FemTech Knowledge Hub with Covington
Together with leading law firm Covington and Burling, we are bringing you three virtual workshops to equip you with the right legal knowledge to make your women’s health and femtech startups a success.
Join us for a series of dynamic and informative sessions that will educate and answer your legal questions. Over the next few months, our partners at Covington will cover the following topics:
📌 12 October 2023 (6pm-7:30pm BST): Regulatory Strategies and Considerations for Launching Women's Health and FemTech Products by Sarah Cowlishaw and Pam Forrest
📌 16 November 2023 (6pm-7:30pm GMT): Navigating Data Privacy Considerations for Women’s Health and FemTech Startups Libbie Canter and Anna Sophia Oberschelp de Meneses
📌 7 December 2023 (6pm-7:30pm GMT): Partnering and Licensing Considerations for Women's Health/FemTech Startups by Winsome Cheung and Sara Needles
*These sessions will be recorded and the recordings will be shared via email with everyone who registered.
12 October 2023 (6pm-7:30pm BST): Regulatory Strategies and Considerations for Launching Women's Health and FemTech Products by Sarah Cowlishaw and Pam Forrest
In this session, Sarah and Pam will cover:
(Potential) product categories for Women's Health/FemTech products
Jurisdictional approaches to Women's Health/FemTech regulation
Developing a premarket strategy for the U.S. and EU/UK
Key differences between U.S. and EU/UK medical device and diagnostic landscape
Regulatory developments for digital health products
Sarah Cowlishaw is a Life Sciences Regulatory Partner and co-chair of Covington's Digital Health Initiative. Sarah supports innovative companies on regulatory, compliance, transactional, and legislative matters. She has extensive experience in advising on pre-market EU/UK regulatory launch strategies with particular expertise in medical devices and diagnostics, and on legal issues presented by digital health technologies. Sarah regularly advises companies in the FemTech and Women's Health sector navigate regulatory considerations from pre-market strategies through to post-market compliance.
Pam Forrest co-chairs Covington’s Medical Device Practice. She has over 25 years of experience advising clients on a broad range of U.S. FDA regulatory issues, with a specific focus on medical device and digital health legal and regulatory matters. She frequently advises firms in the FemTech/Women’s Health sector on the full suite of FDA medical device requirements, including counseling them on market entry strategies, shepherding them through the FDA regulatory process, and helping them to come into compliance with FDA’s postmarket controls. Pam is also a recognized expert on FDA enforcement and works closely with firms on responses to FDA enforcement actions, including inspectional observations and Warning Letters.
16 November 2023 (6pm-7:30pm GMT): Navigating Data Privacy Considerations for Women’s Health and FemTech Startups by Libbie Canter and Anna Sophia Oberschelp de Meneses
In this session, Libbie and Anna Sophia will cover:
US Privacy Laws
FTC Act and recent digital health enforcement
State consumer health data laws
Other state privacy laws
EU and UK Privacy Laws
Key Privacy Principles in Digital Health
Libbie Canter is a vice chair of Covington’s global data privacy and cybersecurity practice. She represents a wide variety of multinational companies on privacy and cyber security issues, including helping clients with their most complex privacy challenges and the development of governance frameworks and processes to comply with global privacy laws. She routinely supports clients on their efforts to launch new products and services involving emerging technologies, and she has assisted dozens of clients with their efforts to prepare for and comply with federal and state privacy laws, including the California Consumer Privacy Act and California Privacy Rights Act. She also advises companies from all sectors on compliance with laws governing the handling of health-related data.
Anna Sophia Oberschelp de Meneses is an associate in Covington's Data Privacy and Cybersecurity Practice Group. Anna advises companies on European data protection law and helps clients coordinate international data protection law projects. Anna also advises companies in the field of EU consumer law and has been closely tracking the developments in this area. Anna is a qualified Portuguese lawyer, but is both a native Portuguese and German speaker. Her extensive language skills allow her to monitor developments and help clients tackle EU Data Privacy, Cybersecurity and Consumer Law issues in various EU and ROW jurisdictions.
7 December 2023 (6pm-7:30pm GMT): Partnering and Licensing Considerations for Women's Health/FemTech Startups by Winsome Cheung and Sara Needles
In this session, Winsome and Sara will cover:
Types of partnering opportunities for Women's Health/FemTech products
Diligence considerations for the evaluation of (or evaluation by) potential partner
Key IP and Licensing considerations for partnering transactions
Key operational considerations for partnering transactions
Winsome Cheung is a life sciences transactions partner based in London. She advises life sciences companies on their strategic licensing and partnering transactions, and intellectual property and commercial matters throughout the entire product life cycle. Prior to her legal career, Winsome was a scientist, and she has a particular interest in advising on transactions involving innovative technologies for a range of life sciences clients, from start-ups to global pharmaceutical companies.
Sara Needles advises pharma, biotech and digital health clients on transactional matters across the full lifecycle of their drug products, biologics, medical devices and technologies. Her practice spans R&D collaborations, strategic licensing arrangements and other complex clinical and commercial transactions in the life sciences space, with a particular focus on early-stage companies. Sara is based in Washington, D.C. and is a member of Covington’s Digital Health Initiative, which focuses on the complex commercial and intellectual property considerations that arise at the intersection of information technology, life sciences and healthcare.
About Covington
Covington & Burling LLP (Covington) is a pre-eminent international law firm with more than 1,300 attorneys and advisors and offices in Beijing, Boston, Brussels, Dubai, Frankfurt, Johannesburg, London, Los Angeles, New York, Palo Alto, San Francisco, Washington, Shanghai, and Seoul. They are known for the high quality of their work, in-depth knowledge of key industries, sophistication in complex corporate, regulatory, advisory, and contentious matters, deep loyalty to clients, and commitment to the highest professional and ethical standards. They are known for creating novel solutions to their client’s toughest problems, successfully trying their toughest cases, and delivering commercially practical advice of the highest quality. Covington is also known for being a leader in the Life Sciences sector and has a dedicated Digital Health team that offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services.
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