概要
Hyojun An is a partner of Bae, Kim & Lee LLC, who has remarkable expertise in the area of healthcare regulations compliance/anti-corruption/government relations. Based on her rich experience in the industry, Ms. An advises healthcare companies and multinational companies government's investigations and administrative measures, defenses in criminal cases, applicable regulations, GR, litigations, and deals.
Ms. An has extensive experience, particularly in the corporate compliance audit and internal investigation, and has served as a qualified certified auditor for ISO 37001 (Anti-bribery Management System) at the International Organization for Standardization (ISO). Before joining BKL, she worked at the Korean Research-based Pharma Industry Association, handling a wide range of tasks from operating and revising the Fair Competition Code of the pharmaceutical industry to responding to the government with respect to healthcare laws and regulations and related notifications. Currently, she is a member of the Institutional Review Board of the Korea University Guro Hospital and a member of the Medical Devices Advertisement Pre-review Board of the Korea Medical Devices Industry Association.
Related Practices
経歴
2014-現在
Bae, Kim & Lee LLC
2011-2014
Attorney, Ethics and Compliance Department, Korean Research-based Pharma Industry Association
2010-2011
Attorney, TY & Partners
その他経歴
2023-2024
Member, Pharmaceuticals Advertisement Pre-review Board, Korea Pharmaceutical and Bio-Pharma Manufacturers Association
2022-現在
Member, In Vitro Diagnostic Medical Device Expert Committee, Ministry of Food and Drug Safety
2021-2023
Member, Practical Committee for the Fostering and Supporting of the Pharmaceutical Industry, Ministry of Health and Welfare
2021-2022
Member, Pharmaceuticals Advertisement Pre-review Board, Korea Pharmaceutical and Bio-Pharma Manufacturers Association
2020-現在
Member (Legal Advisor), Chief Compliance Officers' Committee, Korea Pharmaceutical and Bio-Pharma Manufacturers Association
2020-2022
Member, Medical Devices Advertisement Pre-review Board, Korea Medical Devices Industry Association
2018-2024
Qualified Certified Auditor for ISO 37001 (Anti-bribery Management System), International Organization for Standardization
2015-2020
Member, Institutional Review Board, Korea University Guro Hospital
主な案件実績
Successfully defended multinational/domestic medical device and pharmaceutical companies against government agency-led investigations, administrative measures, and criminal cases for provision of improper economic benefits
Advised numerous multinational/domestic companies on establishing internal regulations, performing a compliance audit, and conducting an internal investigation in relation to the applicable laws, such as Korean anti-corruption law, pharmaceutical law, privacy and data protection law
Advised multinational/domestic companies on the legislation of health and medical laws and responding to the National Assembly
Advised multinational/domestic companies on digital health, healthcare data, and data privacy
Advised healthcare companies on product indication (labeling)∙advertisement∙product launch
Successfully defended multinational/domestic medical device and pharmaceutical companies against government agency-led investigations, administrative measures, and criminal cases for provision of improper economic benefits
Advised numerous multinational/domestic companies on establishing internal regulations, performing a compliance audit, and conducting an internal investigation in relation to the applicable laws, such as Korean anti-corruption law, pharmaceutical law, privacy and data protection law
Advised multinational/domestic companies on the legislation of health and medical laws and responding to the National Assembly
Advised multinational/domestic companies on digital health, healthcare data, and data privacy
Advised healthcare companies on product indication (labeling)∙advertisement∙product launch
Represented multinational pharmaceutical and medical device companies in disputes with local distributors and agents over, among others, termination of agreements, product registration transfers, intellectual property infringement, violation of non-competition agreements
Successfully defended a multinational cosmetics and hygiene products-importing company against consumers' grievances and complaints and product recalls
Advised a global cosmetics-importing company on how to address its violation of the Korean Public Health Control Act
Advised a foreign medical device company on its violation of the customs clearance procedure
Advised a Japan-affiliated pharmaceutical company on its internal audit
Advised, and provided training services to, Korean conglomerates and multinational companies on the Korean Improper Solicitation and Graft Act
学歴
2009
Judicial Research and Training Institute, Supreme Court of Korea
2007
Korea University (LL.B.)
主な活動
著述
Legislation of CP under the Fair Trade Act and its implications on the pharmaceutical industry, KPBMA FOCUS Vol. 13 (Korea Pharmaceutical & Pharma Manufacturers Association, 2024)
Global Ethical Management Trends and Implications - Shift from Simple Regulation to Incentivizing, KPBMA FOCUS Vol. 25 (Korea Pharmaceutical & Pharma Manufacturers Association, 2023)
Getting the Deal Through: Digital Health - South Korea (Lexology, 2021-2023)
Issues and Practices of Compliance in Healthcare - Kickbacks in the Pharmaceutical and Medical Device Fields, BFL No. 113 (Seoul National University Center for Financial Law, 2022)
Ethical management trends in the European pharmaceutical industry, 2022 KPBMA Pharmaceutical bio industry Ethical Management Report (Korea Pharmaceutical and Bio-Pharma Manufacturers Association, 2022)
Suggestions for Improving the KRPIA Code of Conduct and Comparison with the Code of the IFPMA Member Associations, Korean Journal of Medical Ethics, Vol.18, No.4 (Korean Society for Medical Ethics, 2015)
活動
Speaker, Types of Clinical Trials and How to Prepare Expenditure Report (Compliance Academy of Pharmaceutical Industry co-hosted by the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA) and Korean Research-based Pharmaceutical Industry Association (KRPIA), 2023)
Speaker, Sunshine act case studies (Conference of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 2022)
Panelist, LPD Showcase: 2020 - the Year of the Whistleblower (Conference of the International Bar Association (IBA), 2020)
Panelist, Global Anti-Corruption Update (Conference of the International Bar Association (IBA), 2019)
Speaker, Fair Trade Enforcement in Pharmaceutical Industry (Conference of Korean Research-based Pharma Industry Association (KRPIA), 2019)
Speaker, Management of Third-party for Pharmaceutical Companies (Conference of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 2019)
Speaker, Analysis on Recent Illegal Kickback Cases (Conference of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 2019)
Speaker, Regulation on Marketing for Digital Devices (Conference of the Korea Medical Devices Industry Association (KMDIA), 2019)
Speaker, Update on Global Ethical Practice-Revised IFPMA Code and WSMI Guideline (Conference of the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), 2018)
資格
2009
Korea
