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프린트
전체 257건, 현재 페이지 12/26
GPKOL
R & D기획
- Drug Discovery(R&D): Structure-based drug design in cancer, neurodegenerative diseases (Parkinson’s Disease), malaria and dengue
인허가
브라질
- GMP: Quality System management and Good Drug Manufacturing Practices. - RA: Preparation and submission of generic and biological drug registration dossiers with ANVISA.
- Innovation: Manager of Business Incubator, Technological Park, Venture Capital Fund, Research Labs and Institute of Innovation, R&D Planing and execution for drug development, and Management of Research Groups. - Life Science: Manager of the Technological Park of Life Sciences, Project Leader of Drug Development, PDP program developer and Manager, Designer of partnership architecture to technology transfer for drug development, Designer of International Program Alliances(South Korea, France, US, Europe) - Regulatory: Developer of Strategic Planning for ANVISA, Designer of Prganizational structure for ANVISA, Designer of the Knowledge Regulatory Affairs Reference Center, Good Laboratories & Manufacturing Practices Registration, Pre-Clinical and Clinical Trials Planning.
임상
- Clinical Trial: Monitoring of clinical trial related to Regular Heparin - Science Publishing: Member of Publishing Service of Wolters Kluwer Pharma Solutions - Business Development: Several Projects to become in products following steps in RA, GMP inspections Marketing, R&D
PM 기술마케팅
- Project Management: Developing the internationalization project from Brazilian companies in international events. - Technical & Marketing
미국
- Onclogy: Clinical Development, Clinical Trials
R & D기획 임상
- R&D Global Clinical Operation(Biostatistics)
중국
R&D기획
R&D Planning: Anti-cancer drug, Anti-parasite drug discovery, Anti-HIV drug discovery
- PK and drug metabolism SME with 15 years of experience in drug discovery and development - Represented preclinical PK in multidisciplinary drug discovery and development team meetings for various therapeutic indications (oncology, metabolic disorder, anti-inflammation, infectious disease) - Extensive experiences in translating preclinical data to predict human PK properties - Thorough understanding of all aspects of drug discovery and development - Authored more than 50 IND-enabling PK/TK/ADME study reports and prepared relevant sections for IND, NDA/BLA, and other regulatory documents (IB, Briefing Book, responses to FDA/EMEA/PMDA)
