Shihang Lee

Overview

Shihang Lee focuses on the Healthcare & Life Sciences industry, and his practice areas cover Corporate, Regulatory, and Intellectual Properties.

Based on his scientific background as well as experience of serving the regulatory authority, Mr. Lee provides in-depth legal advice for both domestic and international clients in the healthcare sector, including biotech, digital health, food, cosmetics, and pet care. Shihang has gained profound experience in legal issues that are unique to the healthcare industry, including tech transfer, clinical trial, health data privacy, start-up investment, and distributorship.

Mr. Lee received his B.S. from University of California, Berkeley, and was seconded to the Ministry of Food and Drug Safety while serving as judge advocate for public service, Ministry of Justice. Shihang has consulted various start-up companies before joining in Bae, Kim & Lee LLC. Further, he advocates the rights of persons with mental disabilities.

Related Practices

Representative Experience

2021-Present 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)

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

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

Representative Matters

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)

Education

2016 Yonsei University Law School (J.D.)

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

Qualifications

2016 Korea