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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: What lies ahead?
  • eCTD v4.0: Timelines, scope and industry feedback with Bayer
  • Will eCTD 4.0 benefit industry and patients? Hear both sides of the debate with GSK and Roche
  • Hear how Health Authorities are working towards global alignment for eCTD submissions from an expert panel
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... 

eSubmissions in the bigger regulatory picture
  • With the latest updates, guidelines and feedback on HL7 FHIR with Bayer
  • Hear the future of the Clinical Trial Portal and how UDI + EUDAMED affect the pharma industry with Grünenthal GmbH
  • Join the discussion on how industry can make the shift from a siloed to an integrated way of thinking and working with leading Industry Panel
  • Hear the latest updated on CESSP: Where are we with migrating the Electronic Application form into the CESSP?

eSubmissions: What's On?

HEALTH AUTHORITY AND INDUSTRY PANEL DISCUSSION | Global eSubmissions regulatory landscape: Preparing for the future
  • Assessing the strategic roadmaps for electronic submissions
  • Assessing opportunities for alignment and harmonisation amongst Health Authorities to improve submissions globally
  • Examining common pitfalls during eSubmissions processes and how they can be avoided
  • Advice for industry when planning a global eSubmissions strategy

Alastair Nixon, Director, Submission Standards, Global Regulatory Platform & Delivery, GlaxoSmithKline Research & Development Ltd

Massimiliano Sarra, Preclinical & Clinical Assessor, AIFA Agenzia Italiana del Farmaco

Tim Powell, Associate Director, Global Regulatory Operations, Biogen

eCTD v4.0: Timelines, scope and industry feedback
  • Assessing the status of eCTD v4.0
  • Examining the time-lines for implementation
  • Assessing feedback from ICH and industry

Bernd Misselwitz, Director, Regional Head of Regulatory Submission, Bayer

eCTD preparedness in Brazil: Where are we now?
  • Understanding where ANVISA is in their journey towards being eCTD ready
  • Assessing what direction ANVISA is taking
  • Gaining insight into the wider discussion happening in LATAM

Patrícia Kott Tomazett, Health Regulatory Specialist, General Management of Drugs, Brazilian Health Surveillance Agency (ANVISA) 

An update on eSubmissions in China
  • Providing clarification on the move to the eCTD
  • Assessing available guidance for eSubmissions in China
  • Practical advice for submitting to China
  • Examining the common pitfalls and understanding how to overcome them

Dai Wan, Regulatory Project Manager, Merck 

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.