Extractables & Leachables: Current CMC requirements in light of the upcoming ICH Q3E - CMC compliance: What to do now and what ICH Q3E will bring

- Regulatory expectations and CMC requirements (as currently in place to ICH Q3E) - Industry strategies for current global E&L requirements - ICH Q3E under development: Scope and key principles from an authority perspective - From draft to operations: How industry can prepare for ICH Q3EE&L and CMC compliance: After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.LernzieleThis seminar provides you with a comprehensive overview of the draft regulatory framework of the ICH Q3E, specific CMC requirements, and practical implementation strategies based on both authority and industry perspectives.The seminar covers the regulatory framework and CMC-specific requirements outlined in the draft guideline, including study design, safety assessments, and Module 3 documentation.Beyond that, the seminar will also explore how ICH Q3E integrates with the existing E&L guidance documents, such as the USP E&L chapters and BPOG, providing a clear understanding of how these standards work together to support a robust global regulatory strategy.- After having participated in the seminar you will be equipped to navigate the upcoming requirements confidently and proactively prepare your organisation for the implementation of ICH Q3E.ZielgruppenThis seminar is designed for experienced professionals in Regulatory Affairs and CMC who are responsible for regulatory submissions, dossier preparation, and quality documentation.Professionals that need to navigate todays E&L regulatory landscape while anticipating tomorrows guideline(s) will particularly benefit from participating.