Dr. Xiao Ping Hu

• Manage the submission of Clinical Trial Applications (CTAs) in Clinical trial information system (CTIS) portal as well as all subsequent regulatory activities • Coordinate with functional experts, clinical study teams and external partners, presents project status in relevant committees • Provide case based solutions beyond the regular process and resolve technical and procedural issues through direct interaction with Health Authority stakeholders

• Performing consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions. • Reconciling SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines. • Conducting quality review of endpoint dossiers/adjudication forms. • Querying sites for missing or inconsistent information on endpoint dossiers/adjudication forms.

Project Management, Drug Safety, Regulatory Affairs, Quality management, Labor Management, Clinical Study

Myosin XIX (Myo19) regulates actin-based mitochondrial dynamics. Project clarified the impact of the actin-based motor Myo19 on the dynamics and movement of mitochondria.

Master thesis:Identification and Characterisation of Novel Thermophilic Cellulytic Genes Using Metagenomics. Project characterised novel thermophilic cellulytic genes and enzymes for lignocellulose digestion, which could then be applied to bioethanol production.