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eREGULATORY CHALLENGES
Session Chair(s)
Joerg Schnitzler, PHARMD, MSC, RPH
Head of Global Regulatory Operations
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Learning Objective : 1. Summarize the major regional differences in eCTD filing requirements (eCTD, NeeS, CTD) 2. Achieve understanding of technology solutions available to manage submission filing requirements content 3. Case study of a large multi-national pharma company and their approach to maintaining country-submission filing requirements in a cloud-based web portal
Speaker(s)
Learnings from XEVMPD to Take Forward in IDMP
Jasper Riksen
Astellas Pharma Europe BV, Netherlands
Regulatory Operations Associate
Cloud-based Management of eCTD Global Submission Planners
Mauricha F. Marcussen, MBA
Auditgraph, United States
Founder
RPS and eCTD v.4.0
Joerg Schnitzler, PHARMD, MSC, RPH
Boehringer Ingelheim Pharma GmbH & Co KG, Germany
Head of Global Regulatory Operations
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