New FDA Oversight: How to Negotiate An Import Hold Crisis

Online, September 6, 2013 (Newswire.com) - 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 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 and
• Six ways to best communicate with FDA staff to keep your shipment moving towards its delivery goal

Register today at www.fdanews.com/ImportHoldsVCPR3

In just one fast-paced day, you'll hear from:

• Casper Uldriks, Counsel, Olsson Frank Weeda Law; former Associate Director for Regulatory Guidance and Government Affairs, CDRH (invited). Casper spent 30 years at the FDA and is one of the nation's top experts on import holds and supplier management issues.

• 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, 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 conference couldn't be timelier.

FDA Import Holds: New Powers to Control Products is convenient to attend. All that's required is that your team be in front of a screen at the appointed time. Register today at www.fdanews.com/ImportHoldsVCPR3

Who Will Benefit
Drug, device, biologics or diagnostics, every FDA-regulated company that deals with offshore importers is a candidate for participation. It's ideal for:

• Compliance officers
• Executive management
• Supply chain managers
• Warehouse/shipping managers/supervisors
• Consultants/service providers involved in imports
• General/corporate counsel
• Manufacturing directors and supervisors to the extent manufacturing aspects involve imported material
• Regulatory/legislative affairs professionals

Conference Details
FDA Import Holds
New Powers to Control Products
**FDAnews Virtual Conference**
Sept. 24, 2013 - 10:00 a.m. - 4:00 p.m. EDT
www.fdanews.com/ImportHoldsVCPR3

Tuition
$1,297 per site -- includes virtual conference registration and audio cds and transcripts

Easy Ways to Register
Online: www.fdanews.com/ImportHoldsVCPR3
By phone: 888-838-5578 or 703-538-7600