2025-04-03T06:02:30Z

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씨엔알리서치는 3일, 식품의약품안전처 출신의 통계 전문가 정지원 박사를 영입하여 국내 및 글로벌 맞춤형 컨설팅 역량을 강화한다고 밝혔다. 정지원 박사는 씨엔알리서치 정보본부(Data Solution Headquarter) 산하 BS(Biostatistics) advisor로서, 신약 개발 계획 및 전략 수립에 관한 맞춤형 컨설팅 업무를 담당할 예정이다. 정 박사는 국내 굴지의 제약사에서 임상통계학자로 근무한 경험과 식약처에서 쌓은 풍부한 경험을 바탕으로, 국내 IND/NDA 허가를 위한 식약처의 요구 사항에 대한 깊은 이해를 갖추고 있다. 정 박사는 식약처 재직 당시 550건 이상의 IND(Investigational New Drug), 320건의 NDA(New Drug Application), 150건의 생동(생물학적 동등성) 심사를 경험했으며, 다수의 의료기기 IND/NDA 과정에 관여한 바 있다. 또한 기관, 의뢰사, CRO의 실사 업무를 다수 수행한 경험도 보유하고 있다. 씨엔알리서치 관계자는 “글로벌 제약 시장에서 신약 개발과 맞춤형 의약품 수요가 증가함에 따라 정교한 임상시험 설계와 효율적인 허가 절차의 필요성이 커지고 있다”며, “당사 정보본부는 BS division, MO(Medical Operation) division, DM(Data Management) division, RWO(Real World Operation) division 등 4개의 조직으로 구성되어 있으며, 각 조직은 글로벌 CRO를 지향하는 회사의 방향성에 맞춰 각 업무 영역별 전 과정을 해외 규제 기관의 요청 사항에 부합하도록 업무 절차를 수립하여 고객 맞춤형 통합 서비스를 제공하고 있다”고 말했다. 이어 “이번 정지원 박사 영입을 통해 빠르게 변화하는 시장에 능동적으로 대응하고, 인허가 관련 컨설팅 역량을 강화하여 글로벌 CRO로 성장해 나가는 데 중요한 발판을 마련할 것으로 기대된다”고 덧붙였다. Like this: Like Loading... Related CNR Research hires Dr. Jiwon Jeong, a former Food and Drug Administration inspector On the 3rd, CNR Research announced that it will strengthen its domestic and global customized consulting capabilities by hiring Dr. Jiwon Jeong, a statistics expert from the Ministry of Food and Drug Safety. Dr. Jeong Ji-won will be in charge of customized consulting services on new drug development plans and strategy establishment as a BS (Biostatistics) advisor under the Data Solution Headquarters of CNR Research. Based on his experience as a clinical statistician at a leading domestic pharmaceutical company and his extensive experience at the Ministry of Food and Drug Safety, Dr. Jeong has a deep understanding of the requirements of the Ministry of Food and Drug Safety for domestic IND/NDA approval. During his tenure at the Ministry of Food and Drug Safety, Dr. Jeong experienced over 550 IND (Investigational New Drug), 320 NDA (New Drug Application), and 150 bioequivalence (bioequivalence) reviews, and was involved in numerous medical device IND/NDA processes. He also has extensive experience performing inspections for institutions, clients, and CROs. An official from C&R Research said, “As the demand for new drug development and personalized medicine increases in the global pharmaceutical market, the need for sophisticated clinical trial design and efficient approval procedures is growing,” and added, “Our information headquarters is comprised of four organizations: the BS division, MO (Medical Operation) division, DM (Data Management) division, and RWO (Real World Operation) division. In line with the direction of the company toward becoming a global CRO, each organization establishes work procedures for each business area to meet the requests of overseas regulatory agencies, thereby providing customized integrated services to customers.” He added, “We expect that the recruitment of Dr. Jeong Ji-won will provide an important foundation for our growth as a global CRO by proactively responding to the rapidly changing market and strengthening our consulting capabilities related to licensing.” CNR Research 聘请前食品药品管理局检查员 Jiwon Jeong 博士 CNR Research 3日宣布，将聘请韩国食品药品安全部统计学专家Jiwon Jeong博士，加强其国内和全球定制咨询能力。 郑智源博士将担任 CNR Research 数据解决方案总部的 BS（生物统计学）顾问，负责提供与新药开发计划和战略制定相关的定制咨询服务。凭借在国内领先药企担任临床统计师的经历，以及在食品药品安全部积累的丰富经验，郑博士对食品药品安全部对于国内IND/NDA审批的要求有着深入的理解。 在食品药品安全部任职期间，郑博士经历了超过 550 项新药研究 (IND)、320 项新药申请 (NDA) 和 150 项生物等效性 (bioequivalence) 审查，并参与了许多医疗器械 IND/NDA 流程。他还拥有为机构、客户和 CRO 执行尽职调查工作的丰富经验。 C&R Research 的一位官员表示：“随着全球医药市场对新药开发和个性化医疗的需求不断增长，对精密临床试验设计和高效审批程序的需求也日益增长”，并补充道：“我们的信息总部由四个组织组成：BS 部门、MO（医疗运营）部门、DM（数据管理）部门和 RWO（真实世界运营）部门。为了配合公司成为全球 CRO 的方向，每个组织都针对每个业务领域制定了工作流程，以满足海外监管机构的要求，从而为客户提供定制的综合服务。” 他补充道：“我们期待，郑智源博士的加盟将为我们作为全球CRO的成长奠定重要基础，让我们能够积极应对快速变化的市场，并加强与许可相关的咨询能力。” CNR Research embauche le Dr Jiwon Jeong, un ancien inspecteur de la Food and Drug Administration Le 3, CNR Research a annoncé qu'elle renforcerait ses capacités de conseil personnalisées nationales et mondiales en embauchant le Dr Jiwon Jeong, un expert en statistiques du ministère de la Sécurité alimentaire et pharmaceutique. Le Dr Jeong Ji-won occupera le poste de conseiller BS (biostatistique) au sein du siège de Data Solution de CNR Research, où il sera chargé de fournir des services de conseil personnalisés liés aux plans de développement de nouveaux médicaments et à la formulation de stratégies. Fort de son expérience en tant que statisticien clinique dans une importante société pharmaceutique nationale et de sa vaste expérience au ministère de la Sécurité alimentaire et des médicaments, le Dr Jeong possède une connaissance approfondie des exigences du ministère de la Sécurité alimentaire et des médicaments en matière d'approbation IND/NDA nationale. Au cours de son mandat au ministère de la Sécurité alimentaire et pharmaceutique, le Dr Jeong a participé à plus de 550 demandes d'autorisation de mise sur le marché de nouveaux médicaments (IND), 320 demandes d'autorisation de mise sur le marché de nouveaux médicaments (NDA) et 150 examens de bioéquivalence (bioéquivalence), et a été impliqué dans de nombreux processus d'autorisation de mise sur le marché (IND/NDA) de dispositifs médicaux. Il possède également une vaste expérience dans la réalisation de travaux de diligence raisonnable pour des institutions, des clients et des CRO. Un responsable de C&R Research a déclaré : « Face à la demande croissante de développement de nouveaux médicaments et de médecine personnalisée sur le marché pharmaceutique mondial, le besoin de conceptions d'essais cliniques sophistiquées et de procédures d'approbation efficaces s'accroît. » Il a ajouté : « Notre siège social informatique se compose de quatre entités : la division BS, la division MO (Opérations médicales), la division DM (Gestion des données) et la division RWO (Opérations en conditions réelles). Conformément à la volonté de l'entreprise de devenir une CRO mondiale, chaque entité établit des procédures de travail pour chaque secteur d'activité afin de répondre aux demandes des agences réglementaires internationales, offrant ainsi des services intégrés et personnalisés à ses clients. » Il a ajouté : « Nous espérons que le recrutement du Dr Jeong Ji-won constituera une base importante pour notre croissance en tant que CRO mondial en répondant de manière proactive à l'évolution rapide du marché et en renforçant nos capacités de conseil liées aux licences. » Like this: Like Loading...