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

GPKOL 자문위원 리스트

전체 115건, 현재 페이지 10/12

• 
  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
• 
  Eunsil Yim (임은실)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    임상

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    - 임상 통계 컨설팅, 임상시험 Ⅰ/Ⅱ/Ⅲ 상 설계 디자인 및 프로토콜 작성
    - 표본수 및 검증력 계산, 데이터 분석 계획 및 분석 결과 해석
    - 미국 CRO 선정 및 관리
    - CDISC (SDTM, ADaM)전문가
    - 항암 스터디 설계 및 분석 전문

  상세프로필 컨설팅 신청
• 
  양치원 (Chiwon Yang)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    GMP

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    품질 시스템 실행
    업체 시설의 연방(U.S. Federal) 기준 준수 관리
    내부 감사를 통한 시설의 규제 및 절차에 대한 준수상황 관리
    시설 준비/연방 검사 대비

  상세프로필 컨설팅 신청
• 
  Jee Eun Lee (이지은)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가
    R & D기획

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    [Regulatory Science]
    - Regulatory principles and procedures regarding IND, NDA, BLA for developing drug candidates
    
    [Trial Design/R&D strategy(Clinical Pharmacology]
    - Translational science utilizing pharmacokinetics and pharmacodynamics data to predict clinical efficacy and safety
    
    [Trial Design/R&D strategy(Modeling and simulation)]
    - Population approach to pharmacokinetics/pharmacodynamics data
    - Statistical/mechanistic analysis and modeling to predict clinical efficacy and safety
    
    
    

  상세프로필 컨설팅 신청
• 
  Sungtae Kim (김성태)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    (R&D Planning) Disease selection, Target ID/validation, Target commitment
    (Technology) Functional genomics tools, target modality/tractability assessment

  상세프로필 컨설팅 신청
• 
  Anthony Hoerning

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    기술마케팅

  • 컨설팅 대상 지역

    스위스

  • 컨설팅내용

    - Alliances: Improvement of (portfolio) of alliances; processes (finance, legal, communications, decision marketing and governance, negotiation)
    - Business Development & Licensing: Seeking partnership; defining own strategic needs and wants; defining licensing strategy, approaching relevant players; prioritizing and negotiating.
    - Externalisation strategy: Make vs go-get decisions; financing vs partnering; identifying financial and strategic partnership models which align with strategic intent; communicating with investors and partner companies.

  상세프로필 컨설팅 신청
• 
  Asma Mahmoud Nimer Hammad

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가
    PM

  • 컨설팅 대상 지역

    요르단

  • 컨설팅내용

    1. Regulatory Affairs
    - Establishing the strategic direction and execution of regulatory strategies with MENA(Middle East and North Africa)
    - Collaborating with senior management to provide planning, development and implementation of appropriate regulatory strategies/processes to ensure ongoing compliance with regulatory requirements for the targeted markets
    - Providing regulatory expertise and ensures appropriate regulatory guidance and support is provieded to development teams across the region
    - Providing insights and continual research into future direction of corporate Regulatory Affairs and how to best prepare, trends, regulations and changes, enabling company to take a proactive approach and proactive planning to future business requirements.
    2. Project Management for key strategic regulatory projects with cross functional teams

  상세프로필 컨설팅 신청
• 
  Marina Cortes

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    PM
    기술마케팅

  • 컨설팅 대상 지역

    캐나다

  • 컨설팅내용

    - 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.

  상세프로필 컨설팅 신청
• 
  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

  상세프로필 컨설팅 신청

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