Excipient and Drug Regulations in China; Interpretation and Management Strategies

Wednesday, August 17, 2022 - 8:00am

This webinar will focus on current and emerging NMPA regulatory activities in China related to the use and approval of excipients:
1. Evolution of excipient regulations in China
2. Regulatory management requirements and communications strategies for excipient producers and users
3. Regulatory compliance challenges, CHP compliance, and bundling evaluation
4. Open discussion, interaction and Q&A

Learning/Awareness Objectives
1. Understanding the evolution of bundling review from registration to joint review of excipients used in drug products
2. Overview of the China pharmaceutical regulatory bodies and major responsibility for excipient management for bundled review and approval with drugs
3. Concerns with current excipient registration document requirements in China and suggestions for a registration strategy and change management
4. Review of current and future ChP development

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