Pierre-Frédéric Omnes, Executive Director at TransPerfect Life Sciences,  is a regulatory affairs pharmacist with 22 years of experience in regulatory operations oversight of multinational clinical trial applications for New Chemical Entities, Biologics and Advanced therapies (including biosafety regulated products) across several therapeutic areas.  More recently, Pierre supports readiness and execution of EU Clinical Trial Regulation. Pierre is formally part of the EMA-led initiative developing the Clinical Trial Information System Lead Product owner since 2019, continuing an engagement of several years in the testing and optimization of CTIS.