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McGuireWoods is proud to be a sponsor of ACI’s 29th Annual Conference on Drug & Medical Device Litigation. Partner Nicholas J. Hoffman will be leading the panel “AI v. ASSOCIATE: Rethinking the Role of AI in Legal Practice and Trial Strategy.” Each year, this conference brings together hundreds of products liability defense stakeholders from industry, private practice and government to network, collaborate and strategize on the current products liability landscape and to anticipate what is …

… manufacturing, food and beverage, and retail industries continue to face an ever-evolving landscape of new regulations, regulatory actions and lawsuits focused on labeling. This spine-tinglingly frightful discussion with members of McGuireWoods’ food and beverage and product labeling teams reviews recent regulatory and litigation developments now “haunting” these industries and what these developments mean for the future. The presentation also includes a brief section on recent litigation affecting popular Halloween candies. Speakers R …

Join fellow healthcare leaders together for an interactive program discussing the latest developments in the industry and the challenges the industry faces in 2024 and beyond. With substantive panels and ample networking breaks, this year’s conference will provide opportunities to connect with and learn from industry colleagues on how best to navigate opportunities, emerging subsectors, and unique challenges of the healthcare industry.

https://youtu.be/y2CDyQYH8rE Download Slides McGuireWoods partners Mindy Sauter, Mike Elliott, Brett Barnett and Michael Podberesky conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the private equity space. Related blog post: Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare For more information or questions, please …

https://youtu.be/BpH3arrPDJ4 Download Slides McGuireWoods' Samuel C. Bernstein, Royce B. DuBiner and Allyson M. Maur discuss the impact of the FDA’s final rule on laboratory developed tests (LDTs). The trio discuss the FDA’s amendment to its regulation of in vitro diagnostic products (IVDs), including implications for LDTs on the market and whether alternative pathways may be available before the end of the FDA’s four-year phaseout of enforcement discretion. They …

https://youtu.be/geEpgGCacCI Download Slides Join attorneys from McGuireWoods and Bourne Partners' Jeremy Johnson, Managing Director and Head of Investment Banking, and Jake Curtis, Vice President, Pharma Services, for an update on market trends, innovations and advancements that could shape the pharma services landscape in 2024. Login details will be sent to registrants upon registration. CLE credit applications will be made on behalf of attendees who participated during the live presentation. Our programs are …

Partner Davis M. Walsh will be a featured panelist on the topic of "Navigating the Opportunities and Perils of AI-Assisted Legal Representation and Trial Practice" at this year's ACI Drug and Medical Device Litigation Conference. Each year, for over a quarter of a century, ACI’s “Drug and Med” conference has brought together hundreds of products liability defense stakeholders from industry, private practice, and government to network, collaborate, and strategize on the current …

Partner Davis M. Walsh will be a featured panelist on the topic of "Assessing the Impact of the Recent Supreme Court Session on the Drug and Medical Device Industry and Upcoming Preemption Battles" at this year's ACI Drug and Medical Device Litigation Conference. Each year, for over a quarter of a century, ACI’s “Drug and Med” conference has brought together hundreds of products liability defense stakeholders from industry, private practice, and government to …

A little over a year ago, we saw many of you at our 17th Annual Healthcare Private Equity & Finance Conference. We were grateful to get together and be able to provide an environment rich with networking and conversation between clients, colleagues and industry leaders. After strongly considering an in-person conference for late summer or early fall of 2021, out of an abundance of caution, we have made the decision to forgo the event this …

Partner Kate W. Hardey will moderate on “Will Increased Supply Options Affect Marijuana Research and Drug Development?" at the 2021 Legal and Practical Issues in the Evolving World of Cannabis Regulation Agenda, hosted by the Food and Drug Law Institute (FDLI).This conference will examine the present reality of this unique industry from both a legal and practical perspective and guide attendees on how to navigate this constantly changing legal environment. Industry experts will untangle …

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https://www.youtube.com/embed/gw8lcg5da7Q Download Slides Update: The final rules discussed in the alert below were given a Jan. 19, 2021, effective date. Since publication, however, the Government Accountability Office concluded that the final rules did not have a required 60-day delay in their effective date. Meanwhile, on Jan. 20, 2021, the Biden administration paused final rules from taking effect from the Trump administration. McGuireWoods will be reviewing further guidance from the …

https://www.youtube.com/embed/XjyR1wpjFKE Download Slides Join McGuireWoods for the second webinar in this three-part series, covering discounts, rebates and value-based pricing models for medical device and pharmaceutical companies. In the current enforcement environment, it is unclear whether the Office of Inspector General of the U.S. Department of Health and Human Services will issue safe harbors to the federal Anti-Kickback Statute to protect value-based pricing structures offered by …

Join McGuireWoods’ intellectual property team for a webinar on strategic considerations for pharmaceutical and medical device companies in litigating post grant proceedings before the U.S. Patent and Trademark Office. Discussion will cover the interplay between inter partes reviews and Hatch-Waxman cases, including proving or rebutting secondary considerations, proving or rebutting that a reference is a printed publication, and assessing issues regarding multiple petitions, parallel proceedings, time bar and estoppel. McGuireWoods Presenters Benjamin C …

11 a.m. - Noon PDTWith the increasing complexity and frequency of biopharma M&A transactions, how do you ensure that synergy targets are met or exceeded? What are some of the key success factors, and what are some of the biggest 'real-world' pitfalls and watch-outs to address? This panel, including McGuireWoods partner Kate Hardey, will explore these topics with highly experienced “roll-up-the sleeves” executives who have succeeded in M&A where …

Partners Kate Hardey and Seth Goldsamt participated in this event. DBKIO is a life sciences conference merging innovators, business developers, and investors with discussions around the international business and medical development. Kate moderated a discussion on "Fireside chat: Getting from the Clinic to Value, Lessons from Novartis." Seth moderated and participated in a discussion on "The ABCs of Financial Tools in the Toolbelt."For more information, please visit the event's website.

9:30 – 10 a.m. Registration10 a.m. – 4 p.m. Program and LunchSponsored by: CLE credit applications will be made.Updated Agenda >>The life sciences market is in a period of dramatic change. Join us as we explore shifts in the regulatory environment and business issues affecting life sciences companies and their investors.Presentation MaterialsKeynote SpeakerFDA Update: Recent Developments and New InitiativesThe Life Sciences Investor's PerspectiveDigital Health and CybersecurityTopics:FDA regulatory updateDigital health …

New York, NY Thursday, October 18, 2018 Parker New York | 119 West 56th Street 8:30 – 9 a.m. Continental Breakfast 9 – 11:15 a.m. ProgramCharlotte, NC Tuesday, October 23, 2018 The Ritz-Carlton | 201 East Trade Street 3 – 5:15 p.m. Program 5:15 p.m. ReceptionRaleigh, NC Thursday, November 8, 2018 McGuireWoods LLP 434 Fayetteville Street | Suite 2600 12 – 12:30 p.m. Lunch 12:30 – 2:45 p.m. ProgramWe …

12 - 12:30 p.m. Lunch 12:30 - 2:45 p.m. Program1 hour ethics credit anticipated 1 hour professionalism credit anticipated McGuireWoods invites you to attend Tom Spahn's annual ethics program. In the first hour, Spahn will use hypotheticals to explore lawyers’ confidentiality and disclosure duties in the context of non-clients’ misconduct.Confidentiality: Part V Clients’ Past and Ongoing MisconductDuty to disclose clients’ past fraud on tribunals, or past misconduct in noncorporate …

Partners Seth Goldsamt and Kate Hardey participated in this event. Seth moderated a discussion on "Born Global: Strategies for Companies Looking Across Borders," while Kate moderated a discussion on "Creative Deals in Early Development & Long-term Alliance Management" and also spoke on "From Patient to FDA: Insights Into Thinking About KOL Engagement, FDA Approvals, & Ultimately, The Market."

The healthcare and life science markets are in a period of dramatic change. Despite this change, successful private equity funds can still execute deals and achieve capital growth by implementing the right strategies in the right markets. Join us at the premier two-day healthcare-focused private equity, lending and finance conference as we continue to explore new ways to successfully close transactions and achieve growth. This year’s conference will again include presentations by …

8:30 – 9:15 a.m. Registration and Continental Breakfast 9:15 a.m. – 4 p.m. Program and Lunch 4 – 5:30 p.m. Reception CLE credit applications will be made.Join us for an interactive conference addressing business and regulatory issues impacting the pharmaceutical and medical device industries.Download agenda >>Topics Include: Life Sciences Industry UpdateFDA RoundtableHCP Relationships and Current Enforcement IssuesClinical Research Arrangements Intellectual Property Issues in Partnerships and Other CollaborationsCurrent Antitrust …

McGuireWoods professionals participated in this life science industry conference hosted by the Consulate General of Denmark in New York and cosponsored by McGuireWoods.Stephanie Kennan, spoke, and Kate Hardy, moderated, on the topic "Formulary Strategy for 2017 and Beyond: What PBMS and Payers are Thinking" (April 6)Seth Goldsamt, spoke on the topic "Living the Public Life: IPO and Beyond" (April 7)For additional details please click here.