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20th - 22nd April 2021
★ 100% virtual conference ★Presented in Central European Time (CET)

Don’t fall at the last hurdle. ECTD V4.0 Global compliance at your fingertips.

Expert strategies on eCTD 4., global differentiations, and key elements of approvals with government agency insights, industry experts and pilot feedback

Cost-Saving Strategies to help you accelerate your path to global submissions success

eCTD Around the Globe

  • Get the latest APAC information on eCTD in China and Japan with those who are involved in pilots with Novartis and Takeshi Adachi, PPG
  • Updates from the MENA region with local experts ALSFA, Jordan
  • eCTD is at various stages globally. Updates from Olga Alfieri, Director, Global Submission Management, Eisai Inc.

The Future of eCTD

  • Get to grips with the latest updates on eCTD 4.0 timelines and status with ICH taskforce member Dr Andreas Franken, BAH   
  • Hear industry's eCTD V4.0 experience in Swiss and EU with Shakul Hameed, Shire 
  • Understand if your vendors are eCTD V4.0 ready with EXTEDO   

Where IDMP and eSubmissions meet

  • Hands on help with the link between IDMP and eCTD in the Interactive Surgery with Joel Finkle, BeiGene, Ltd.
  • Understand the future of documents vs. data with Alistair Nixon, GSK 
  • Interview with IDMP Taskforce members Laurent Desqueper, Merck and Anna Manjavacas, AEMPS  

Your eSubmissions Questions Answered

Connect with pioneers in the pharmaceutical regulatory landscape to help you:

Maintain Compliance with All Submission Types

Streamline Your Submission Processes

Keep Up-to-Date with Global Changes

Ensure Your System Matches with RIM

Successfully Prepare for eCTD v4.0

Discover How AI Can Help with Submission Management