Speakers
This in-depth session addresses the challenge of inconsistent classification systems globally with post-approval variations, featuring side-by-side comparisons of administrative, CTA, and quality changes across countries, alongside a review of an IFPMA study assessing regulatory frameworks for country-specific Post-Approval Changes (PACs) compared to the WHO Guideline on biotherapeutic products.
Key topics include:
- CMC regulatory trends: Stay updated with the latest changes and trends in CMC regulations.
- Regional dynamics: Gain insights into the regional differences and dynamics affecting regulatory processes.
- Country-specific PACs guidelines: Understand the convergence level of country-specific PACs guidelines with the WHO guideline on biotherapeutic products.
Why attend?
Designed for regulatory professionals and manufacturers, this webinar equips you with practical knowledge and strategies to manage post-approval variations effectively. You’ll be better prepared to navigate the complexities of global regulatory environments, ensure compliance with evolving standards, and drive future advocacy and harmonization initiatives.
Key takeaways:
- Examine key parameters such as change categorization, requirements, and approval timelines.
- Gain practical strategies to manage post-approval variations.
- Position yourself to meet new regulatory requirements and drive future advocacy.
