Successful Import/Export Programs

precon

8:30 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 10:15 a.m.

Interacting with FDA

  • How to Negotiate with the FDA
    • What to say and what not to say
    • How to set up a telephone call or face-to-face meeting
    • How to prepare for and conduct yourself at a meeting with FDA

10:15 a.m. – 10:30 a.m.

Break

10:30 a.m. – 12:00 p.m.

Managing Import Problems with FDA

  • Mitigating regulatory risk and FDA enforcement damage
    • Shipping strategies and cargo options
    • Foreign supplier options
    • Third party laboratories
    • Insurance
  • Inspection of foreign manufacturers
    • Third party audit
    • FDA inspection
  • Foreign inspection damage control
    • Responding to FDA’s inspectional observations (“Form FDA 483”)
      • When to respond
      • What to say and not say
      • Verification
    • Responding to the FDA’s warning letter and manage automatic detention
      • When to respond
      • What to say and not say
      • Documentation
      • Verification
      • F/U inspection by FDA

12:00 p.m. – 1:00 p.m.

Lunch Break

1:00 p.m. – 2:30 p.m.

FDA Exports

  • Legal authority
    • Adulteration and misbranding exemption
    • Criteria requirements for using the export exemption
      • Basic criteria (Sec. 801(e)(1) of the FD&C Act)
      • New criteria and Tier I countries (Sec. 802 of the FD&C Act)
      • Special criteria for high-risk products that do not meet new export criteria (Sec. 801(e)(2) of the FD&C Act)
  • Export certificates
    • Types and qualifications for use
    • How to obtain an export certificate

Group Break Out Interactive Exercises (Class project)

  • Export Hypothetical I — Selling a Recalled Product Abroad
    • Your firm’s recalled some OTC product in the U.S. because the instructions for use on the label left out storage instructions. You have lots of this product in your warehouse just waiting to be shipped. What are your options?
  • Export Hypothetical II — Shipping a product abroad before approval by a foreign country
    • Your new prescription product is made for your market in France. You expect to receive your CE mark in a few days. What will you do with the product now? Your next market will be Japan and you expect approval in a few months. What can you do now? To your surprise, France does not issue a CE mark and a cargo ship will arrive in France in about 1 week. What will you do now? This shipment was valued for $2,000 when it left Miami, now it is worth a token amount of $1,000. What are your options.

2:30 p.m. – 2:45 p.m.

Break

2:45 p.m. – 4:30 p.m.

FDA Import-for-Export

  • Purpose and legal criteria
  • Foreign Trade Zone status is for U.S. Customs, not the FDA
  • Procedures
    • Notification
    • Accountability
    • What is the “for further processing” criteria mean?

FDA’s Special Import Provisions

  • Trade shows
  • Return for repair
  • Compassionate use
  • Personal baggage

4:30 p.m.

Adjourn Workshop

 

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