


Seohyung Lee Chief Attorney
“Socio jurídico sanitario con experiencia en regulación y gestión de riesgos”
Seohyung Lee, abogado de AI/Intelligence Group y Medical Bio Healthcare Group, proporciona un análisis tridimensional de cuestiones regulatorias, de cumplimiento y de disputas que surgen en diversas industrias y brinda asesoramiento estratégico que considera la intersección de la tecnología y la ley. Es un abogado regulatorio que ha presentado soluciones orientadas a la práctica en áreas que requieren tanto la utilización de datos como una respuesta regulatoria, especialmente en las industrias de atención médica, bio, atención médica digital y alta tecnología. En industrias basadas en tecnología, como la farmacéutica, los dispositivos médicos, la atención médica digital y los productos biofarmacéuticos avanzados, hemos analizado los riesgos regulatorios a lo largo de todo el proceso, desde la etapa de investigación y desarrollo hasta la concesión de licencias, los ensayos clínicos, el marketing, la publicidad y el uso de datos, y hemos diseñado un sistema de cumplimiento adecuado para la estructura de utilización de datos e inteligencia artificial. Además de abogado, tiene títulos de farmacéutico, abogado de patentes y doctor en derecho. También se ha desempeñado como investigador principal en el Instituto de Investigación de Derecho de la Universidad Nacional de Seúl y profesor de investigación en el Instituto de Investigación de Derecho Biomédico de la Universidad Ewha Womans, acumulando práctica regulatoria y experiencia en asesoramiento en diversas instituciones y sitios industriales. Nos enfocamos en brindar interpretación práctica y sistemas de asesoría orientados a estrategias para lograr los objetivos comerciales de nuestros clientes dentro del entorno regulatorio.
Experiencia
- (Former) Practical training at Yoon & Yang Law Firm, Inc.
- (Former) LK Partners Law Firm
- (Former) Senior Researcher, Law Research Institute, Seoul National University Law School
- (Former) Research Professor, Biomedical Law Research Institute, Ewha Womans University Law School
- (Former) Seung Law Firm
- (Current) Daeryun Law Firm (Limited)
Actividades Destacadas
- Advisor to the Ministry of Food and Drug Safety
- Member of the Ministry of Food and Drug Safety Administrative Disposition Review Committee
- Legislative Director, Academic Committee Member, Korean Medical Information Society
- Samsung Seoul Hospital Data Review Board (DRB) member
- Member of Institutional Bioethics Committee (IRB) at Seoul National University Bundang Hospital
- Hanyang University Guri Hospital Institutional Bioethics Committee (IRB) member, advisory member
- Advisory member of the Future Medical Research Foundation under the Ministry of Science and ICT
- Advisory member of the Korean Association of Medical Social Workers
- Legal advice to members of the Korean Neuropsychiatric Association
- Member of Korean Medical Law Society
- Member of the Korean Society of Bioethics
- Member of Korean Legal Philosophy Society
- Ministry of Health and Welfare, Ministry of Food and Drug Safety and affiliated public institutions, and related academic societies and associations invited to lecture at symposiums and academic conferences
- Contributions, books, and university lectures in the biomedical field
Logros Destacados
- Advice on research, development and marketing, including clinical trials (IRB and clinical trial plan approval, etc.) of drugs and medical devices, GMP, product approval, health insurance listing and drug price determination, adverse reaction reporting, labeling and advertising, etc.
- Advising on research and development of new medical technology products such as digital healthcare and advanced biopharmaceuticals, application for new medical technology evaluation, and marketing.
- Advised on practical work related to certification of innovative pharmaceutical companies and Ministry of Health and Welfare and Korea Health Industry Development Institute
- Litigation regarding administrative measures such as license suspension and business suspension of medical personnel and medical institutions
- Compliance advice on advertising regulations for medical institutions, pharmaceuticals, medical devices, etc.
- Litigation related to medical disputes between medical institutions and patients
- Compliance advisory and litigation related to rebates
- Advising on the establishment of medical corporations and overseas expansion of medical institutions
- Participating in revising laws on bioethics and safety, enacting the Advanced Regenerative Bio Act, and revising the “Health and Medical Data Utilization Guidelines”
- Legislative consulting on laws, notices, and guidelines such as the Pharmaceutical Affairs Act, Medical Services Act, Medical Device Act, Bioethics and Safety Act, Fair Trade Act, Advanced Regenerative Bio Act, Personal Information Protection Act, Cosmetics Act, and Food Sanitation Act.
- Advisory and litigation related to contracts with hospital management support companies (MSO)
- Evidence investigation and evidence preservation application case for compensation for urological medical accident damages
- Health Insurance Review and Assessment Service, lawsuit against Ministry of Health and Welfare's administrative disposition related to nursing care benefits
- Advice on data processing and privacy protection regulations
- Advised a large construction company on product liability.
- Advice on intellectual property rights, including technology licensing, patents, and trademark infringement
- Advisory and litigation regarding regulatory sandbox application by the Ministry of Science and ICT
Formación
- Graduated from Ewha Womans University College of Pharmacy, Department of Pharmaceutical Sciences (Bachelor of Pharmacy)
- Graduated from Ewha Womans University Law School (Master of Laws)
- Graduated from Ewha Womans University, Department of Law (Doctor of Laws)
Publicaciones y Artículos
- 『Law and Life of Koreans (Completely Revised Edition)』 (Ministry of Justice/Korean Legal Education Center, 2021)
- 『Law and Philosophy in the Corona Era』 (Parkyoungsa, 2021)
- 『Biomedical Ethics (Completely Revised 4th Edition)』 (Dongnyok, 2023)
- 『Health and Medical Informatics』 (Gunja Publishing, 2024)
- 『Criminal) Correctional Precedents』 (Parkyoungsa, 2024)
- “Duty of outpatient prescription medical institutions to return pharmaceutical expenses in relation to the comprehensive fee system - Focusing on the Supreme Court decision 2009du8786 pronounced on November 26, 2009 - ”, 「Bioethics Policy Research」 Vol. 5, No. 1 (2011).
- “Contemplation of the construction of domestic health care big data legislation - Focusing on the guarantee of the right to know -”, 「Medical Jurisprudence」 Vol. 19, No. 3 (2018).
- “Study on measures to improve anonymization under bioethics law”, Bioethics Vol. 20, No. 2 (2019).
- “Review of personal information protection legislation and direction of revision from the perspective of privacy protection - Focusing on the dichotomy between public and private sectors -”, 「Bioethics Policy Research」 Vol. 13, No. 2 (2020), etc.
Certificaciones
- Attorney
- Pharmacist
- Patent Attorney
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