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프린트
전체 257건, 현재 페이지 9/26
GPKOL
임상 인허가
말레이시아
- Clinical Trial : Many aspects of drug development focus on satisfying focus on satisfying the regulatory requirements of drug licensing authorities. These generally constitute a number of tests designed to determine the major toxicities of novel compound prior to first use in humans. It is a legal requirement that an assessment of major organ toxicity be performed(effects on the heart, liver, lungs and kidney) as well as effects on other parts of body that might be affected by drug. - Regulatory Affairs : Managing international regulatory issues and developing new regulatory policies and training of employees planning of new strategies to get products approved by government and engaging in post-marketing surveillance of products. Monitoring and follow up with Regulatory authorities for approval regulatory issues at National & international Level.
인허가 임상
미국
- Clinical Trials : First in Human studies, Phase 1,2,3 and 4 studies – clinical trial strategies - RA : Regulatory strategies and interactions with FDA(regulatory submissions)
PM 기술마케팅
캐나다
- Project Management: Globalization and market entry in Canada, specializing in helping pharmaceuticals, healthcare companies and start-ups. Facilitate joint ventures, partnerships, research regulations with Health Canada and local provinces, assess competitive landscape, perform trade interviews and recommend sustainable market entry mode. Planning and Execution of all phases of market entry in Canada. - Technical and Marketing strategic planning and global execution.
R & D기획
- R&D planning: Drug Discovery research in cardiovascular, metabolic disease, antiviral and inflammation/immunology areas
임상 인허가 PM
- Clinical Trial: Expertise in designing, planning, and executing domestic and international Phase I-III clinical trials. Prepare clinical development documents, including but not limited to, protocols, IBs, operational documents/SOPs, and development plans. - Regulatory Affairs:Provide regulatory strategy guidance; prepare regulatory meeting background packages, clinical modules for INDs, CTAs, NDAs, and MAAs. - Project Management: Global CRO selection and management; project management to cover overall pharmaceutical development
기술마케팅 PM
브라질
- Technical Marketing and Project Management
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
- 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&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