Maurício Sampaio

Technical and administrative manager of planning and conducting bioequivalence and bioavailability studies. Responsible for capturing and introducing to the area of expertise the knowledge of the mathematical modeling technique used in research and development of pharmaceutical drugs to predict absorption, distribution, metabolism and excretion (ADME), as well as introducing concepts for conducting bioavailability studies with greater technical complexity. Responsible for managing the team so that the established goals were achieved for 5 consecutive years. Team encouragement and motivation is the main purpose.

Technical and administrative coordinator of the planning and conduction of bioequivalence and bioavailability studies (pharmacokinetics and/or pharmacodynamics) aimed at registering generic, similar and new drugs. Solid technical and regulatory knowledge of the clinical, analytical and statistical stages of bioequivalence / bioavailability studies in accordance with the guidelines and guidelines established by: ANVISA, FDA, EMA, MHRA, Health Canada and USFDA (India). Responsible for the indication and evaluation of the physiological and biorelevant midia that complement the in vitro tests previously performed to the in vivo test. Member of the Biopharmacy internal group supporting the evaluation of formulations in order to correlate their performance with the expected behavior of the present drug in relation to its class in the Biopharmaceutical Classification System (BCS).

company, as well as the development of new suppliers and the establishment of contracting research centers, especially those of bioequivalence and clinical research.

Ensure the reliability of data from the development and validation of bioanalytical methods for studies of bioequivalence and bioavailability through the application of the LC-MS/MS technique (Liquid Chromatography coupled to detection by mass spectrometry).

Executing the activities of development and validation of bioanalytical methods for studies of bioequivalence and bioavailability through the application of the LC-MS/MS technique (Liquid Chromatography coupled to detection by mass spectrometry).

esponsible for validating drug manufacturing technology transfer processes between BI's global units to Brazil unit. Responsible for carrying out disintegration and dissolution tests on formulations. Responsible for the preparation of troubleshooting reports aimed at the systematic and logical search for the root of a problem so that the product or process can be operational again.

Supervision of the production process of solid and antiretroviral drugs. Responsible for guiding, supervising and training approximately 90 employees in order to ensure Good Manufacturing Practices in the production of medicines.

Production management of solid and liquid medicines implementing the concepts of Good Manufacturing Practices (GMP) and PDCA in the control and continuous improvement of processes and products. Responsible for implementing all Operating Procedures (POPs).

Address to access this CV: http://lattes.cnpq.br/0832096680319748

1) Introduction to Project Management 2) Project Lifecycle and Organization 3) Project Management Processes 4) Project Integration Management 5) Project Scope Management 6) Project Time Management 7) Project Cost Management Project 8) Project Quality Management 9) Project Human Resources Management 10) Project Communications Management 11) Project Risk Management 12) Project Procurement Management

Specialization focused on Good Manufacturing Practices in force in the Pharmaceutical Industry; Production and distribution of high quality air for classified areas; Technology of dry dosage forms; Heterogeneous and Highly dispersed systems; Production, storage, distribution, control and validation of water treatment systems for pharmaceutical use; Production of drugs for small and large volume parenteral use; Principles and procedures of industrial sterilization; Packaging materials for pharmaceuticals; Bioavailability & Bioequivalence; R&D and automation in the pharmaceutical industry; Biotechnological processes in pharmaceutical products; Pharmaceutical management and administration; Pharmaceutical ethics and legislation; Scientific research methodology.