How and When to Use a US Agent When Dealing with the FDA

Date: February 3, 2025
Duration: 60 Minutes
Time: 12 PM EST

The US agent for a company is key connection a company has with the FDA. All companies are required to designate an authorized representative, also called a US agent, for communicating with FDA. The US agent is also the key contact for the US customs for any import and export related issues. For non-US companies, the US agent is generally a contractor or consultant who helps the client navigate US laws and prepare appropriate documentations for regulatory approvals and notifications. It is important to understand the role and responsibilities of the US agent for seamless operations in the US. Lack of US agent could add to the delays and even hold critical decisions from FDA regarding a company.

Why should you attend:
This webinar will discuss the roles and responsibilities of US agents for US-based and non-US companies. The regulatory definition of US agent for different kinds of manufacturers, and locations will be discussed. The presenter will share case studies and examples from his experience acting a US agent for several US and non-US companies with the FDA. Best practices for selection, contracting, and supervision of US agents by client companies will be discussed. Rules for changing a US agent, reporting requirements, and eligibility conditions will be discussed. The seminar is designed as a comprehensive training to manufactures in all aspects of the FDA rules for US agents and practical tips for making the most of your US agent.

Areas Covered in the Session:

FDA definition of a US agent and its scope
Practical considerations for different kinds of products: drugs, cosmetics, devices, cosmetics, supplements, etc
SOPs needed for US agent tasks
Dos and don’ts for US agents
Suggested policies for interactions between US agents and FDA
Best practices for replacing US agents

Who will benefit:

Regulatory affairs personnel
Quality assurance personnel
Vice presidents, Directors and Managers
People interested in investing in the FDA-regulated industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

We accept credit card, debit card, and PayPal.

Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.

In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.