李時沆

概要

Shihang Lee is an attorney with strengths in the healthcare sector, specializing in healthcare data, pharmaceutical and medical regulations, and biotech consulting.

Mr. Lee provides advisory services for government projects related to healthcare data and for regulatory sandboxes, contributing to the establishment of regulatory interpretation precedents in areas where the Medical Services Act, the Bioethics and Safety Act, and the Personal Information Protection Act interact.

Based on his experience in the Ministry of Food and Drug Safety, Mr. Lee advises on overall regulatory compliance and administrative and criminal procedures related to licensing, quality assurance, clinical trials, and expenditure report preparation for pharmaceuticals, medical devices, cosmetics, food, and health functional foods.

Additionally, utilizing his knowledge in biotechnology and his network in the startup industry, Mr. Lee effectively analyzes the regulatory risks of new business models and pipelines to support the establishment of investment and growth strategies.

Related Practices

経歴

2021-現在 Bae, Kim & Lee LLC

2019-2021 D'LIGHT Law Group

2016-2019 Judge Advocate for Public Service, Ministry of Justice

2016-2017 Ministry of Food and Drug Safety (Secondment)

その他経歴

2024-現在 Ombudsman, Ministry of Food and Drug Safety

2021-現在 Member, Healthcare Data Review Specialist Group, Korea Health Information Service

2019-2020 External Committee Member, Institutional Bioethics Committee, Ajou University Hospital

主な案件実績

Advised K-HIS on its discussion on the amendment of the MoHW Notice of the Bio-health Data Terminology and Transmission Standard

Advised KPBMA on its development of a curriculum for training pharmaceutical workers on how to obtain an MR certificate

Advised a number of pharmaceutical/medical device companies on their distribution-related activities (concerning, e.g., expenditure reports, post-marketing surveys, and second-hand products) and labelling/advertising activities (concerning, e.g., websites, and marketing materials)

Advised food/health functional food/cosmetics companies on their product labelling-related matters

Advised Company A on its responses to the investigation into its alleged GMP violation, representing it in the resulting litigation

Advised K-HIS on its discussion on the amendment of the MoHW Notice of the Bio-health Data Terminology and Transmission Standard

Advised KPBMA on its development of a curriculum for training pharmaceutical workers on how to obtain an MR certificate

Advised a number of pharmaceutical/medical device companies on their distribution-related activities (concerning, e.g., expenditure reports, post-marketing surveys, and second-hand products) and labelling/advertising activities (concerning, e.g., websites, and marketing materials)

Advised food/health functional food/cosmetics companies on their product labelling-related matters

Advised Company A on its responses to the investigation into its alleged GMP violation, representing it in the resulting litigation

Advised Company B on its responses to and litigation on the dispute over the termination of the concerned license agreement

Advised Company C, a multinational fashion company, on the project for ensuring its Korean branch to achieve privacy-law compliance in Korea

Provided a number of pharmaceutical/medical device/tech/insurance companies with legal review services regarding their health data-processing systems while advising them on how to prepare related contracts and consent forms and all other necessary documents

Advised Korean/foreign strategic/financial investors on their pre-IPO investments in Korean bio-venture companies

Advised Company D on its ESG project (to be specific, on its anti-corruption and social contribution activities)

Advised clients on their compliance works under the COVID-19 pandemic situation (related to, e.g., HR and service provision)

学歴

2016 Yonsei University Law School (J.D.)

2011 University of California, Berkeley (B.S.)

資格

2016 Korea

概要

Related Practices

経歴

主な案件実績

学歴

資格

取扱業務分野

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