AFDO Drug & Medical Products Conference

Conference Dates

Dates: April 13-14, 2021
Location: Virtual Conference
Time: 1:00pm – 4:00pm ET Each Day

Free Registration

About the Conference

2021 continues to be a year of change and innovation on the heels of a year that required it.  This year, AFDO and the U.S. Food and Drug Administration will co-sponsor the Drug and Medical Products Virtual Educational Conference as it returns to the learning and networking event calendar. The conference will be the premier place to get updates from key regulatory leaders from the U.S., Canada, and industry in the Drug and Medical Products arena in this time of change.

The information-packed virtual event will take place in two three-hour sessions you can join at your computer on April 13 and 14 from 1:00 to 4 p.m. EDT each day. All you need to invest is your time to get the full benefit of this opportunity because the event is free. Registration is required.

AFDO members and stakeholders play a critical role in formulating law, regulations and best practices related to drugs and medical products. The annual conference is just one of the ways you can be involved. To learn more about the AFDO Drug and Medical Products Committee work or to join click here

Co-sponsorship of this event by the FDA does not imply an endorsement of the general policies, activities, or products of AFDO or any of the event’s additional sponsors.

Sponsors

Additional support for the event comes from Ceutical Labs and BioTeknia.

Agenda

Tuesday, April 13, 2021

1:00 – 1:10pm ET  Welcome and Survey of Participants

  • Steven Mandernach, Executive Director, Association of Food and Drug Officials

Session Moderator: Scott McIntire, Division Director, Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, 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, Office of Regulatory Affairs, 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
  • 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 ETManaging 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, 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

1:00 – 1:10pm ET   –   Welcome and Survey of Participants  

  • Steven Mandernach, Executive Director, Association of Food and Drug Officials

Session Moderator:  Nancy Singer, President, Compliance-Alliance, LLC

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

  • Francisco Vincenty, Program Manager for the Case for Quality, Office of Compliance, Division of Clinical Evaluation and Analysis, U.S. Department of Food and Drugs Administration

 2:50 – 3:50pm ET – Compliance/Interactive Session Get Your Questions Answered

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, 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

Speaker Information

John Cancato

John Concato is the Associate Director for Real-Word Evidence Analytics in the Office of Medical Policy (OMP) at the Center for Drug Evaluation and Research (CDER), US Food and Drug Administration. In seeking to enhance policies related to drug development and regulatory review, his responsibilities involve coordinating CDER’s real-world evidence (RWE) Program, serving as Chair of the RWE Subcommittee, supporting RWE guidance development and demonstration projects, interacting with external stakeholders regarding RWE, and developing internal Agency processes related to RWE. He also supports other activities and initiatives in the Office of Medical Policy Initiatives (OMPI). Prior to joining FDA in 2019, his career focused on generating research as an independent investigator and research center director at Yale University School of Medicine and the U.S. Department of Veterans Affairs (VA), including serving as one of two founding principal investigators of the VA Million Veteran Program. He received M.D. and M.S. degrees from New York University and an M.P.H. degree from Yale University.

Dawne Hines

Dawne Hines became the Division Director of the Division of Northeast Imports on February 18, 2018.  She is responsible for the investigations and compliance staff who ensure that the FDA regulated products entering the country through the airports, seaports, and International Mail Facilities from Maine to Virginia are in compliance with FDA regulations.

Ms. Hines became the Director of Investigations Branch for the Division of Northeast Imports in May 2017 following the standup of FDA’s Program Alignment initiative: FDA Program Alignment  

From March 2017 until the standup of Program Alignment, Ms. Hines was the Director of Import Operations Branch (Downstate) of New York District, responsible for the oversight of the investigational staff at the New York and New Jersey airports and seaports.

From May 2012 until March 2017, Ms. Hines was the Director of Investigations Branch for the Atlanta District located in College Park, GA responsible for the oversight of all inspectional activities throughout the states of North Carolina, South Carolina, and Georgia, including both domestic and import operations.  There she established and strengthened relationships with various Partner Government Agencies, Port Authorities, and State counterparts to improve communication and collaboration.

In 2008, Ms. Hines was a Supervisory Investigator in Miami and then in Port Everglades in 2009 with the Florida District.  There she supervised the Miami International Mail Facility, the opening of the Port Everglades Resident Post, and the construction of the Port Everglades Screening Station.  She led a team of ten investigators, and she worked closely with CBP at Port Everglades to develop a joint tailgate and CES inspection procedure to maximize limited government inspectional resources.   

Ms. Hines began her FDA career in 2002 in Miami as an Investigator.  She gained knowledge and skills in the following areas: import field examinations; sample collections; filer evaluations; seafood and juice HACCP; international mail examinations; and entry review of processed foods, drugs, medical devices, cosmetics, and biologics.


Ms. Hines holds a BS in Biology and a BA in Spanish from Dickinson College in Carlisle, PA.  She also obtained a Lean Six Sigma Green Belt from Villanova University.  Prior to joining FDA, Ms. Hines was a high school Spanish teacher.

Kim Trautman

EXPERIENCE

Kimberly A. Trautman is an experienced Medical Devices and InVitro Diagnostics Executive Vice President with over 30 years of experience. She worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe. Industry experience as well as regulatory agency experience. Demonstrated history of working collaboratively with industry, regulators and patient groups for the betterment of public health. Executes several medical device regulatory services and developed a formal Education/Training business. Established an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body for EU IVDR/MDR Designation.

Expert in global medical device regulations, wrote and harmonized the current US FDA Quality System Regulation and was on the international authoring group of ISO 13485 since inception. Conceived and developed the Medical Device Single Audit Program and its consortium of five Global Regulators. Twenty-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Recognized International Medical Device expert with a Master’s Degree in Biomedical Engineering.

EDUCATION

M.S. of Biomedical & Medical Engineering, University of Virginia, Charlottesville, VA

B.Sc. of Molecular Cell Biology and Engineering Sciences, Pennsylvania State University, State College, PA

Scott MacIntire

Scott J. MacIntire, Director, Division of Enforcement, Office of Strategic Planning and Operational Policy, Office of Regulatory Affairs, FDA

Since November of 2014, Scott MacIntire has been the Director of the Division of Enforcement at FDA’s Office of Regulatory Affairs (ORA).  Scott works closely with the ORA field divisions and FDA centers in determining voluntary and regulatory strategies for follow up action.  He also serves as the Agency focal point for guidance on recall plans and procedures, directs and coordinates ORA’s activities related to the investigation of health fraud, and provides management and oversight of the Agency’s debarment program.  He is currently an advisor to the Strategic Coordinated Oversight of Recall Execution (SCORE) team which was formed as an Agency response to the OIG Food Recall Study.  Prior to his current position, Scott was Director of the Chicago District Office from 2004 to 2014.

Scott has a bachelor of science degree from East Tennessee State University and has worked in the field of public health protection for the past 38 years, 31 of those years with the FDA. 

Elizabeth Miller

Column 3

Dr. Elizabeth Miller recently rejoined the US FDA in March 2020.  In her role as the Assistant Commissioner for Medical Products and Tobacco Operations, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.

Dr. Miller comes returns from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA.  At USP, Dr. Miller was vice president, US Public Policy & Regulatory Affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.

Before rejoining USP in 2016, Dr. Miller began her federal career with FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC).  She began her CDER career working on online pharmacy and health fraud issues, and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.

Prior to federal service, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication.  She started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C.

Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and received her Doctor of Pharmacy degree from the University of Maryland.

Pablo Morales

Pablo Morales, MD, is the Chief Medical Officer in the Office of Clinical Evidence and Analysis in the Center for Devices and Radiological Health (CDRH) at FDA. Dr. Morales received his MD from Universidad Pontificia Bolivariana, Colombia, South America. He trained in vascular and endovascular surgery at Guy’s and St Thomas’ Hospital in London, UK, where he also completed a research fellowship in interventional radiology.  He joined the FDA as a medical officer in 2008, after working in endovascular research at the Cleveland Clinic for two years. He serves as the clinical authority in providing support to FDA device specific offices in reviewing and evaluating clinical and research findings, real-world clinical evidence, analyses, laboratory and clinical behavior, and the impact of these factors and properties on the safety and effectiveness of medical devices.

Emily Thakur

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