Celso Vespasiano

Clinical trial design, conduct and scientific medical writing team leadership.

Teaching Assistant I at Principles and Practice of Clinical Research Teaching Assistant I, a program offered by Harvard T.H. Chan School of Public Health and directed by Prof. Felipe Fregni.

Team leadership for clinical trial design and scientific medical writing.

Responsible for Startup activities (Initial contact, feasibility questionnaire, Site Selection, Study initiation, Site initiation, elaboration of regulatory package and other documents, training and related activities) of Global Phase IV Studies with Oncology and Antibiotics drugs.

Monitoring of Clinical Trials and Bioequivalence comprising activities: Preparation of reports, ensuring compliance with GCP , GLP and existing regulations; Study initiation and close out, ensure compliance with the clinical protocol; controlling the flow of material and product under investigation; general monitoring of activities and records, data collection, provide training and technical and scientific support to the team of the Research Center and Principal Investigator, the developer activities of SOPs, Preparer and reviewer of documents for regulatory submission.

Acting as Specialist in Clinical Research - Scientific Support Sr. - (Jun / 14 to Feb / 16): Preparer and Clinical Development Briefings reviewer Medicines (DCDD - RDC 09/2015 - ANVISA), including Development Plan, Brochure of Researcher, Special Dossier and Dossier of Experimental Medicine, Critical Analysis Pre Clinical and Clinical Reserachs. It is part of the preparation of the Technical Scientific Rationale for Clinical development of medicines including pre submission meetings with ANVISA. Audit in Clinical Studies with an emphasis on GCP-ICH. Constant updating of laws and national and international guidelines and Ethical flow. Makers of SOPs and forms for carrying out the activities of the area. activity implementer "start up" in Clinical Research as selection and initiation of research centers, Development of the regulatory package, contract, control of the investigational product, document control, preparation of regulatory folders, preparing the content of medical records, e-TMF system, registration Study on platforms and support the study. Training and monitoring of monitors and organization of content and schedule of activities. Responsible for relationships with CROs.

Acting as CRA (Jun / 2010 to May / 14): Monitoring of Clinical Trials (Phases I to IV) and Bioequivalence (Steps Clinic, Analytics and Statistics) comprising activities: Preparation of reports, Plan of monitoring, ensuring compliance with GCP , GLP and existing regulations; Study initiation and close out, ensure compliance with the clinical protocol; controlling the flow of material and product under investigation; general monitoring of activities and records, data collection, provide training and technical and scientific support to the team of the Research Center and Principal Investigator, preparation and study protocol assessment, the developer activities of SOPs.

Acting as RD&I Analyst (Mar / 08 to May / 10): Responsible for the development and analytical methods validation methodology and relevant documentation; Studies Stability of pharmaceutical and cosmetic products, experience in Dissolution Profile Comparison and Pharmaceutical Equivalence in REBLAS laboratory. theoretical and practical knowledge in HPLC, UPLC, GC, UV-VUS, IR, OES / ICP (Plasma), LC - MS / MS.

Acting as Analytical Development Analyst and Quality Control (2007): Responsible for physical and chemical analysis routine, stability analysis and validation of analytical methods, sampling, experience with analytical equipment (HPLC, GC, UV-VUS, IR, OES / ICP (plasma)).