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프린트
전체 251건, 현재 페이지 9/26
GPKOL
임상
러시아
- Clinical Trials - Pre-Clinical Trials - Audits
대한민국
- Statistical expert in Phase 1- IV clinical trial design and statistical analysis including development and review of protocol, Statistical analysis plan (SAP) or data management plan (DMP) - Communication with FDA and EMA regarding statistical matter in IND, End of phase 2 meeting, NDA and RTQ (response to questions after the submission) - Statistical strategy for the drug development plan, specialized in Vaccine, inflammation disease area and biosimilar - Data Monitoring Committee
캐나다
- 임상시험 I/II/III 상 설계 디자인 및 프로토콜 작성 - 표본수 및 검증력 계산, 데이터 분석 계획, 무작위 배정 설계 - 데이터 분석 및 분석결과 해석
R & D기획
R&D 기획 - CDMO & CRO collaboration - China 연구 CROs Networking and Collaboration - API Tech transfer - Process developemnt & Optimization - China Pharma company networking - Formulation study (polymorphism, slat screening, single crystal, etc) collaboration
기술마케팅 임상 PM
브라질
- Marketing: o BD deals signed in various countries of Latin America o Start up of oncology, neuroscience and hospital care BU in Chile o Launch of Cymbalta and Zyprexa in Brazil - PM: o Set up of the whole value chain for launches of Branded Generics in Latin America o Alliance management in Latin America with Pfizer, Boehringer, Otsuka and Indian Vendors o Leadership of budget process in Latin America - Clinical Trials: o Leadership of internationalization process of Techtrials and partnership deals signed with different global CRO o Consultancy in “Go-To-Market” Projects which involve guidance on regulatory, R&D and commercial aspects
GMP 인허가
미국
- GMP:GMP/GLP compliance audits of API and Drug Product CMO, Quality Risk Assessment,General QA Activities and GMP/GLP Training and Education - Regulatory Affairs(RA):Dossier preparation for IND, IMPD, NDA, MMA for both DS and DP modules, CMC Regulatory strategies and ICH Guideline compliance - CMC Project Management:Global CDMO selection and management, project management for both chemical and Pharmaceutical Development
기술마케팅 인허가
- Technical Marketing : Expert in marketing and commercialization models for US and EU markets - Regulatory Affairs : Expert in FDA accelerated pathways and biosimilar pathways, and their implications for commercialization
PM 임상
- Clinical Research : Product registration, Marketing Launch, and Market Access in Asia Pacific, EU and USA - Project Management : Portfolio management in the Clinical trial, Looking for new business potential and extend product lifecycle in APAC region, and Marketing strategic planning and execution
기술마케팅 임상
- Work with pharmaceutical and Biotech companies in discussing their registration plans in Aisa, Japan, and EU - Discuss various partnership models to enable access to Aisa and Japan. - Generation of clinical development plans for registration strategy in Asia, China, Japan and the Rest of the world.
임상 인허가
- Drug Safety : Establishing and updating drug safety profile in clinical trials and post-marketing such as case identification, validation, medical coding, ICSR submission, RMP and PSUR, etc. - Medical Review : Providing high quality creative solutions for all phases of trial such as line-listing review, participation in DSMB, IEC/IRB meeting, etc. - Regulatory Affairs : Having applied knowledge and deep understanding of local (Roszdravnadzor in Russia, CFDA in China) and global regulatory requirements. - Audits : Conducting along with regulatory authorities participate in assessment of existing drug safety systems - Safety Database : E2B, EudroVigilance compliant, and specific Russian regulatory requirements.