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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Dive into the latest regulations

Regulatory Guidances and Legislative Landscape

· Aligning regulatory operations and regulatory affairs teams

· The EU Commission’s Pharmaceutical Strategy for Europe

· The Revision of the EU General Pharmaceuticals Legislation

· Implementing the new Clinical Trials Regulation

Regulatory Information Management and Data Initiatives

· EMA’s Agile Transformation

· Working Group Updates including UNICOM, CTADHL, & ICH MQ4

· Data Initiative Case Studies including DADI, PQ/CMC, CTIS, PLM, & G-SRS

Regulatory Affairs in Global Markets

· Convergence and reliance across all emerging markets

· The current status of ICH adoption globally

· eLabelling initiatives in global markets

· Biosimilar regulations in LATAM, APAC and EMEA

Global eSubmissions

· Current status of eCTD implementation across Europe and industry’s current experiences

· eCTD regional updates including Brazil, China and EAEU

· The intersection of eCTD and IDMP

· Updates from projects including Accumulus Synergy and Orbis