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Global Pharmaceutical Regulatory Affairs Summit
22-24 October 2024
Sheraton Brussels Airport, BrusselsHybrid Event

Darius-Jean Namdjou
Head of Regulatory Affairs & Pharmacovigilance at Immunic Therapeutics
Speaker

Profile

Dr. Darius-Jean Namdjou graduated as Ph.D. chemist from Aachen University, Germany, in 2006. After a two year Post-Doc stay at the National Research Council in Ottawa, Canada and further professional training, Darius joined the headquarter of Grünenthal GmbH, Aachen, Germany as Regulatory Affairs Manager in 2009. Darius gathered two years experience with the coordination of marketing authorization and lifecycle activities in emerging and further RoW markets, covering the product portfolio of Grünenthal. Since August 2011, Darius lead Regulatory Affairs product teams, on a global level, for several of Grünenthal’s development and established pain products. He further specialized himself on the Regulatory Affairs part of Due Diligence projects.

Since March 2021, Darius took on a new challenge by joining the clinical stage biotech company Immunic AG in Munich, Germany, specialized in autoimmune and inflammatory diseases. Darius leads the Regulatory Affairs and Pharmacovigilance team for the company. In this role, he is currently further building up the team and respective internal functional structures to support the global development of the company’s compounds - with focus on US FDA - while also managing and further strengthening the relationship to vendors specialized in the Regulatory Affairs and Pharmacovigilance field.

Darius is a member of the Drug Information Association (DIA), German Society for Regulatory Affairs (DGRA) and the Regulatory Affairs group of BioGermany. Darius is a regular speaker at conferences and a lecturer in Regulatory Affairs for the University of Duisburg-Essen (UDE).

Agenda Sessions

  • Chair’s opening remarks

    09:00
  • A Strategic Example: Implementation of the Clinical Trials Regulation

    11:10
  • Chair’s afternoon remarks

    14:10
  • Big Picture Panel: The Future of Legislation, Regulatory Affairs & Regulatory Operations

    16:45