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October 16th: Part 2 - Fundamentals of FDA Import Clearance Process, Advanced Chemical Classification and Discussion with Customs on Hand-Carried Shipments
9:30am: Opening Remarks: Luiz da Costa, Associate Director, Global Import-Export & Trade Compliance, Takeda Pharmaceutical International, Ltd., CONECT Vice President
9:35 am - 10:00 am: Hand-Carried Shipments - Message from Customs on Procedures by CBP Agricultural Chief, Elliot Ortiz on how to hand-carry shipments of bio-pharma samples - requirements, risks and proper import clearance.
10:00 am - 11:00 am: CBP: Pharmaceuticals, Health and Chemicals Center of Excellence and Expertise: Update and Enforcement Initiatives Speaker: Marco Afonso, Supervisory Import Specialist, U.S. Customs & Border Protection, Pharmaceuticals, Health & Chemicals Center
Updates on:
- Centers of Excellence and Expertise
- Account Management
Trade Enforcement:
- Overview of Current CBP Trade Enforcement Initiatives
- Free Trade Agreement 101
11:00 am - 11:15 am: Break
11:15 am - 12:45 pm: FDA Import Process Speaker: Troy R. Petrillo, Supervisory Consumer Safety Officer, U.S. Food & Drug Administration, OGROP/ORA/OEIO, Division of Northeast Imports
- Drug Commodity Data Elements Required During the Import Entry Process
- Examine the Current Systems Utilized to Report the Required Data in ACE and Predict
12.45 pm - 1:25 pm: Lunch in Nantucket Room
*1:25 pm - 4:25 pm: Seminar Instructor and Speaker: Andrea Abraham, Customs and International Trade Law, Meeks, Sheppard, Leo & Pillsbury, CONECT Director. Advanced chemical classification training will build on the concepts presented in the full day basic training. It will include discussions involving heterocyclic compounds and complex compounds. Group will work through classification examples.
4:25 pm: Closing Remarks: Luiz da Costa
*(Please note: There will be an afternoon break at an appropriate time during the seminar)
Attendees are encouraged to FORWARD IN ADVANCE and/or BRING examples for hands-on exercises
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