Overview of Excipient Laws and Regulations in Europe

Tuesday, November 16, 2021 - 9:00am

This webinar is intended to provide a road map for how the regulatory process in Europe works relative to the use of excipients with a focus on requirements for:
1. Excipient manufacturers/suppliers
2. Drug manufacturer/excipient users
3. European regulatory bodies and competent authorities

Learning/Awareness Objectives
Attendees will be provided with:
> Understanding of responsible European regulatory agencies and standards for excipients
> Understanding of local law/regulations for registration and/or import of excipients
> Excipient monograph regulatory and testing requirements
> Excipient information necessary for supporting drug applications
> General overview of Certificate of Suitability (CEP) process and when/how used
> Regulatory considerations for Atypical Actives and colorants
> 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