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

GPKOL 자문위원 리스트

전체 115건, 현재 페이지 11/12

• 
  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
• 
  박정수 (Jungsoo Park)

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    기술마케팅

  • 컨설팅 대상 지역

    오스트리아

  • 컨설팅내용

    Technical Marketing
    Global marketing fr biotech-related products and services

  상세프로필 컨설팅 신청
• 
  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)

  상세프로필 컨설팅 신청
• 
  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.

  상세프로필 컨설팅 신청
• 
  손우찬

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    R & D기획

  • 컨설팅 대상 지역

    대한민국

  • 컨설팅내용

    Engaged in teaching and research in the pathology department. Teaching of experimental animal pathology. Providing consultancy in the area of comparative pathology. A member of IRB in Asan Medical Center. Advisory activities with the clinical study groups in the Hospital. Leading the experimental pathology conference. Organised the consultancy group together with early clinical clinicians, PRISM, providing consulting service to pharma industries.
    
    Have been involved in the gross and histopathological examination of a wide range of laboratory species from short-term to long-term toxicological studies. Special interests are preclinical safety evaluation and academic research areas are GEM (Genetically Engineered Mice) pathological phenotyping.

  상세프로필 컨설팅 신청
• 
  Deirdre Tessman

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    임상
    PM
    인허가

  • 컨설팅 대상 지역

    프랑스

  • 컨설팅내용

    Project Management
    As Global Project Director led teams to develop and obtain marketing approval in parallel in Europe and America involves trouble shooting, contingency planning and coordination of and communication with team members, investígalo rs, reguiatory authorities and sponsor company. Knowledge in all aspects of Drug Development.
    
    Reguiatory
    Researched fast track and Orphan drug strategies and applied for and received special designations from FDA and EMEA under which the drugs were approved, resulting in shorter timelines and reduced fees (saving money and time). Developed good working relationships with reguiatory authorities. Have filed 505 (b)(l), 505 (b)(2)applications withsuccess.
    
    Clínica! Triáis
    Determine the best strategy for conduct of clinical studies wíth a balance between speed and costof studies in different countries. Also the regulatory differencés in obtaining clinical trial a p pro vals are.taken into consideraron. Havedeveloped a large network of Investigators, especially in oncology.

  상세프로필 컨설팅 신청
• 
  Eunjoo Pacifici

  • 컨설팅 구분

    GPKOL

  • 컨설팅 분야

    임상

  • 컨설팅 대상 지역

    미국

  • 컨설팅내용

    임상실험, 임상개발 치료, 제품개발(특히 아시아 태평양 및 남미 지역), 규제과학

  상세프로필 컨설팅 신청

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