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

· EMA’s Agile Transformation

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

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

· 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

· 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