Around the world: regional perspectives on the regulation of AI and Software as a Medical Device

Sanjeev is Practice Chair, Litigation at K&S Partners. Sanjeev is an IP litigator with experience over 23 years and specializes in Patent and Design Litigations. Sanjeev's main areas of work involves litigation, patent invalidation, IP licensing & transnational and IP due diligences. Sanjeev is based out of New Delhi.

Yuri Inoue specializes in both domestic and cross-border M&A⁠, while leveraging her graduate studies in medical devices and entrepreneurship to provide expertise in transactions such as M&A⁠, licensing⁠, collaboration⁠, contract manufacturing and technology transfer⁠, as well as related regulations⁠, within the pharmaceutical and medical device sectors⁠. Having lived extensively in the United States⁠, Germany and Spain for a total of about 13 years⁠, she is particularly skilled at managing cross-border projects⁠. Her aim is to bridge cultural gaps and support companies in their international expansion and growth⁠, ultimately contributing to their global business success⁠.

Beth Weinman is a member of the firm’s life sciences regulatory & compliance practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices, cosmetics and dietary supplements. As a former lawyer with the U.S. Food and Drug Administration, Beth brings valuable perspective to clients who turn to her for representation in government investigations, assistance with internal compliance investigations, FDA enforcement actions, product recalls and other agency engagement strategies. Clients frequently look to Beth for representation when facing government investigations or engaging with FDA on regulatory compliance matters, particularly in connection with alleged manufacturing practice violations or inappropriate marketing. She has extensive experience representing clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, internal compliance investigations, and other enforcement actions before state and federal regulators. In addition, she regularly counsels clients through product recalls and withdrawals, responses to 483s and warning letters, and matters regarding marketing practices, manufacturing practices, data integrity issues and good clinical practices. Beth also represents clients in administrative litigation. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the U.S. Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes (e.g., mail fraud, wire fraud, health care fraud, and conspiracies to defraud) under Title 18. She also worked on numerous parallel and independent FCA investigations involving FDA-regulated drugs and devices, and has significant experience in opioid-related investigations. Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where she represented several pharmaceutical companies in government investigations and securities class-action lawsuits, among other matters.

Based in Shanghai, China, Frank has practiced law for more than 20 years in both international and Chinese law firms. He advises clients on mergers and acquisitions, private equity and licensing deals, with a focus on the Healthcare and Life Sciences sector. He also assists many bio-techs, bio-pharmas, and big pharmas in relation to their corporate and regulatory matters, covering NMPA compliance, human genetic resources, health data, customs law, export control and anti-corruption. Frank co-chairs the firm’s life sciences and healthcare practice group and is chief editor of the firm's monthly life science and healthcare journal. He is recommended lawyer in the Life Sciences sector by Legal 500 for many years.