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Webinar - Overview of Excipient Laws and Regulations in Europe

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

Date and time: Tuesday, November 16, 2021 - 9:00-11:00 EST / 15:00-17:00 CET

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

Presenters

Dr. Johanna Eisele, Global Head of Regulatory Affairs, Business Line Health Care, Evonik Operations GmbH

Ms. Yasemin Koybasi, Global Regulatory and Scientific Affairs, Senior Manager, Kerry Applied Health and Nutrition

Registration Fees
IPEC Europe and IPEC-Americas Members: 89$
Non Members: 179$

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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