How to Navigate the Unpredictable Route to IDMP Compliance: A Tale of 2 Survivors

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How to Navigate the Unpredictable Route to IDMP Compliance: A Tale of 2 Survivors

How to Navigate the Unpredictable Route to IDMP Compliance: A Tale of 2 Survivors

About the speakers
  • Niels Leander
    Niels Leander
    Global Head of Regulatory Affairs at NNIT
    Dr. Niels Buch Leander is a Consulting Director and Global Head of Regulatory Affairs at NNIT, a global IT service provider to the pharmaceutical industry. Dr. Leander has 10 years of R&D IT project experience with eCTD, eTMF, EDMS, RIMS, xEVMPD and ISO IDMP and hence extensive experience with regulatory data standards and their implementation. He advises global pharmaceutical companies on adjusting their business architecture and information architecture to these standards and on how IT strategies are impacted by the standards.
  • Stefan Peev
    Stefan Peev
    Principal Advisory Consultant, Regulatory Affairs at NNIT
    Stefan is a Principal Consultant in Life Sciences Advisory and Consulting at NNIT. He has invested 10 years in Regulatory affairs and his knowledge spans across various parts of the pharma business and its transformation. In addition, IDMP has become his primary focus for the last few years and he is an active member of the EMA Process Focus Group defining the TOM for IDMP. Stefan has come to be a reliable advisor to some of the Top 20 pharmaceutical companies focusing on IDMP, business pains and developing solutions to address them.

Key takeaways