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Regulatory Symposium: New Horizons in Data, AI, and Cyber Strategies in Global Life Sciences
With the speed of innovation accelerating the regulatory framework is working to catch up, the world over. The European Union has passed a myriad of new legislation, which is coming into force and will dramatically affect the use of AI and the development of digital health tools. Changes in large markets have a global impact in the way businesses operate. Understanding these impacts is imperative to the success of life sciences businesses, whether they are using AI to develop medical devices, drugs and biologics, or the AI is the product.
Join us for an in depth look at the United States and Europe’s Data, AI, and Cyber Strategies with industry experts from Hogan Lovells and the CSA Group, in addition to insights from global life sciences companies who are preparing for the changes.
Meet Our Speakers
Arne Thiermann, LL.M. (LSE)| Partner, Global Regulatory Hogan Lovells
With a background in intellectual property law, Arne regularly handles licensing and development transactions in all stages of drug or device development. He further provides advice on strategic supply and manufacturing arrangements and helps you setting up R&D, marketing and distribution collaborations. You may also seek Arne’s advice on regulatory issues in the context of researching, developing, marketing and distributing pharmaceutical products and medical devices.
Finally, Arne helps you marketing and advertising pharmaceutical products and medical devices in compliance with applicable laws and industry codes. He specifically assists life sciences clients on how to properly interact and collaborate with health care professionals.
His goal is to show a solutions-oriented approach and deliver pragmatic solutions to his clients. Arne is listed as Name of the Next Generation for Industry focus: Healthcare in Legal 500 Germany in 2020 and 2021 and as often recommended lawyer for Pharmaceuticals and Medical Devices in JUVE handbook since 2016. Further he is acknowledged as noted practitioner for Life Sciences in Chambers Europe since 2015. Clients like working with him “because of the excellent work, the pragmatic approach, the high level of expertise and the trust that has grown over many years.” (Legal 500 Germany, 2021) and praise him as “reliable, innovative and solution-oriented” (JUVE handbook, 2020/2021).
He regularly holds external and in-house presentations and seminars on regulatory topics and commercial contracts.
Fabien Roy | Partner, Global Regulatory | Hogan Lovells
Fabien guides clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices and assists clients in addressing complex issues during clinical investigation procedures (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data), conformity assessment and registration procedures (e.g. prepare and review of technical documentation, prepare and review of responses to the competent authorities’ and Notified Bodies’ requests) and post-market activities (e.g. adverse event reporting, Field Safety Corrective Actions and promotional and advertising of medical devices).
Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device clients. Fabien also assists clients in preparing, drafting and review of numerous agreements including clinical study agreements, sponsor’s representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.
Jodi Scott| Partner, Global Regulatory | Hogan Lovells
Jodi Scott developed and honed her practical, real-world sensibility and business acumen during the time she spent as an in-house FDA counsel with Medtronic PLC, the world’s largest medical device manufacturer.
Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses), developing digital health technology, and securing the necessary state medical device manufacturer and distributor licenses.
Jodi assists the medical device industry in navigating the complex requirements so as to maintain compliance with the U.S. Food and Drug Administration’s (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.
She also guides her clients through complex medical device recalls by helping them work through the difficult decisions of whether a recall is warranted and, if so, how to execute it in a way that best achieves a balance between patient and customer risk and the agency’s interests, while also demonstrating the company’s commitment to safety and its regulatory obligations.
She also applies her regulatory knowledge in assisting clients with regulatory due diligence related to mergers and acquisitions and funding, such as private equity deals, initial public offerings, and other financial transactions.
Jodi co-leads the firm’s cross-functional Digital Health Working Group and regularly assists clients in navigating the complexities of FDA regulation of digital health technologies with an eye to helping them meet their business objectives while being mindful of the potential for regulatory obligations.
Shane O’Neill | New Business Account Manager | CSA Group
Shane O’Neill boasts more than 15 years of expertise in testing, inspection, and certification (TIC), directing medical device manufacturers towards achieving compliance with regulatory standards. Presently employed at CSA Group, a leading global TIC organization, he focuses on facilitating successful market entry for clients worldwide, holding accreditations across North America, Europe, and more than 100 other global markets.
Mani Venkatesh | Vice President, Digital Transformation | Terumo Blood & Cell Technologies
Mani Venkatesh leads the Digital Transformation Office for Terumo Blood and Cell Technologies and is a member of the Executive leadership team. Mani leads TBCT’s enterprise-wide effort to identify and embrace new relevant digital technologies with an aim to transform our customer’s experiences.
He joined the company in 2020 and was previously responsible for the development of all software products, both embedded software that is core to operation of the devices and the application software that supports the fleet wide management of these devices. Mani has led and delivered critical software platforms using cutting-edge technologies and robust architectural patterns.
Mani brings over 25 years of experience in building and delivering software platforms for the medical device industry. During his tenure, he has had experiences in all the various aspects of product development including Architecture, Design, Systems Engineering, IT, project mnagement and VnV. He is well versed in applying Agile development practices and constantly collaborates with customers to deliver the right outcomes. He is constantly looking to improve internal efficiencies while delighting customers by adopting cutting edge technologies that can satisfy the unmet needs of donors and patients.
Mani has a Bachelor of Science degree in Computer Engineering from Mumbai University and a Master of Science in Computer Science from Lamar University.
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