Webinar - US Laws, Regulations and Industry Best Practices for Excipients

Category: Other
  • IPEC-Americas - 3138 10th Street N. Suite 500 - Arlington, VA 22201 - United States
  • 20 Oct - 4 Nov 2021

Dates:  Part 2 - Thursday, November 4, 2021 - 14:00-16:00 CET
Part 1 - recorded on Wednesday, October 20, 2021 available on demand

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

Presenters

Kimberly Parker Howard
Senior Regulatory Specialist, NuSil Technology LLC

Priscilla Zawislak
Global Regulatory Affairs Advocacy Manager IFF (International Flavors & Fragrances), Vice President, IPEC Federation and Immediate Past-Chair, IPEC-Americas

 

Registration Fees

IPEC-Americas Members and IPEC Europe Members - $179
General Registration - $359

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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