Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China – FDA Watch
In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington’s European Food, Drug and Device Practice; John Balzano, Partner in Covington’s China Food, Drug and Device Practice; and Julia Post, Of Counsel in Covington’s U.S. and China Food, Drug and Device Practices. Together, they discuss the top issues in the global device landscape; developments in the European and Chinese medical device spaces; cross-border access to and transfers of U.S. and Chinese data and biospecimens; how Europe and China are approaching digital health and AI in device regulation; what device companies doing business in the U.S., European Union and China should be watching for over the next year; and much more.
This episode and the rest of our series do not include the usual Headlines and Resources Links segments.
About Our Guests
Sarah Cowlishaw
Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.
Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.
Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.
John Balzano
John Balzano has over twenty years of experience with legal and regulatory issues related to China and the Asia Pacific Region (APAC), particularly with regard to products regulated in Mainland China by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China and APAC, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.
He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, implementing product recalls, and supporting virtual and onsite overseas quality inspections. John also has significant experience designing strategies to handle professional consumer litigation for companies operating in China and working with local counsel.
He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.
He is the author of the book, China Food and Drug Law: Policy, Practice, and Future Directions (Springer 2024).
Julia Post
Julia Post advises companies and trade associations on a broad range of regulatory and policy matters related to drugs, biologics, and other regulated products in both the U.S. and China. Julia has significant experience in advising clients on clinical trial and product development matters, including informed consent requirements, biospecimen procurement and research use, and other good clinical practice. She advises clients regularly on product life-cycle management issues, including patent linkage frameworks and marketing exclusivity in the U.S. and China.
Julia works with pharmaceutical, medical device, food, and cosmetics clients on complex regulatory compliance matters and helps them develop their advocacy strategies before U.S. and China regulators, at both national and local levels. She regularly assists companies and trade associations on policy issues, including the development and submission of comments on legislative and regulatory proposals. Julia works closely with local counsel throughout the Asia-Pacific region to assist clients with their marketing approval and compliance strategies.
Prior to joining the Food, Drug, and Device practice group, Julia was a member of the Litigation practice group where she focused on representing clients in Hatch-Waxman patent litigation.
Julia has an active pro bono practice at Covington, with a particular focus on reproductive justice matters and representation of third-party caregivers and children in custody cases.
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