Darius-Jean Namdjou

Director, Senior Regulatory Lead at Phortas GmbH

Speaker

Darius offers 15+ years of industry experience, in both, Pharma and Biotech, in Regulatory Affairs plus 3 years in Pharmacovigilance. 10 years experience in Regulatory Affairs leadership positions including building up a team and installing processes from scratch as well as being direct report to company management.

Since 2024, Darius has changed career paths to Regulatory Affairs/Development consulting. In this role, he is dealing with various global projects, mainly in cooperation with SMEs, in all stages of development of medicinal products, with the geographical scope including US, EU and Emerging Markets, covering various indications. Core expertise includes Due Diligence, Authority meetings (EU Scientific Advice, FDA Type meetings), coordination of complex submissions (e.g. INDs, PIPs/PSPs), Regulatory Intelligence & impact assessments, Regulatory Strategy input to cross-functional teams, and also hands-on submission work in the clinical trial and post-marketing setting.

In Pharmacovigilance, Darius has been overseeing process development for Clinical Safety in a Biotech, validated via a regulatory inspection.

Darius has extensive experience in vendor management. He is a regular speaker at conferences, member of several industry associations and initiatives, currently being mainly focused on the EFPIA/EFGCP EU-X-CT initiative.