Ayuko Nemoto

Japan (2007)

Dai-ni Tokyo Bar Association

New York State Bar Association

Observer of the International Affairs Working Group of Japan Pharmaceutical Industry Legal Affairs Association (since April 2017)

MA & Clinical Trial Working Group of Japan Pharmaceutical Industry Legal Affairs Association (since April 2018)

Supporter of Medical Innovation Support Office of Ministry of Health, Labour and Welfare (MEDISO) (since April 2018)

Ethics committee of the Council for Industrial use of Biological and Environmental Repositories (CIBER)(since July 2019)

Steering committee of the Council for Industrial use of Biological and Environmental Repositories (CIBER)(since April 2020)

Ethics committee of GENEX, Inc. (January 2021 – December 2022)

Mentor of Blockbuster TOKYO (since June 2021)

Femtech Community Japan Advisor (since July 2021, Incorporation as a General Incorporated Association in August 2022)

Observer of Healthcare Innovation Hub (InnoHub) (since August 2021)

GENEX Inc., Member, Association of Genetic Information (since April 2020)

In-house Clinical Trial Review Committee Member of intellim Corporation (since December 2022)

“Is it possible to treat patients in the Metaverse? ” (Yakuji Nippo) January 23, 2023

“Overview of FemTech and Related Laws and Regulations” (Business Law Review, September 2022) July 2022.

“FEMTECH Regulations – Insurance Coverage of Fertility Treatment and How Companies Treat Employees Undergoing Fertility Treatment” (S&E Newsletter), May 2022.

“SDGs, Intellectual Property Strategies to Attract ESG Investments from the Perspective of the Global Situation on ESG” (Business Law Review, May), March 2022

“Draft Guidelines on Disclosure and Governance of Strategies for Investment and Use of Intellectual Property and Intangible Assets ”(S&E Newsletter), January 2022

“FEMTECH Regulations – Perspectives on the Evaluation of Trans-dermal Absorption Panties, etc. and Perspectives on Advertising Expression Pertaining to Trans-dermal Absorption Panties, etc.” (S&E Newsletter) October 25, 2021

“The Position of Intellectual Property in the Corporate Governance Code and the Revised Guidelines for Investor-Company Dialogue and its Response” (S&E Newsletter), July 16, 2021

“Revision of the PMD Act (Pharmaceutical and Medical Device Act) -Establishment of Guidelines for Compliance by Sellers, Lessors and Repairers of Medical Devices and Guidelines for Compliance by Pharmacy Establishers and Sellers of Pharmaceuticals” (S&E Newsletter), June 30, 2021

“Establishment of Ethical Guidelines for Life Science and Medical Research Involving Human Subjects and Responses” (S&E Newsletter), April 12, 2021

“Establishment of Ethical Guidelines for Life Science and Medical Research Involving Human Subjects and Responses” (Yakuji Nippo) April 30, 2021

“The revised Pharmaceuticals and Medical Devices Act of 2019-Promulgation of Revised Ministerial Ordinance (Revised Ordinance for Enforcement of the PMD Act), Including Revisions Related to Legal Compliance Systems” (S&E Newsletter), February 8, 2021.

“The revised Pharmaceuticals and Medical Devices Act of 2019-Promulgation of Revised Ministerial Ordinance (Revised Ordinance for Enforcement of the PMD Act), Including Revisions Related to Legal Compliance Systems” (Yakuji Nippou), February 2021

“Outline of Draft Guidelines for Establishment of Legal Compliance System, etc. Required under the Revision of the PMD Act (Pharmaceutical and Medical Device Act)” (Lexis Nexis Japan, Business Law Journal 2020/11), September 2020

“Revision of the PMD Act (Pharmaceutical and Medical Device Act) – Publication of Draft Guidelines for Compliance by Manufacturers and Distributors (Volume 1,2,3)” (Yakuji nippo) September 2, 4, 9, 2020

“Revision of the PMD Act (Pharmaceutical and Medical Device Act) – Publication of Draft Guidelines for Compliance by Manufacturers and Distributors” (S&E Newsletter), August 17, 2020

“Revision of the PMD Act (Pharmaceutical and Medical Device Act) and Its Impact on Companies” (Lexis Nexis Japan, Business Law Journal 2020/5), March 24, 2020

“2019 proposal for revision of the PMD Act (Pharmaceutical and Medical Device Act) and its impact on businesses” (S&E newsletter) November 28, 2019

“2019 proposal for revision of the PMD Act (Pharmaceutical and Medical Device Act) and its impact on businesses” (Yakuji Nippo) December 6, 2019

“Learning about Industry-specific Law Practices through Q & A: Medicine and Medical Devices” (Chuo Keizai Holdings, collaboration with Ryugo Iwamoto et al.) 2019

“Workplace Harassment Comes in Many Forms:  How Can You Help Your Company Prevent and Deal with Harassment in the Workplace” (Lexis Nexis Japan Lawyers Guide, 2019/20) 2019

“Workplace Harassment Comes in Many Forms: How Can You Help Your Company Prevent and Deal with Harassment in the Workplace” (S&E Newsletter) August, 2018

“The Contractual Provisions Needed to Deal with Brexit – From the Perspective of Japanese Companies”（ (No. 1079 of NBL, August 1, 2016, Co-author: Naoki Watanabe）

“Market Trend of M&A Provisions for US Non-Public Companies” (No. 1022-24, 1026-28 of NBL, April through July 2014, Co-Author: Naoki Watanabe)

“Case Studies for Financial Instruments and Exchange Law” (2009 published by Jiyu-Kokumin-Sha)

“Learning from Our Predecessors: Medical Device Programs and Regulations” (2-Day Symposium for medical ventures and academia who need to take a step forward: riding the Ecosystem wave, sponsored by the Japanese Ministry of Health, Labor and Welfare) , February 3, 2023

“Femtec and the Law: Relevant Laws and Regulations to Keep in Mind” (First Certified Femtec Senior Expert Course of the Japan Femtec Association) November 15, 2022 – January 10, 2023

“Key Legal and Compliance Practices for Femtec Product Services” (Femtec Promotion EXPO Vol. 2) – from September 12, 2022 onward

“Harassment in times of Digital Work Environments” (German Chamber of Commerce in Japan), September 27, 2022

“Information on the admission procedure and market entry conditions” (guest speaker at the German-Japanese Biomedical Technology Forum organized by the German Chamber of Commerce in Japan), July 19, 2022.

“Digital Health and the Japanese Legislation You Need to Know,” (Governance & Legal Committee of the European Federation of Pharmaceutical Industries and AssociationsEFPIA Japan), April 25, 2022

“Harassment in the Workplace and Legal Liability in Japan” (guest speaker for the Master of Law (LL.M.) Professional Degree Program in Global Legal Studies, Keio University Graduate School of Law, January 2022)

“Biomedical Personal Information Protection Regulation Seminar–For Safe and Secure Use of Biomedical Samples and Data–Part 3 (applied session) , Precautions for Primary Use, Secondary Use, and Overseas Transfer of Biomedical Samples and Data” (CIBER (Council for Industrial Use of Biological and Environment Repositories)), January 13, 2022

“Overcoming the regulatory hurdle of medical data use and digital healthcare Current issues in Japan and differences from US and UK”（PISTOIA ALLIANCE – GLOBAL KNOWLEDGE-SHARING: EMERGING SCIENCE & TECHNOLOGY IN JAPAN LIFE SCIENCES）Dec. 9, 2021

“Latest News! Important Points of Legal and Compliance Practices in Healthcare Data Utilization” (Seminar Info, Inc.), December 15, 2021

“Biomedical Personal Information Protection Regulation Seminar – For Safe and Secure Use of Biological Samples and Data – Part 2 (Practical session): What is the Correct Handling of Clinical and Genetic Information (Acquisition, Use, Management, and Provision)” (CIBER (Council for Industrial Use of Biological and Environment Repositories)), November 17, 2021

“Biomedical Personal Information Protection Regulation Seminar – For Safe and Secure Use of Biological Samples and Data –  Part 1 (Introductory Session): Basics of Personal Information Protection Regulation in the Biotechnology Field” (CIBER (Council for Industrial use of Biological and Environment Repositories)), October 20, 2021

“Femtech Community: 4th Event: Domestic Institutions and Policies for Promoting Femtech – Latest Trends and Future Initiatives” (Femtech Community Japan), June 17, 2021

“Regulatory Challenges and Company Responses to FemTech Products”, (Second Pharmaceutical Law Study Session sponsored by the Medical FemTech Consortium (MFC)), June 8, 2021.

“Digital Health and Regulations” (Healthcare Working Group, Licensing　Executives Society JAPAN), May 26, 2021

“Key Legal and Compliance Practices in the Utilization of Healthcare Data” (Seminar Info, Inc.), November 5, 2020.

“Legal Compliance System Required of Healthcare Companies under the Revised Pharmaceuticals and Medical Devices Act” (LexisNexis Japan K.K. / Business Law Journal), October 28, 2020.

“Fundamentals of Regulations and Key Points for Regulatory Compliance in Healthcare Data Utilization” (R&D Support Center), October 21, 2020.

“Recent US Judicial Precedents regarding Commercially Reasonable Effort and Points to Remember When Drafting a Contract in Light of COVID-19” (the Japan Pharmaceutical Industry Legal Affairs Association’s Study Group on International Issues)  July 16, 2020

“The 2019 Proposed Amendments to the Pharmaceuticals and Medical Devices Act and Their Impact on Medical Device Manufacturers” (AMDD (American Medical Devices and Diagnostics Manufacturer’s Association) Legal Compliance Committee), July 25, 2019

“Artificial Intelligence and Intellectual Property in Japan: A Deep Dive into Applications, and Legal and Policy Issues” (Brand & New, Podcasts from the International Trademark Association) March 12, 2019

“From the Ground Up: The Latest IP Information Related to Pharmaceutical Patents such as the China/Taiwan Patent Linkage System”(Johokiko Co., Ltd) August 2018

“Workplace Harassment Comes in Many Forms: How Can You Help Your Company Prevent and Deal with Harassment in the Workplace?” (The Japan In-House Counsel Network, JICN) February 2018

“License Agreements with U.S. Companies: Provisions Which Japanese Companies Should Carefully Consider – With a Focus on Provisions Regarding Infringement and Intellectual Property under Japanese and U.S. Law.” (the Japan Pharmaceutical Industry Legal Affairs Association’s Study Group on International Issues) December 2017

“The Application of Artificial Intelligence (AI) and its IP Law Aspects in Japan” (EU-Japan Centre for Industrial Cooperation) September 2017

“A Comparison of Boilerplate Used in English Contracts – With a Focus on Japanese and New York Law” (Seminar for Japan Pharmaceutical Industry Legal Affairs Association) July 2017

“2015 Amendment to the Federal Rules of Civil Procedure” (Seminar for Japan Pharmaceutical Industry Legal Affairs Association) January 2016

“Market Trend of Foreign M&A Contractual Provisions and Point of Compromise for Agreement – Especially on US Non-Public Companies’ Acquisition Cases” (Finance Facsimile News Seminar)  September 2014