Niels Leander

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.