Pierre-Frédéric Omnes recently joined Transperfect Life Sciences & has over 20 years of experience in global CROs and Pharma Companies as Regulatory Affairs consultant, overseeing numerous multinational clinical trial applications globally. He is a subject matter expert on SSU and Regulatory Operations in global clinical trials as well as on the EU CTR 536/2014 for corporate readiness, implementation, EU Portal, transparency. Pierre is part of the EMA-led initiative developing the CTIS as Lead Product Owner representing the Industry & Academia, continuing his engagement of several years in User Acceptance Testings, Workshops and Analysis& Design sessions related to the system development.

Ruediger Pankow holds a university degree in Biology and is a Regulatory Affairs professional with more than 17 years of experience in the clinical research and trials regulatory space, mostly in the CRO industry. His specific area of expertise is the EU Clinical Trials Regulation 536/2014 (EU CTR) and EU CTR implementation at industry level, including for his past employer Parexel. Since 2019 he has been continuously involved for ACRO as an industry stakeholders' representative (sponsor product owner / external SME) in EMA's Clinical Trial Information System (CTIS) delivery project, and is DIA instructor of EMA's CTIS sponsor end user training programme.