Regulatory Revolutions and eCTD 4.0
eCTD 4.0 is coming with imminent implementation in some countries. This webinar will present an overview of current ICH Adoption status around the world while presenting alternative implementation strategies as we evolve into eCTD 4.0 amidst data revolutions, expedited ways of submitting dynamic dossiers, and integrating document / information activities. We will present the status of ICH eCTD 4.0 dates across the globe, including a case study for best practices in Brazil. We will also present real experience with FHIR in the Clinical arena and identify some challenges incorporating CMC in FHIR. Finally, eCTD version 4.0 presents an opportunity to get ready for data revolutions including SPOR and IDMP.