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Agenda
Tuesday, April 13, 2021
1:00 – 1:10pm ET Welcome and Survey of Participants
- Steve Mandernach, Executive Director, Association of Food and Drug Officials
Session Moderator: Scott McIntire, Division Director, Division of Enforcement, U.S. Food and Drug Administration
1:10 – 1:40pm ET FDA – Where We Are and Where We May Be Going in the Area of Drug Quality in 2021 and Beyond
- Alonza Cruse, Director, Office of Pharmaceutical Quality Operations, U.S. Food and Drug Administration
1:40 – 2:10pm ET – The Opportunities and Challenges of Using Real World Evidence to Support FDA’s Regulatory Decisions in the Area of Drug, Biologics and Devices
- John Concato, Associate Director for Real-World Evidence Analytics, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- Jose (Pablo) Morales, MD, Chief Medical Officer, Office of Clinical Evidence and Analysis, Center for Devices and Radiological Health, U.S. Food and Drug Administration
2:10 – 2:20 – Break
Session Moderator: Cynthia Culmo, Principal Consultant, CC Consulting
2:20 – 2:50pm ET – Managing and Preventing Drug and Device Shortages
- Emily Thakur, R.Ph., Team Leader Drug Shortages Staff, U.S. Food and Drug Administration
2:50 – 3:20pm ET – Managing and Selling Medical Devices in the UK and Northern Ireland
- Kimberly Trautman, Executive Vice President, Medical Device International Services, NSF Medical Devices
3:20 – 3:50pm ET – Update on Canadian Regulation of Drugs and Medical Products
- Mary Morgan, a/Director, Health Product Compliance Risk Management, Regulatory Operation Enforcement Branch, Health Canada Ottawa
- Chad Sheehy, Acting Director, Medical Devices Compliance Program, Regulatory Operations and Enforcement Branch, Health Canada
3:50 to 4:00pm ET – Closing Remark
- Megan Snyder, Manager, Drugs and Medical Devices, Texas Department of State Health Services, AFDO Co- Chair of Drugs, Devices & Cosmetics Committee
Wednesday, April 14, 2021
Session Moderator: Nancy Singer, President, Compliance-Alliance, LLC
1:00 – 1:10pm ET – Welcome and Survey of Participants
1:10 – 1:40pm ET – FDA Inspections and Enforcement Actions in This New Environment
- Elizabeth Miller, Pharma.D., Assistant Commissioner for Medical Products And Tobacco Operations, Office of Regulatory Affairs, U.S. Food and Drug Administration
1:40 – 2:10pm ET – Update on Products Coming into the United States
- Dan Solis, Assistant Commissioner for Import Operations, U.S. Food and Drug Administration
2:10 – 2:20pm ET – Break
Session Moderator: Ballard Graham, Retired, U.S. Department of Food and Drug Administration
2:20 – 2:50pm ET – CDRH Quality Pilot – Voluntary Medical Device Manufacturing and Product Quality
2:50 – 3:50pm ET – Compliance/Interactive Session
Moderator – Julie Larson, Principal, Director of Inspection Readiness, BioTeknica
- Scott MacIntire, Director, Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, U.S. Food and Drug Administration
- Mary Morgan, a/Director, Health Product Compliance Risk Management, Regulatory Operation Enforcement Branch, Health Canada Ottawa
- Dawne Hines, Division Director, Division of Northeast Imports, Office of Regulatory Affairs, U.S. Food and Drug Administration
3:50 – 4:00 – Closing Remarks
- Mark Sestak, AFDO President, Deputy Director, Division of Food, Milk, & Lodging, Alabama Department of Public Health Alabama Department of Public Health
