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

GPKOL 자문위원 리스트

전체 255건, 현재 페이지 6/26

• 
  박준태(Jun Park)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가
    GMP

  • 컨설팅 대상 지역

    대한민국

  • 컨설팅내용

    - CMC: Technical/regulatory advices on gene therapy, biosimilar or biotechnology products development (i.e., manufacturing process, QC specifications, comparability, CRO/CMO, etc.)
    - RA: Regulatory strategies and interaction with US FDA for preclinical , clinical, BLA, and postmarketing preparation
    - GMP: regulatory guidance and manufacturing facility inspections
    

  상세프로필 컨설팅 신청
• 
  Jessica Liu

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    임상

  • 컨설팅 대상 지역

    중국

  • 컨설팅내용

    1. Clinical Development Plan : Develop TPP and CDP according to company strategy and produce profile as well the therapeutic area guidelines.
    2. Clinical Trial : Project management on full function study team, Outsourcing Management, Clinical Operation team management, China GCP.
    3. China Regulatory Policy : China IND to NDA, Global Development Strategy for China market

  상세프로필 컨설팅 신청
• 
  Xiaoyuan Chen

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획
    임상
    인허가

  • 컨설팅 대상 지역

    중국

  • 컨설팅내용

    1. R&D Planning for oncology drug
    2. Clinical Trial design and implementation in oncology area
    3. Regulartory Affairs(RA)

  상세프로필 컨설팅 신청
• 
  Valquiria Kopke dos Santos

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    GMP

  • 컨설팅 대상 지역

    브라질

  • 컨설팅내용

    1) Planning, )Management and Conduct of validation activities (Cleaning, Water System for Injectables and Purified Water, Compressed Air Pharmaceutical Grade, Nitrogen, Transport, Generation and Distribution of Pure Steam, Transport, Aseptic Filling - Media Fill, Sterilizing Filtration and Productive Process
    2) Elaboration / Review of the Validation Master Plan and Technical Documentation regarding Validation (Protocols, Validation Plans and Reports).
    3) Non-Conformity Management.
    4) Qualification of operators to carry out activities in clean areas.
    5) Training in Good Manufacturing Practices (GMP).
    6) Audit of Good Manufacturing Practices (GMP).
    7) Monitoring the qualification and calibration of instruments.

  상세프로필 컨설팅 신청
• 
  Qinmin Yang

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획

  • 컨설팅 대상 지역

    중국

  • 컨설팅내용

    제제 연구개발(약물 제제 처방기술 개발 药物制剂处方工艺开发)

  상세프로필 컨설팅 신청
• 
  Jack Wong

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가

  • 컨설팅 대상 지역

    싱가포르

  • 컨설팅내용

    Over 20 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products. Received awards on improving process (reduced 20% time in product launch time) and developing People (Watson Wyatt Survey to all direct reporting staff indicated that 100% of them able to contribute to their fullest ability).
    
    Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 2800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with over 3600 members. Wrote the first Asia Regulatory Book in Asia, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.
    
    Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by BSI (British Standards Institution)

  상세프로필 컨설팅 신청
• 
  Ng Yin Mei

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가
    기술마케팅

  • 컨설팅 대상 지역

    싱가포르

  • 컨설팅내용

    1. Regulatory, Quality and Project management ; Medical Device, IVD, Combination Drug-device, pharmaceutical, health supplement, cosmetic. Health software
    -R&D planning (DHF Design control), CMC/Quality advisory (DMF), Risk
    -Clinical trial (Performance/Clinical evaluation plan/report, Post market surveillance plan/report), Clinical trial protocol, application, funding and clinical trial sites with Singapore Hospitals.
    -Quality management system (ISO13485, MDSAP, GMP Brazil/Japan, US QSR, GMP compliance set-up, validation and warning letters solution team)
    -Regulatory Affairs (Regulatory Strategy for CE/US/Asia/Country of origin) for product approval of medical device, drug, cosmetic, AI, Software standalone or in device.
    
    2. Technical marketing ; Medical Device, IVD, Combination drug-device, drug
    -To provide training and consulting on overseas expansion strategy and marketing channel development in such case of Korean companies’ market expansion into emerging countries
    -To establish partner network for each market and region, especially on technology collaboration with Singapore researcher and investor

  상세프로필 컨설팅 신청
• 
  한민준(Min-Joon Han)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획
    GMP

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    (R&D기획) Patient derived iPSC to recapitulate in vitro disease model and drug screening
    (GMP) Large scale stem cell production

  상세프로필 컨설팅 신청
• 
  Antonia Maria Cavalcanti de Oliveira

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    GMP

  • 컨설팅 대상 지역

    브라질

  • 컨설팅내용

    - 브라질 PDP(Productive Development Partnership) 프로그램 기술이전(TT) 매니지먼트
    - 기술이전 관련 품질관리 파트 컨설팅
    - 약물 stability test, forced degradation test 관련 컨설팅
    - 약물개발 및 밸리데이션

  상세프로필 컨설팅 신청
• 
  한우석(Wooseok Han)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    - 초기 물질 발굴(의약화학)
    - 최적화 프로그램 의사결정, SAR 개발, 전임상 후보물질 합성
    - 후보물질에 대한 임상시험 진행 등

  상세프로필 컨설팅 신청

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