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

GPKOL 자문위원 리스트

전체 117건, 현재 페이지 11/12

  • 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

  • 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.

  • 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.

  • 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

  • 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.

  • 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

  • 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.

  • 이재원 (Jaewon Lee)
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      영국

    • 컨설팅내용

      - Psychiatry
      - General psychiatry including Schizopherenia and depression
      - Neurodegenerative disorder
      - Parkinson's disorder and Dementia
      - Pharmaceutical Science
      R&D Planning, Clinical Tiral, Regulatory Affairs(RA), Pricing and Reimbursement, Business evelopment(Licensing)

  • 홍빅터 (Victor Sukbong Hong)
    • 컨설팅 구분

      GPKOL

    • 컨설팅 분야

      R & D기획

    • 컨설팅 대상 지역

      대한민국

    • 컨설팅내용

      CHEMIST AND BIOCHEMIST with extensive drug discovery experience at pharmaceutical and biotech companies supplemented by broad academic research background. Advanced skills in protein and enzyme analyses, mechanistic enzymology, high-throughput screening, and enzyme/cell assays. Adept with pre-clinical drug development including target identification, lead discovery, and optimization. Exceptional researcher and collaborator with Medicinal Chemists and Biologists.