저자의 연구 키워드

저자의 연구 키워드

#「 생명윤리및안전에관한법률」

#기관생명윤리위원회

#동물권(Animal rights)

#바이오뱅크

#백지동의

#사전예방원칙(Precautionary principle)

#생명윤리및안전에관한법률

#생물의약품

#수탁원칙(Trusteeship principle)

#신속개발

#신속승인

#신속처리

#신약

#신약승인신청

#연구대상자 보호

#연구대상자보호

#우선심사

#위험기반 접근법

#위험평가와 완화전략

#유럽의약품청

#유전자치료연구

#이종이식(Xenotransplantation)

#인간대상연구

#인체유래물

#임상시험

#임상시험 보류처분

#임상시험계획승인신청

#임상시험수탁기관

#임상시험심사위원회

#재생의료

#재조합 및 합성 핵산 분자 포함 연구 가이드라인

#재조합 DNA 자문위원회

#전임상시험관리기준

#줄기세포 연구의 규제

#줄기세포 중개연구

#줄기세포기반치료

#줄기세포연구

#중앙허가제

#첨단치료 위원회

#첨단치료 의료제품

#충분한 설명에 의한 동의

#충분한 설명에 의한 동의(Informed consent)

#충분한 정보에 근거한 동의

#충분한 정보에 의한 동의

#커먼룰

#커먼룰(Common Rule)

#혁신치료지정

#Accelerated Approval

#Advanced Therapy Medicinal Products(ATMPs)

#ATMP법

#Biobank

#Bioethics & Safety Act

#Bioethics and Safety Act

#Bioethics and Safety Act(BEASA)

#biologics

#Biospecimens

#Blanket Consent

#breakthrough therapy designation

#Centralizedauhorization system

#Clinical Hold

#Clinical Trials

#Committee for Advanced Therapies(CAT)

#Common Rule

#Contact Research Organization(CRO)

#due process

#ESCRO 위원회

#ESCRO Committee

#European Medicine Agency(EMA)

#fast track

#Fast Track Mechanism

#FDA 등록거부권

#FDA 자문위원회

#FDA Advisory Committees

#FDA Refuse to File

#Gene Therapy Research

#Good Laboratory Practices(GLPs)

#Human Genetics Commission

#Human Subject Research

#human subjectsresearch

#informed consent

#Informed Consent(IC)

#Institutional Review Board

#Institutional Review Board(IRB)

#Investigational New Drug Application(IND)

#Korea Good Clinical Practice(KGCP)

#National Bioethics Advisory Committee

#National Bioethics Deliberative Council

#National Consultative Ethics Committee for Health and Life Science

#National Ethics Council

#New Drug

#New Drug Application (NDA)

#NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

#Pharmaceutical Affairs Act(PAA)

#President's Council of Bioethics

#Priority Review

#protection of human research subjects

#Protection of Human Subjects

#Recombinant DNA Advisory Committee(RAC)

#regenerative medicine

#Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products

#Regulation of Stem Cell Research

#research with human subjects

#Risk Evaluation and Mitigation Strategy (REMS)

#Riskbasedapproach

#SCRO 절차

#SCRO Procedure

#Stem Cell Research

#Stem Cell Translational Research

#stem cell-based therapy