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RCA Radio

Regulatory Compliance Associates

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RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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DarshanTalks Podcast

Darshan Kulkarni

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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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Hemp Legally Speaking

Jonathan Miller - National Leading Hemp Attorney & Advocate

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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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AHLA's Speaking of Health Law

American Health Law Association

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The American Health Law Association (AHLA) is the largest nonprofit, nonpartisan educational organization devoted to legal issues in the health care field. AHLA's Speaking of Health Law podcasts offer thoughtful analysis and insightful commentary on the legal and policy issues affecting the American health care system.
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Quality Grind Podcast

MEDVACON Life Sciences

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Welcome to The Quality Grind Podcast, presented by Medvacon! Join hosts Joe Toscano, President of Medvacon, and Mike Kent, Director of Learning Platforms, as they (we) have some fun while tackling topics related to the “everyday grind” within Life Science industries. Featuring conversations with key industry players, they’ll dive into their unique problem-solving strategies, career paths and personal interests. Most importantly, their (our) goal is to cultivate a community where information ...
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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PwC's Next in Health

PwC's Health Industries

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Co -hosted by Glenn Hunzinger, US Health Industries leader, and Jennifer Colapietro, Consulting Commercial Leader, the Next in Health podcast series offers insights on the most important issues facing pharma, medtech and healthcare. PwC business leaders discuss the latest trends and their impact on health industries, whether it’s policy, AI, innovation, care delivery, business model reinvention or bold moves for the future. If it’s happening in health industries, we’re talking about it.
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$1 Pound Show

CannabisPermits.com

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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Anesthesiology News Presents

Anesthesiology News, James Prudden, Paul Bufano

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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people who may have the answers. Whether you're background is Pharma, Device or both, I invite you to li ...
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16 Minutes News by a16z

Andreessen Horowitz

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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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MAKING IT TO MARKET - WITH DAHLIA KELADA

Making it to Market - Dahlia Kelada

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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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In a groundbreaking development for the digital health world, Eli Lilly, one of the world’s largest pharmaceutical companies, has filed lawsuits against a growing number of telehealth companies over the sale of compounded drugs Mounjaro and Zepbound, two popular GLP-1 medications. Nawa Lodin, Associate, Wilson Sonsini Goodrich & Rosati, and Lauren …
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Rob Gerberry, Senior Vice President and Chief Legal Officer, Summa Health, speaks with Michael Peregrine, Partner, McDermott Will & Emery, about the Department of Justice Criminal Division’s recent release of its new white collar criminal enforcement plan and the board’s oversight responsibility for corporate compliance with the law. They discuss h…
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In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multip…
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Jonathan Miller interviews Justin Swanson, President of the Midwest Hemp Council, about legislation being considered by the House Appropriations Committee that could ban most consumable hemp products. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered…
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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particula…
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Rachel goes down the rabbit hole of why prison labor can be so concerning, and its not for the reason you think. Incentives matter, and should we be incentivising incarceration in a free society? When lots of big interests are making lots of money off of prisons and prison labor, what do you think happens to the demand for more prisoners?…
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Operation Brace Yourself, a massive 2019 Department of Justice operation involving the durable medical equipment (DME) industry, was one of the largest health fraud enforcement actions in history and had major legal and compliance repercussions for DME companies. In this two-part series, Stephen Lee, Solo Practitioner, Law Office of Stephen Chahn L…
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Did you know that consolidation in the fertilizer industry results in environmental harm and less choice for farmers? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the Eli…
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In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors. They discuss examples…
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On this episode of Culture & Compliance Chronicles, Amanda Raad and Nitish Upadhyaya from Ropes & Gray’s Insights Lab, and Richard Bistrong of Front-Line Anti-Bribery, are joined by Nicole Rose, a compliance specialist and creative artist based in Australia who shares her unique insights on how creativity helps solve compliance challenges. Nicole d…
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If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It’s meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regul…
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Send us a text Welcome back to the Grind, where Joe and Mike continue their exploration of Cell & Gene Therapy with expert Ray Kaczmarek. In this episode, part 2 of our 4-part series, Ray provides perspective on navigating the development process, highlighting some key factors for success – robust science, integrous data and stage-appropriate syste…
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Building a strong food safety culture requires deep organizational commitment and the systematic implementation of best practices across every level of operations. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Dinesh Babu, Vice President of Quality and Food Safety at State Garden, for an i…
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Operation Brace Yourself, a massive 2019 Department of Justice operation involving the durable medical equipment (DME) industry, was one of the largest health fraud enforcement actions in history and had major legal and compliance repercussions for DME companies. In this two-part series, Stephen Lee, Solo Practitioner, Law Office of Stephen Chahn L…
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On this episode of Fully Invested, Ropes & Gray asset management partner Jessica Marlin and capital markets counsel Marc Rotter discuss ’34 Act Registered Private Funds. These funds register under the Securities Exchange Act of 1934 and disclose information publicly, while remaining exempt from the Investment Company Act of 1940. Jessica and Marc e…
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In this episode, Darshan Kulkarni sits down with Marie Ange Noue, Senior Director and Head of Scientific Communications at EMD Serono, to dive deep into the increasingly common practice of medical affairs teams creating dedicated LinkedIn handles. Marie explains that this trend is driven by healthcare professionals’ evolving preferences for receivi…
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In this episode, Edye and Darshan dive into the controversial but critical question: Are we paying patients enough to participate in clinical trials? And if not, how can we ethically and compliantly pay them more? Key Takeaways: The Coercion Concern Compensation for trial participation is often scrutinized by IRBs due to concerns around coercion. H…
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Did you know that consolidation in our food and agriculture systems has more to do with the price of eggs than bird flu? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Basel Musharbash, antitrust and trade regulation lawyer, and author of Kings Over the Necessaries of Life: Monopolization and the …
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Google’s 2024 ad safety report just sent shockwaves through the pharma and device industries. With AI now faster, smarter, and more ruthless, Google blocked over 5.1 billion ads last year and restricted 9.1 billion more. Healthcare ads were hit especially hard, with over 106 million healthcare and medicine ads being blocked. If you’re still relying…
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Send us a text Welcome to The Grind! Hosts Joe Toscano and Mike Kent caught up with special guest Ray Kaczmarek in San Diego for an insightful discussion highlighting the complexities and dynamic nature of Cell and Gene Therapy. In this episode, the first in a 4-part series, Ray shares his experiences from military service to multiple C-suite roles…
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You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from…
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, and Phil Scalfani, PwC’s Pharmaceutical and Life Sciences Consulting Leader, discuss the Trump administration’s executive order on Most Favored Nation (MFN) drug pricing and its far-reaching implications across the healthcare ecosystem. They break down what MFN pricing could mean for pharm…
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Jackie Selby, Partner, Epstein Becker & Green PC, Maria Nikol, CEO, Revelar Analytics LLC, and Karen Mandelbaum, Senior Counsel, Epstein Becker & Green PC, discuss current trends and developments related to price transparency. They cover why price transparency is important; provide an overview of the hospital transparency rule and the transparency …
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Jonathan Miller interviews Austin, Texas lobbyist Frank Santos, about the ever-changing state of play for hemp policy in Texas. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: What is Senate Bill 3 and how did it pass the legislatur…
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In this episode Edye Edens and Darshan Kulkarni tackle a hot-button issue in clinical trials: Should all screen fails be paid for? The discussion was sparked by a recent wave of community questions and contract examples around this very topic. From the sponsor’s perspective, concerns center around cost control and compliance. Sponsors fear that pay…
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Linda A. Michler, Arbitrator and Mediator, speaks with Christopher C. Murray, Partner, Ogletree Deakins, about arbitration in the health care employment space. They discuss how arbitration works; the strengths and weaknesses of arbitration; and issues related to selecting an arbitrator, cost, mediation, class action waivers, and mass arbitration. T…
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Did you know that some food dyes can have a negative influence children’s behavior? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Peter Lurie, MD, MPH, President and Executive Director of the Center for Science in the Public Interest (CSPI), a non-profit food and health watchdog organization base…
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Send us a text In this episode of the Quality Grind Podcast, host Mike Kent welcomes Jose Mora back to discuss the application of Lean principles in regulated life science environments. Tune in as they dive deep into the importance and utility of Lean, with plenty of real-life stories from across product development and commercial manufacturing. Le…
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On this third episode of Ropes & Gray’s Insights Lab’s four-part Multidimensional Data Reversion podcast series, Shannon Capone Kirk and David Yanofsky discuss the crucial steps in the iterative cycle of data analysis, visualization, and insight. They delve into the complexity of using free text in data analysis, explaining how unstructured text di…
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In this episode, we explore a crucial and timely issue: how the Trump administration’s approach to antitrust enforcement—combined with new state-level regulations—is creating a shifting legal environment for life sciences companies, especially those involved in mergers and acquisitions (M&A). At the federal level, Assistant Attorney General Gail Sl…
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Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why reg…
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On this Ropes & Gray podcast, Alyssa Horton and Colleen Meyer, both counsel in the private funds regulatory group, explore the recent SEC staff guidance on the Marketing Rule. They discuss the new FAQs issued on March 19, 2025, which address the presentation of investment-level returns and investment characteristics. Colleen and Alyssa provide a co…
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What if you could extend food shelf life while also reducing plastic waste? In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Johnathan Raineau, President of Copperprotek USA, to discuss how copper-based antimicrobial technology is transforming the future of food packaging. Learn how this FD…
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Andrew Mahler, Vice President of Privacy and Compliance Services, Clearwater, speaks with Kathleen Healy, Partner, Robinson Cole, and Robert Martin, Senior Legal Counsel, Mass General Brigham, about how health care compliance teams can build effective governance models, monitor legal risks, and prepare for enforcement activity related to artificial…
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Transferring medical device ownership during a company sale requires careful planning to ensure compliance and operational continuity. The process begins with accurate documentation of 510(k) clearance and thorough due diligence to avoid regulatory delays. Next, companies must assess ongoing clinical trial responsibilities and contractual obligatio…
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Matt Rich, PwC’s Pharma and Life Sciences R&D Leader, to unpack the recent disruption at the FDA and what it means for the pharmaceutical and biotech sectors. They discuss how companies can stay agile in the face of regulatory uncertainty, avoid preventable delays, and take p…
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Gerald (Jud) DeLoss, CEO, Illinois Association for Behavioral Health, Tania Archer, Counsel, Moore & Van Allen, Allison Petersen, General Counsel, INTEGRIS Health, and David Shillcutt, Partner, Epstein Becker & Green, discuss hot topics in behavioral health, including trends in managed care behavioral health, federal and state funding for behaviora…
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Did you know that Roundup for residential /consumer use has been re-formulated to replace glyphosate with even more harmful chemicals? Join Food Sleuth Radio host and Registered Dietitian, Melinda Hemmelgarn for her conversation with Kendra Klein, PhD., Deputy Director of Science at Friends of the Earth. Klein describes new formulations, health ris…
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader and Roel van den Akker, PwC’s Pharma and Life Sciences Deals Leader discuss the rapid rise of China’s biotech industry and what it means for U.S. pharmaceutical companies. They discuss the evolving role of Chinese biotech in the global innovation landscape and share perspectives on how U.S.…
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At first glance, responding to site-level findings seems simple—but when Edye and Darshan dug into the details, it became clear that the lines of responsibility blur fast. Here's how each side sees it: Site Perspective: Sites know the boots-on-the-ground reality. When a finding is made—especially during an external inspection like the FDA—they’re o…
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Send us a text In this Quality Grind Short, we delve into the concept of coachability and its critical role in organizational effectiveness and team success. We explore how individuals and teams can become more open to feedback, shift their behavior, and embrace a mindset geared towards learning and improvement. The episode highlights the importanc…
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Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards…
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Medical communications teams must exercise caution when using websites dedicated to medical affairs, as legal risks go beyond overt sales promotion. Drug and device manufacturers face compliance challenges, particularly when these platforms are accessed by broader audiences, including non-scientists. Key risks include: Off-Label Promotion: The Fact…
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As ransomware attacks grow more sophisticated, health care organizations face not just massive data privacy risks, but real-time threats to operations, patient safety, and regulatory compliance. Dave Bailey, Vice President of Security Services, Clearwater, speaks with Kirk Nahra, Partner, Wilmer Hale, and Paul Schmeltzer, Member, Clark Hill, about …
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Jonathan Miller interviews Anthony Newby, CEO of Cultivated CBD, about issues of justice and equality in the hemp and cannabis industries. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: Why have the hemp and cannabis industries bee…
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At the Save Our Sites (SOS) conference, many site owners expressed excitement over finally having a space to openly discuss real challenges—budgets, pricing, contracting, and the isolation of being a site owner. While the intent was mutual support, concerns quickly arose when some attendees began advocating for standardized pricing across sites (e.…
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Medicare Advantage (MA) is one of the most popular insurance programs for the Medicare-eligible population, however it faces significant headwinds from both payer and provider organizations. Alan Lassiter, Principal, ECG Management Consultants, speaks with Christine Worthen, Member, Epstein Becker & Green PC, and Joe Mangrum, Partner, ECG Managemen…
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