APIs in the dossier: Quality data, e-submission, global regulatory strategy - Includes updates on (Draft) ICH Q1, ICH M4Q(R2)), ICH Q12, Reliance, AI,

- Overview and scope of ICH guidelines - Manufacturing processes, impurities, specifications and stability - Structure of CTD module 3.2.S, changes according to ICH M4Q(R2) - ASMF and CEP procedures - e-submission requirements to active ingredients - Global approval relevant API changes: Challenges & opportunitiesAre you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the right seminar for you! Includes updates on (Draft) ICH Q1, (Draft) ICH M4Q(R2), and ASMF topics, as well as information on new regulatory trends such as ICH Q12, reliance, and AI.LernzieleThe regulatory environment for active pharmaceutical ingredients (APIs) is changing rapidly.Keeping pace requires more than just knowing the guidelines.- This seminar provides comprehensive, practice-oriented training on current and upcoming CMC documentation standards, including the revised CTD structure under ICH M4Q(R2), impurity control requirements, ASMF, CEP, as well as practical guidance on eCTD submissions and global post-approval change management. Real-world cases and expert insights support the understanding of the specific daily challenges to be mastered.Attendees will leave with a solid understanding of EU/ICH requirements, global regulatory strategies, and emerging trends.ZielgruppenThis seminar is designed for specialists and managers in Regulatory Affairs, CMC, R&D, and GMP-Quality who are responsible for integrating API quality data into marketing authorisation dossiers or managing API-related submissions and lifecycle activities.- The focus is on small molecules and current EU regulatory requirements.