Sponsored Webcast: Addressing Global Challenges of Inconsistent Classification Systems (on Demand)
This session will tackle the challenge of inconsistent classification systems globally with post-approval variations through side-by-side comparisons of administrative, CTA, and quality changes for 61 countries and hear about an IFPMA (International Federation of Pharmaceutical Manufacturers and Associations) study assessing regulatory frameworks for country-specific postapproval changes compared to the WHO guideline on changes on biotherapeutic products.
By examining key parameters such as change categorization, requirements, and approval timelines, participants will be better equipped to navigate the complexities of global regulatory environments and ensure compliance with evolving standards.
This webcast is designed for regulatory professionals and manufacturers who want to stay ahead in the ever-changing landscape of global chemistry, manufacturing, and controls (CMC) regulations. Attendees will leave with practical knowledge and strategies for managing post-approval variations effectively, positioning themselves to meet new regulatory requirements and drive future advocacy and harmonization initiatives.
Registration Fees & Deadlines
Member: $0|Nonmember: $50
Learning Objectives
- Stay updated with the latest changes and trends in CMC regulations.
- Gain insights into the regional differences and dynamics affecting regulatory processes.
- Understand country-specific postapproval changes guidelines for biotherapeutic products and their convergence level with the WHO guideline on changes on biotherapeutic products
Who Should Attend?
- Director of Regulatory Affairs CMC
- CMC Regulatory Affairs Manager
- CMC Consultant Regulatory Affairs Specialist
- CMC Senior Manager Regulatory Affairs
- CMC VP/Head of Regulatory Intelligence
