FDA Import HoldsNew Powers to Control Products
Product Details
The FDA has a new weapon in its arsenal – the ability to detain for up to 20 days drug products it believes are adulterated or misbranded, in addition to its existing import hold powers. And, it’s working closer than ever with Customs and Border Protection and the USDA to stop bad shipments.
Customs officials don’t care that your shipment may be perishable and deteriorating by the minute. If the supplier has been tagged in the PREDICT system the product has been identified as adulterated, your shipment can be stopped cold.
To bring you up to date on these new powers, the status of the PREDICT system, the new PLAIR guidance and the proposed Qualified Trusted Importer Program, FDAnews has brought together a top-notch team to teach you the following:
- Best practices for getting pre-admission decision before your product reaches the border
- What the most common problems are with labeling
- Details on the Qualified Trusted Import program
- How the PREDICT system has been working post-rollout
- Six ways to best communicate with FDA staff to keep your shipment moving towards its delivery goal
In just one fast-paced day, you’ll hear from…
- Benjamin England, Founder and CEO, Benjamin L. England & Associates, LLC & FDAImports.com LLC. Ben is a 17 year veteran of the FDA. Among other things, he worked as program manager for PREDICT and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs.
- Michael Mullen, Executive Director, Express Association of America. Mike frequently meets with FDA officials to help improve importation issues. Most recently, he met with Melinda Plaiser, Acting Associate Commissioner, regarding recommendations on FDA import entry admissibility decisions.
- William Nychis, Senior Regulatory Advisor, FDAimports.com. William has nearly 40 years of experience at FDA. He drafted numerous guidance documents, import alerts and policy documents for FDA.
- Jim Johnson, Pharmaceutical and Life Sciences Group, Hogan Lovells; formerly Associate Chief Counsel, Office of the Chief Counsel, FDA. Jim has been on both sides of import holds – enforcing them on behalf of the FDA and successfully getting clients’ products released from them.
This virtual conference CD and transcript set, sponsored by FDAnews, features top experts who have been in the import holds trenches. Without ever leaving the comfort of your office, you’ll gain practical knowledge that helps you assure your valuable product makes it from supplier to your loading dock without problems.
For drug, device, biologics and diagnostics companies that deal with overseas suppliers, this CD and transcript set couldn’t be timelier.
Agenda
10:00 a.m. – 10:15 a.m. |
Introduction to the Virtual Conference |
10:15 a.m. – 11:15 a.m. |
The New Enforcement Posture: PREDICT, PLAIR, Customs and 2013 FDA Trends Attendees will learn:
Benjamin England, Founder & CEO, Benjamin L. England & Associates LLC and FDAImports.com |
11:15 a.m. – 11:30 a.m. |
Break |
11:30 a.m. – 12:30 p.m. |
Certified Importer Approach: Better than Transactional Controls —Assessing the Potential for Integrated Border Management Between the FDA, Customs and USDA Attendees will learn:
Michael Mullen, Executive Director, Express Association of America |
12:30 p.m. – 1:30 p.m. |
Lunch |
1:30 p.m. – 2:30 p.m. |
FDA Imports: Surviving an FDA Import Hold Crisis Attendees will learn:
William Nychis, Senior Regulatory Advisor, Benjamin L. England & Associates |
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
How to Review Product Labeling to Avoid FDA Import Compliance Woes — 5 Steps You Need to Take Attendees will learn:
Jim Johnson, Pharmaceutical and Life Sciences Group, Hogan Lovells |
3:45 p.m. – 4:00 p.m. |
Closing Comments and Adjournment |