Wednesday, August 17, 2022, 8:00am - 10:00am EDT
This
webinar focused on current and emerging NMPA regulatory activities
in China related to the use and approval of excipients, including but
not limited to:
1. Evolution of excipient regulations in China
2.
The regulatory management requirements and the coping strategies of
cooperation between excipient producers and users for global companies
3. Regulatory compliance challenges and key advice on China excipients filing, CHP compliance and bundling evaluation with drugs
4. Open discussion and 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 excipients managements 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