張宇淳
Senior Advisor概要
Mr. Woo-Soon Jang is a Senior Advisor at Shin & Kim, and provides advisory services on drug reimbursement pricing in the pharmaceutical and bio industries and compliance.
Mr. Jang has performed major policy-related duties for relevant industries at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association, including those related to drug reimbursement pricing, compliance, external cooperation, global business affairs, AI-driven drug development and the fostering of talented manpower, conducting policy coordination between the industry and the government.
In particular, Mr. Jang has performed practical duties with respect to changes in the regulatory environment of the pharmaceutical industry, including overhauls of the drug reimbursement pricing system, responses to the introduction of the dual punishment system and two-out system, and the operation of the administrative surcharge system for rebates. He has also performed duties relating to the amendment of the Fair Competition Code, overhaul of corporate codes of ethics and by-laws, introduction of the compliance management system, etc. for the establishment of compliance systems for pharmaceutical companies
Based on such substantial experience as above, Mr. Jang currently provides his clients with advisory services on regulatory responses and the establishment of policies and strategies for the pharmaceutical/bio industries.
関連業務内容
経歴
- 2026-PresentShin & Kim LLC
- 2024-2025President, Pharmaceutical Bio Academy, Korea Pharmaceutical and Bio-Pharma Manufacturers Association(KPBMA); Head, Task Force for Promotion of Project for Commemoration of 80th Anniversary of Incorporation
- 2022-2023Head, Research Department, Executive Director, AI Institute for Drug Development, KPBMA
- 2020-2022Head, External Cooperation Department, Executive Director, KPBMA (in charge of drug reimbursement pricing, fair competition and global cooperation)
- 2014-2020Director General, Insurance Policy Bureau, KPBMA (in charge of drug reimbursement pricing, distribution, fair competition and compliance)
- 2006-2014Head, Drug Distribution and Pricing Team and Public Relations and Planning Team, KPBMA
主な実績
Pharmaceutical and Biotechnology Policy
- Advised on strategies to respond to proposed reforms to the National Health Insurance drug pricing system, including preparation of a comprehensive opinion letter and regulatory review (November 28, 2025)
- Advised Pharmaceutical Company A on the reassessment of prices for existing listed drugs in connection with reforms to the drug pricing system, including applicable eligibility criteria
- Advised Pharmaceutical Company B on reasonable pricing and distribution costs for essential drugs at risk of supply discontinuation
- Advised Pharmaceutical Company C on strategies for utilizing the Flexible Pricing Agreement (FPA)
Reimbursement Listing and Management of Pharmaceutical Products
- Advised Pharmaceutical Company AA on obtaining National Health Insurance reimbursement listing for its new drug, aa
- Advised Pharmaceutical Company BB on price negotiations for its drug bb under the Price-Volume Agreement (PVA)
- Advised Pharmaceutical Company CC on an application for a price adjustment for its drug cc
- Advised Pharmaceutical Company DD on the reassessment of reimbursement appropriateness for its drug dd
Compliance
- Advised Pharmaceutical Company AAA and others on certification and recertification as Innovative Pharmaceutical Companies
- Provided legal advice to Pharmaceutical Company BBB and others on improvements to the Innovative Pharmaceutical Company Certification System
- Advised Pharmaceutical Company CCC and others on responding to media issues concerning clinical reassessments
学歴
- 1987-1993Incheon National University, Department of English Language and Literature (B.A.)
言語
Korean, English