Trade in Transition: AAEI’s 2017 HIC-RIC Seminar

AAEI’s 2017 HIC-RIC Seminar on April 27, 2017, took attendees on a deep dive into the safety, security, regulatory and legislative concerns facing U.S. companies in the healthcare industries and regulated industries. Participants in the all-day event included representatives from the U.S. Food and Drug Administration (FDA), Animal and Plant Health Inspection Service (APHIS) and the U.S. Consumer Product Safety Commission (CPSC), as well as some of the top trade practitioners in the country. This seminar was sponsored by AAEI’s Healthcare Industries Committee (HIC) and Regulated Industries Committee (RIC) and was one of the most highly anticipated events in the trade involving pharmaceuticals, medical devices, food and other regulated products. 

This event was co-hosted by Arent Fox LLP

 

Our Agenda for the Day

Time

Session

Program Segment

Speaker

Location

8:00–8:30 am

 

Registration and Continental Breakfast

 

Multi-Purpose Room Foyer

8:30–8:45 am

General

Welcome and Introductory Remarks

Marianne Rowden, AAEI President & CEO†

 

Multi-Purpose Room

8:45–10:00 am

General

ACE – FDA Response to Import

Donna McDermott, Merck†

Scott Nielsen, Assistant Director of Pharmaceutical Center – Validation and Compliance Branch†

Steve Branch and Jessica Aranda, FDA†

Jessica Sonevytsky, Merck†

Jacquelyn Mohns, Bristol- Myers Squibb†

Multi-Purpose Room

10:00 – 10:15 am

 

Coffee Break

 

MPR Foyer

10:15 – 11:30 am

General

Trump Trade Policy: Known Knowns and Known Unknowns

·   Sanctions

·   Border Adjustment Tax

·   Trade Policy

·   NAFTA Renegotiation

Philip S. English, Arent Fox (former U.S. Congressman)

Kay Georgi, Arent Fox

Dave Hamill, Arent Fox

 

Multi-Purpose Room

11:30 am – 12:30 pm

General

Luncheon

Keynote: Brian Ronholm, Arent Fox

Multi-Purpose Room

12:30 – 1:30 pm

Breakout A

FSMA Foreign Supplier Verification Program- Are you ready for the May 30th compliance date?

  • Challenges with implementation of FSVP controls
  • Best practices for FSVP companies who are suppliers and customers

Erika Faulkenberry, Hershey†

Andrea Bruce, Legal Counsel for Regulatory, Hershey

Maile Gradison, Hermida- Hogan Lovells

Emily Leongini, Arent Fox

John E. Verbeten, Director Division of Import Operations, FDA Office of Regulatory Affairs

Multi-Purpose Room

 

Breakout B

Agency Outreach for APHIS

·  New APHIS ACE Requirements           

Susie Hoeger, Abbott

Cindy Walters, Management and Program Analyst, USDA APHIS

Josue Ledezma, Acting Director of Agriculture Policy and Oversight, CBP

James Swanson, Director, Cargo Security and Controls, CBP

Conference Room

1:30 – 2:30 pm

Breakout C

Global Labeling Requirements

·  Best practices for managing requirements from around the world

 

Multi-Purpose Room

 

Breakout D

OGA Update

·  CPSC

·  FWS

Chris Young, KPMG†

Carol Cave, CPSC◊

Chief Woody, FWS◊

Conference Room

2:30 – 2:45 pm

 

Coffee Break

 

MPR Foyer

2:45 – 3:45 pm

General

Trusted Trader

·   CBP Pilot

o  ISA

·   AAEI Blueprint to Trust Charts

Virginia Thompson, Integration Point†

Erika Faulkeberry†

 

Multi-Purpose Room

3:45 – 4:45 pm

General

What is Happening in the Rest of the World

·  Brexit and EU

·  Asia

·  Latin America

Chris Young, KPMG†

Susie Hoeger Abbott†

 

 

Multi-Purpose Room

4:45 – 5:00 pm

General

Wrap-Up and Closing Remarks

Marianne Rowden, AAEI President & CEO†

 

Multi-Purpose Room

5:00 – 6:00 pm

General

Reception

 

Multi-Purpose Room 

†=confirmed
◊=invited
‡=tentative