Professional Summary
Ryosuke Tateishi is a Partner of the Tokyo Corporate/M&A and Dispute Resolution groups. Prior to joining Baker McKenzie, Ryosuke worked for Sumitomo Corporation. He is a member of the Daini Tokyo Bar Association and has been a METI-registered management consultant since 2003.
Practice Focus
Ryosuke focuses his practice on general corporate law matters, and specializes in assisting domestic and overseas companies in health care-related industries — including the pharmaceutical, medical device and food industries — with compliance under the Pharmaceutical and Medical Devices Act, the Food Hygiene Act, the Food Labelling Act, the Anti-monopoly Act and the Act against Unjustifiable Premiums and Misleading Representations, among others. Ryosuke also provides anti-bribery policy compliance assistance.
Representative Clients, Cases or Matters
- Assisted a multinational pharmaceutical company in connection with supply of COVID19-related products to Japan.
- Assisted a US biopharmaceutical company in collaboration project for development and commercialization of Alzheimer-related products.
- Assisted a regenerative medical products manufacturer in establishing and implementing compliance program.
- Provided legal and compliance support for companies developing robotic technologies in healthcare industry.
- Provided legal and compliance support for technology companies and medical device companies in connection with development and supply of wearable devices and relevant healthcare software.
- Assisted a US medical device manufacturer with dispute resolution, crisis management, internal investigation and compliance, including anti-bribery policy compliance.
- Assisted a UK pharmaceutical company in establishing a compliance program concerning off-label information disclosure.
- Assisted a US pharmaceutical company in establishing a compliance program concerning advertising, including disease awareness activities.
- Assisted a US pharmaceutical company in conducting a “deep dive” compliance audit.
- Provided legal advice and assisted a number of pharmaceutical companies and medical device companies in license agreements and collaboration transactions.
- Provided legal supports for pharmaceutical companies in research and development projects performed in collaboration with Japanese academic institutions.
- Provided legal advice to a US medical device company regarding a product liability dispute.
- Provided legal advice to pharmaceutical companies and medical device companies regarding compliance with the Clinical Research Act.
- Assisted a number of pharmaceutical companies in reviewing promotional materials and provided instruction and advice about the implementation of sales information provision activities as an external member of the Pharmaceutical Company Review and Supervisory Committee.
- Provided legal advices for OTC drug companies and food companies in connection with compliance with Act against Unjustifiable Premiums and Misleading Representations.
- Provided legal advices for pharmaceutical companies in connection with authorized generic projects from perspective of competition law.
- Assisted a domestic energy company, an electrical appliance company and a trading house in establishing anti-bribery policy compliance programs and provided anti-bribery training.
- Represented an investment company and a bank in litigation concerning derivative products.
- Represented a domestic wholesale company in establishing a joint venture company in Vietnam.
- Represented a Japanese illumination company in establishing a joint venture company in Japan.
- Assisted a Japanese company in litigation in the Middle East region concerning the termination of a distributorship.
- Assisted toy, sporting goods and food manufacturers with product recalls and with the handling of related mass media announcements.
Publications, Presentations and Articles
- Co-author, “Strategic Legal Considerations for the Development of AI-Based Medical and Healthcare Products and Services”, Research and Development Leader, Technical Information Institute Co., Ltd., October 2024, Language: Japanese
- Author, “Japan’s regulatory requirements for Software as a Medical Device (SaMD)”, Journal of Medical Device Regulation, Global Regulatory Press, May 2024
- Speaker, “Practice of Global Compliance”, Presentation, Compliance Research Group of the Japan Pharmaceutical Industry Legal Affairs Association, December 2023
- Author, “Clinical Trials: Overview (Japan) “, Thomson Reuters Practical Law, Thomson Reuters, November 2023
- Author, “Legal issues arising out of treatment of PHR (Personal Health Record)”, PHARMSTAGE, Technical Information Institute Co., Ltd., February 2023, Language: Japanese
- Speaker, “Consideration about treatment of Software as Medical Device and legal advice for resolving obstacles”, Presentation, Science & Technology Co.,Ltd., December 2022
- Speaker, “Major compliance issues in pharmaceutical industry”, Presentation, Japanese Institute for Public Engagement, November 2022
- Co-author, “Key legal issues for starting business in digital health market” – “Digital Health in 5G Era” Technical Information Institute Co., Ltd., September 2022, Language: Japanese
- Speaker, “Assessment as to whether healthcare software is treated as medical device (SaMD) and strategy for responding to regulations under the Pharmaceutical and Medical Devices Act and the Act against Unjustifiable Premiums and Misleading Representations”, Presentation, Science & Technology Co.,Ltd., May 2022
- Speaker, “Legal considerations for commercializing digital health products”, Presentation, Johokiko Co., Ltd., February 2022
- Author, “Legal Mind November 2021” Japan Pharmaceutical Industry Legal Affairs Association Journal, November 2021
- Speaker, “Legal considerations for commercializing digital health products” Japan Pharmaceutical Industry Legal Affairs Association monthly meeting, September 2021
- Co-author, “Product Liability Issues for Companies Supplying Medical Supplies during COVID-19 crisis: Overview of European and US Legislation” Chuokeizai-sha (Emergency Information Website), May 2020, Language: Japanese
- Author, “Impact of “Guidelines about Sales Information Provision Activities” on pharmaceutical companies”, PHARMSTAGE, Technical Information Institute Co., Ltd., April 2020
- Co-author “Explanation about Foreign Bribery Guidance”, Monthly Audit, Japan Audit & Supervisory Board Members Association, No. 663, February 2017
- Co-author, “Trends in enforcement by authorities in the US, UK and China and necessary compliance procedures,” Business Law Journal, LexisNexis, November 2015
- Co-author, “World Legal & Business Guide No. 12 Philippines,” Business Law Journal, LexisNexis, March 2012
- Co-author, “Legal and tax practices for conducting business in Asia – from business start-up to expansion and withdrawal,” Chuokeizai-sha, August 2011, Language: Japanese
- Co-author, “UK Bribery Act,” Business Law Journal, LexisNexis, August 2011
Admissions
- New York, United States (2015)
- Japan (2008)
Professional Association and Memberships
- Daini Tokyo Bar Association
- New York State Bar Association
- American Bar Association
Education
- University of California Los Angeles (LLM) (2014)
- Waseda University (JD) (2007)
- The University of Tokyo (LLB) (1998)
Languages
Japanese
English