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 holds a university degree in Biology and is a clinical regulatory affairs professional with history of more than 16 years in the CRO industry at Parexel, where he last was Principal Consultant in the clinical trial regulatory services. He was involved in his company's EU Clinical Trials Regulation 536/2014 (EU CTR) readiness implementation, and has contributed for ACRO to EU CTR stakeholder activities with EU Regulators and EMA. Since 2019 he has been a sponsor product owner for ACRO in EMA's Clinical Trials Information System (CTIS) delivery project providing input on design and development of system functionalities and guidance material, and is DIA instructor of EMA's CTIS sponsor user training programme.