ExpertFORUM Global Regulatory Affairs - Trends and Strategies

- Joint Scientific Consultation and global evidence planning - Reliance pathways: ACCESS, ORBIS, OPEN - Strategic real-world evidence generation - Global implementation of ISO IDMP and eCTD 4.0 - Strategies for global lifecycle management - AI in regulatory intelligenceThis online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical takeaways and lively discussions with experienced speakers - and stay informed about the latest developments in global regulatory practices.LernzieleGlobal regulatory alignment is advancing rapidly. Joint review procedures, harmonised evidence requirements and evolving digital standards are reshaping the way pharmaceutical companies plan submissions and navigate international market access. For regulatory professionals, staying current with these developments is not a peripheral task, it is a strategic necessity.- This conference provides a consolidated, practice-oriented overview of the regulatory trends that matter most, including the convergence of regulatory and HTA requirements and the growing relevance of AI in supporting global regulatory strategies. Seven focused expert presentations deliver substantive insight across key areas of international regulatory alignment, structured to be directly applicable to strategic work and day-to-day decision-making.- Participants will leave with a sharper understanding of where global regulatory convergence stands today, where it is heading and how to position their organisation to respond effectively.ZielgruppenThis conference is designed for regulatory affairs managers and professionals operating in international contexts, particularly those with responsibility for strategic regulatory planning, global submissions and international market access for pharmaceuticals. A solid working knowledge of international regulatory frameworks and standard submission procedures is recommended.