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The Global Roadmap, eCTD 4.0, SPOR.

Refine Your Global eSubmissions Approach For Faster And More Efficient Dossier Approval.

Add to your toolbox for successful global dossier submissions

The future of eCTD...
  • eCTD v4.0: Timelines, scope and industry feedback with Bayer
  • Will eCTD benefit industry and patients? Hear both sides of the argument with GSK and Roche
  • Looking for insight into opportunities for alignment and harmonisation amongst Health Authorities to improve submissions globally? Hear our expert panel discuss the global implementation of CTDs

eSubmissions around the globe...
  • To what extent is Brazil prepared for eCTD? Obtain direct feedback from ANVISA 
  • Gain insight from an EFPIA company, GSK, on how the industry can influence GCC countries to further harmonise with other regions and standardisation 
  • Get your questions answered by experts from China, Turkey, Russia and more... 

Join our RIM audience for...
  • Clarity on the definition and scope of the HL7 FHIR standard: Hear from Vada A. Perkins, Bayer, as he discusses how industry and regulatory domain might use FHIR
  • Information on assessing the status of the Clinical Trial Portal
  • Practical Guidance on transforming from a document-driven to the regulatory organisation into a data-driven organisation

Conference Workshop: Filing Variations

Join our full day Filing Variations workshop on 23rd of April, with Sumaiya Patel, a director of a regulatory consultancy with over 11 years’ experience in both pre and post approvals for generic, CRO and big pharma organisations.

Run by Pharmaceutical Training International, our official training partner, this workshop will provide you with the knowledge necessary to ensure speedy regulatory approval and filing variation procedures that are cost-effective.