQ||Joshua Nipper, FDA – OPEQ|
|10:00-10:45 AM||FDA ORA Update||Anne Reid, FDA -ORA|
|10:45-11:15 AM||Morning Break|
|11:15-12:00 PM||Medical Device Single Audit Program update: Industry perspective||Bryan Brosseau, Brosseau Consulting LLC.
Melinda Smith, Neomed Inc.
|12:00-12:45PM||Medical Device Single Audit Program: FDA Perspective||Rhonda Mecl, FDA – ORA|
|12:45-2:00 PM||Luncheon: " 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 PM||EU MDR status (latest info on implementation)||Philippe Etter, Medidee Services SA|
|2:45-3:30 PM||Recent 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 PM||Deployment of Integrated Risk Management System as Decision Making Tool||Mizanu Kebede, Avanos|
|4:45-5:30 PM||Postmarketing Safety Reporting for Combination Products||Katie Fisher, Vero Biotech|
|6:00-7:30 PM||Networking Reception (RSVP Required)||Hampton Inn|
|Thursday, November 7, 2019 Agenda|
|8:00-8:15 AM||Welcome and Day 2 Overview||Dr. Grace Gowda, Director of UGA Regulatory Sciences|
|8:15-9:00 AM||FDA inspectional approach||Laiza Garcia, FDA-ORA|
|9:00-9:45 AM||Warning Letter Trends||David Van Houten, FDA-ORA|
|9:45-10:30 AM||Notified Body Audits – Challenges and Opportunities||Ralf Gansel, EU|
|10:30-11:00 AM||Morning Break|
|11:00-11:45 AM||Pre-submission and Submission –Do’s and Don’t||Joshua Nipper, FDA-OPEQ|
|11:45-12:30 PM||Regulatory Pathways for Biological Medical Devices||Anna Fallon, Consultant|
|12:30-1:30 PM||Luncheon: "Network Partners – Company Overview and the Regulatory Affairs Apprentice Program"|
• Ratinder Dhami, Director of Regulatory Affairs, Director of Regulatory Affairs
|1:30-2:15 PM||Artificial Intelligence and Machine learning Software on Regulatory Strategy for Medical devices||Scott Thiel, Navigant|
|2:15-3:15 PM||Panel Discussion- "Ask the Regulators"||Moderator: David W. Mullis, Jr.|
|3:15-3:30 PM||Closing Remarks||Dean Kelly Smith, UGA COP|