US Laws, Regulations and Industry Best Practices for Excipients

Wednesday, October 20, 2021 - 9:00am
Thursday, November 4, 2021 - 9:00am

This webinar is intended to provide a road map for how the regulatory process in the US works relative to the use of excipients and will focus on requirements for: 

1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. US FDA drug application reviewers

Learning/Awareness Objectives

1. Understanding of responsible regulatory agencies and standards for excipients
2. Excipient information necessary for supporting drug applications
3. Requirements and resources needed for filing and maintain a US Type IV DMF
4. Regulatory considerations for Atypical Actives, colorants/flavors and biological adjuvants.
5. Evolution from bundling review, to registration to joint review of excipients used in drug
6. Emerging hot topics and challenges impacting excipients

Who should attend?

> Excipient manufacturers, users, distributors 
> Regulatory affairs
> Compendial affairs
> Quality affairs

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3449 or email ipecamer@ipecamericas.org