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

GPKOL 자문위원 리스트

전체 119건, 현재 페이지 11/12

• 
  이정재(JungJae Lee)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    1. R&D Planning : All projects include R&D Planning, Clinical Trial, GMP, RA, Technical & Marketing, and PM through collaborations with Pharmaceutical companies and Medical Centers: MTTI (www.mtarget.com, PA, USA), Precision Membranes (www.precisionmembranes.com, UT, USA), BostonSight (www.bostonsight.org, MA, USA), MEEI (www.masseyeandear.org, MA, USA) and Anschutz Medical Campus (www.cuanschutz.edu, CO, USA).
    2. Drug Delivery Systems (DDS) for Cancer Treatment.
    3. Molecular Imaging (MI) for Cancer Detection
    4. Therapeutic Contact Lens for Eye Diseases
    

  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
• 
  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
• 
  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
• 
  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

  상세프로필 컨설팅 신청
• 
  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.

  상세프로필 컨설팅 신청
• 
  방성윤(Bang Seong Yun)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    임상

  • 컨설팅 대상 지역

    대한민국

  • 컨설팅내용

    - GCP Managment/START-up(Country&Site approach&selection)/Trial Operation Management
    - Global Project Start-up & Management/Technology & Process/Business Development
    - Quality Managment for Clinical part/Auditing & CAPA strategy
    - Resource & talent training in bio-industry (Productivity & efficiency management)
    - EP unit set up & business

  상세프로필 컨설팅 신청
• 
  Sergio José Mecena da Silva Filho

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    인허가

  • 컨설팅 대상 지역

    브라질

  • 컨설팅내용

    - Innovation: Manager of Business Incubator, Technological Park, Venture Capital Fund, Research Labs and Institute of Innovation, R&D Planing and execution for drug development, and Management of Research Groups.
    - Life Science: Manager of the Technological Park of Life Sciences, Project Leader of Drug Development, PDP program developer and Manager, Designer of partnership architecture to technology transfer for drug development, Designer of International Program Alliances(South Korea, France, US, Europe)
    - Regulatory: Developer of Strategic Planning for ANVISA, Designer of Prganizational structure for ANVISA, Designer of the Knowledge Regulatory Affairs Reference Center, Good Laboratories & Manufacturing Practices Registration, Pre-Clinical and Clinical Trials Planning.

  상세프로필 컨설팅 신청

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