컨설팅 신청

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

다운로드 GPKOL 신청서 표지 워드파일 다운로드 GPKOL 신청서 내용 워드파일 다운로드

GPKOL 자문위원 리스트

전체 256건, 현재 페이지 9/26

안해영
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  인허가
  임상
- 컨설팅 대상 지역
  미국
- 컨설팅내용
  - Clinical Trials : First in Human studies, Phase 1,2,3 and 4 studies – clinical trial strategies
  - RA : Regulatory strategies and interactions with FDA(regulatory submissions)
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.
고수성
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  R & D기획
- 컨설팅 대상 지역
  미국
- 컨설팅내용
  - R&D planning: Drug Discovery research in cardiovascular, metabolic disease, antiviral and inflammation/immunology areas
MiRa Huyghe
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  임상
  인허가
  PM
- 컨설팅 대상 지역
  미국
- 컨설팅내용
  - Clinical Trial: Expertise in designing, planning, and executing domestic and international Phase I-III clinical trials. Prepare clinical development documents, including but not limited to, protocols, IBs, operational documents/SOPs, and development plans.
  
  - Regulatory Affairs:Provide regulatory strategy guidance; prepare regulatory meeting background packages,
  clinical modules for INDs, CTAs, NDAs, and MAAs.
  
  - Project Management: Global CRO selection and management; project management to cover overall pharmaceutical development
Norberto Prestes
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  기술마케팅
  PM
- 컨설팅 대상 지역
  브라질
- 컨설팅내용
  - Technical Marketing and Project Management
Evgeny Rogoff
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  임상
- 컨설팅 대상 지역
  러시아
- 컨설팅내용
  - Clinical Trials
  - Pre-Clinical Trials
  - Audits
전연
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  임상
- 컨설팅 대상 지역
  대한민국
- 컨설팅내용
  - Statistical expert in Phase 1- IV clinical trial design and statistical analysis including development and review of protocol, Statistical analysis plan (SAP) or data management plan (DMP)
  - Communication with FDA and EMA regarding statistical matter in IND, End of phase 2 meeting, NDA and RTQ (response to questions after the submission)
  - Statistical strategy for the drug development plan, specialized in Vaccine, inflammation disease area and biosimilar
  - Data Monitoring Committee
임현자
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  임상
- 컨설팅 대상 지역
  캐나다
- 컨설팅내용
  - 임상시험 I/II/III 상 설계 디자인 및 프로토콜 작성
  - 표본수 및 검증력 계산, 데이터 분석 계획, 무작위 배정 설계
  - 데이터 분석 및 분석결과 해석
권호영
- 컨설팅 구분
  GPKOL
- 컨설팅 분야
  R & D기획
- 컨설팅 대상 지역
  대한민국
- 컨설팅내용
  R&D 기획
  
  - CDMO & CRO collaboration
  - China 연구 CROs Networking and Collaboration
  - API Tech transfer
  - Process developemnt & Optimization
  - China Pharma company networking
  - Formulation study (polymorphism, slat screening, single crystal, etc) collaboration
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