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프린트
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GPKOL
임상
미국
Setting clinical and medical affairs strategy and executing across all clinical programs; leading a clinical operations team developing a novel, first-in-class, small molecule SHIP 1 activator, as well as participating as a key member of executive management team: 1) FLAGSHIP trial in acute exacerbations of COPD using the novel EXACT-PRO 2) LEADERSHIP trial in Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC) 3) KINSHIP trial in mild to moderate Atopic Dermatitis (AD) 4) Corporate development activities –. taking company public and ensuring sufficient funds available to complete CMC, nonclinical, clinical and corporate development programs
대한민국
비임상 인허가
비임상
인허가 GMP
- CMC: Technical/regulatory advices on gene therapy, biosimilar or biotechnology products development (i.e., manufacturing process, QC specifications, comparability, CRO/CMO, etc.) - RA: Regulatory strategies and interaction with US FDA for preclinical , clinical, BLA, and postmarketing preparation - GMP: regulatory guidance and manufacturing facility inspections
캐나다
- 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
R & D기획
에콰도르
- R&D Planning - Clinical Trial - GMP - Regulatory Affairs (RA)
R & D기획 임상 GMP
