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This track explores how submission practices and policies are evolving, both within Europe and globally. Key topics include the telematics strategy (EMA and beyond), digital tools, SPOR implementations and effective outsourcing. This track is ideal for professionals leading and working in regulatory operations and for those on the agency side assessing and approving dossiers.
Who is This Track Designed For?
Professionals involved in regulatory operations, regulatory submissions, eCTD, document management and regulatory solution providers.