Director, Senior Regulatory Lead
Phortas GmbH
Aachen, Nordrhein-Westfalen, Germany
Darius, a Regulatory consultant, currently Director, Senior Regulatory Lead at Phortas Gmbh, Germany, has 15+ years of experience in driving forward, performing strategic work and hands-on execution of the regulatory part of projects in Biotech and Pharmaceutical Drug Regulatory Affairs, for both, development and marketed products. Darius has gained extensive experience in leading small to mid-sized Regulatory teams, building up of such teams and relevant processes/SOPs from scratch, including processes to comply with the new European Clinical Trial Regulation (EU CTR). Darius is successfully managing projects on a global scale, including interactions with US FDA, EMA, national EU regulators, Latin American regulators such as ANVISA, supra-national body WHO, hereby developing Regulatory strategies and handling key submissions to enable business growth and sustainability, encompassing diverse cultural environments. Darius has a proven track record of successful meetings with regulatory authorities and in obtaining clinical trial application , marketing authorization and post-marketing submission approvals. Darius' projects, relate to both, small molecule drugs and biologicals, and have covered a wide array of indications, including autoimmune diseases, neurological, gastrointestinal conditions, oncology, infectious diseases and pain.
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Current Developments and Regulatory Trends in Clinical Trial Design
Thursday, May 15, 2025
12:00 - 13:00 CEST