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GPKOL
R & D기획 임상
미국
R & D기획 인허가
일본
- R&D : 연구/개발 전략 & 기획 : IP 전략 - 인허가 : 일본 인허가 전략 수립 : 후생성, PMDA communication 업무(통역) : 문서 작성 업무 : 일본 문서(규정) 번역
인허가
중국
- 의약품 등록/판매허가 - 국제협력 프로그램 - 식품안전관리조정
R&D기획 1. drug discovery and development/ lead optimization/pharmacology/PK&PD/biomarkers and diagnostics/toxicology/pharmaceutics(CMC)/clinical development and regulatory requirements for small molecule and therapeutic antibody 2. Expertise in research strategic planning and mangement of projects 3. strong experience in building and constructing business plan and managing start-up biotech company(co-founder of PharmAbcine) 4. strong industry experiences in global biotech and pharmaceutical companies including Chiron (currently Novartis), AstraWeneca, Genentech and Exelixis 임상 1. IND, clinical protocol, investigator brochure 작성 2. leading clinical management/operation 3. biomarkers and diagnostic strategy in clinical trials
기술마케팅
A biochemist and molecular biologist with 15 years of pharmaceutical and biotechnology company experience focusing on protein biochemistry, assay development, and drug discovery in the areas of oncology and metabolic diseases. Extensive experience in preclinical research and lead optimization for small molecule drugs as well as protein therapeutics with project leading and team management.
- Oncology/ Gynecology Oncology - Drug Development - Clinical Research - Medical Affairs - Health Outcomes - Health Care Management
대한민국
* Improving patient access in Global & Emerging markets: Achieved optimal pricing approval between internal and external parties as Chair of the Regional Pricing Committee, with the operationalization of the Global Access and Pricing Strategy. Led the Innovative access programs in emerging markets providing strategic. Developed frontier strategies for better accessible and affordable healthcare in APAC region. Influenced internal and external stakeholders to shift price-volume to value-d access. Promoted and advocated equitable pricing methodology for better patient access (UCB Pharma). * Credible win-win partnership with stakeholders: Built a platform for the access expansion in international markets, leading the business negotiation, license in/out and governmental partnering programs (MTAC: Medical Treatment Adherence Clinics in Malaysia, CME for governmental health agencies in S. Korea, Taiwan, Thailand and Malaysia) Achieved WHO’s resolution for Psoriasis, improving patients access for optimal treatment with patient groups and WHO representatives. Advocated innovation of R&D, better patient access and ethical business practice through industry association and local government agencies with diverse partnership, programmes, and shaped external environment (LEO Pharma & MSD). * Executing Health Ecosystem Strategy: Developed the future ecosystem and payer strategy which set the global business direction and provided future vision. Oversaw the trend to shape external environment to strengthen payer engagement and partnerships with non-healthcare and leading digital transformation providers. Prepared recommendations to C-Suite and senior leadership team to promote sustainable healthcare and digital transformation within the long-term corporate strategies (UCB Pharma). • Global Patient Access • Value Strategy Formulation and Execution • Health Policy and Advocacy • Health Equity and Affordability • Partnerships: Government, Academia, Public & Media • People Leadership, Coaching and Mentoring • C-Suite and Board Engagement • Strategy and operational Excellence
인허가 GMP 인허가 GMP 인허가 GMP
브라질
- Regulatory Quality Compliance. - Regulatory Affairs including product approvals and establishment of the companies (sanitary operational license and authorization). - Post-marketing surveillance (mandatory and voluntary notifications | treatement of adverse events claims) - Regulatory strategy. - Good Manufacturing Practices certification (planning, prepare, audits). - Regulatory support on import process. - Change management with uation of regulatory impact. - Risk management. - Due diligence for acquisitions.
태국
- Thailand Law and regulation on biological products (Biopharmaceuticals, Biosimilars, Vaccines, Blood products, ATMPs) - Regulatory science for pharmaceutical/biopharmaceuticals - Policy development on pharmaceuticals/biopharmaceuticals
