سيوهيونغ لي Chief Attorney | شركة داريون للمحاماة - الخبراء والمحامون الموصى بهم

سيوهيونغ لي

Chief Attorney

مستشار وزارة الغذاء والسلامة الدوائية

T. 070-7510-2016

سيوهيونغ لي

Chief Attorney

مستشار وزارة الغذاء والسلامة الدوائية

T. 070-7510-2016

"شريك قانوني في مجال الرعاية الصحية يتمتع بخبرة في التنظيم وإدارة المخاطر"

يقدم سيوهيونغ لي، المحامي في AI/Intelligence Group وMedical Bio Healthcare Group، تحليلاً ثلاثي الأبعاد للقضايا التنظيمية والامتثال والنزاعات التي تنشأ عبر مختلف الصناعات ويقدم المشورة الإستراتيجية التي تأخذ في الاعتبار تقاطع التكنولوجيا والقانون. وهو محامٍ تنظيمي قدم حلولاً عملية في المجالات التي تتطلب استخدام البيانات والاستجابة التنظيمية، خاصة في مجالات الرعاية الصحية والرعاية الصحية الحيوية والرقمية وصناعات التكنولوجيا المتقدمة. في الصناعات القائمة على التكنولوجيا مثل الأدوية والأجهزة الطبية والرعاية الصحية الرقمية والمستحضرات الصيدلانية الحيوية المتقدمة، قمنا بتحليل المخاطر التنظيمية طوال العملية بأكملها بدءًا من مرحلة البحث والتطوير وحتى الترخيص والتجارب السريرية والتسويق والإعلان واستخدام البيانات، وقمنا بتصميم نظام امتثال مناسب لبنية الذكاء الاصطناعي واستخدام البيانات. بالإضافة إلى كونه محاميًا، فهو يحمل مؤهلات صيدلي ومحامي براءات اختراع ودكتوراه في القانون. وقد عمل أيضًا كباحث أول في معهد أبحاث القانون بجامعة سيول الوطنية وأستاذ باحث في معهد أبحاث القانون الطبي الحيوي بجامعة Ewha Womans، حيث قام بتجميع الممارسات التنظيمية والخبرة الاستشارية في مختلف المؤسسات والمواقع الصناعية. نحن نركز على تقديم تفسير عملي وأنظمة استشارية موجهة نحو الإستراتيجية لتحقيق أهداف أعمال عملائنا ضمن البيئة التنظيمية.

مجالات الممارسة ذات الصلة

الخبرة

(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)

الأنشطة الرئيسية

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

الإنجازات الرئيسية

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

المؤهلات العلمية

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)

المؤلفات والأبحاث

『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.