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컨설팅 신청

home > 전문가 컨설팅> 온라인 컨설팅서비스> 컨설팅 신청

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GPKOL 온라인 자문 신청서 양식 다운로드(신청자 회사 소속확인, 회사직인)

GPKOL 자문위원 리스트

전체 251건, 현재 페이지 9/26

  • Evgeny Rogoff
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상

    • 컨설팅 대상 지역

      러시아

    • 컨설팅내용

      - Clinical Trials
      - Pre-Clinical Trials
      - Audits

  • 전연
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상

    • 컨설팅 대상 지역

      대한민국

    • 컨설팅내용

      - 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

  • 임현자
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상

    • 컨설팅 대상 지역

      캐나다

    • 컨설팅내용

      - 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

  • 권호영
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      대한민국

    • 컨설팅내용

      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

  • Fabio Augusto Deleuse
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      기술마케팅
      임상
      PM

    • 컨설팅 대상 지역

      브라질

    • 컨설팅내용

      - 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

  • Kay Olmstead
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      GMP
      인허가

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

      - 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

  • Sheela Hegde
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      기술마케팅
      인허가

    • 컨설팅 대상 지역

      미국

    • 컨설팅내용

      - 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

  • Siri Leksuwat
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      PM
      임상

    • 컨설팅 대상 지역

    • 컨설팅내용

      - 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

  • Vishal Doshi
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      기술마케팅
      임상

    • 컨설팅 대상 지역

    • 컨설팅내용

      - 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.

  • Yuri Zaretsky
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      임상
      인허가

    • 컨설팅 대상 지역

      러시아

    • 컨설팅내용

      - 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.