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Listen Medical Device Regulation and Standards
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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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RQM+ industry-leading experts and often special guests discuss regulatory, quality, clinical, lab, and reimbursement challenges MedTech companies are facing. RQM+ is the world's leading MedTech service provider offering consulting, clinical trial, lab, and reimbursement services, as well as technology solutions to support the entire product lifecycle. With more former FDA, Medicines, and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ t ...
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Life Sciences 360 is an interview show that educates anyone on challenges, trends, and insights in the life-sciences industry. Hosted by Harsh Thakkar, a life-sciences industry veteran and CEO and co-founder of Qualtivate, the show features subject-matter experts, business leaders, and key life-science partners contributing to bringing new therapies to patients worldwide. Harsh is passionate about advancements in life sciences and tech and is always eager to learn from his guests— making the ...
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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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Sponsored by UptimeHealth.
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The AI in Business Podcast is for non-technical business leaders who need to find AI opportunities, align AI capabilities with strategy, and deliver ROI. Each week, Emerj AI Research CEO Daniel Faggella and team interview top AI executives from Fortune 2000 firms and unicorn startups - uncovering trends, use-cases, and best practices for practical AI adoption. Visit our advertising page to learn more about reaching our executive audience of Fortune 2000 AI adopters: https://emerj.com/advertise
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Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences ...
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We help medical device professionals deepen their knowledge of customers, the industry, and their role. Our main objective is to help you become expert in your current position, and through a better understanding of others within your company and the best practices in others in the industry, enable you to fast-track your career.
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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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Gradical is the plastics expert for medical technology. We help medical technology companies to select the right plastic for their application. This takes into account technical suitability, regulatory requirements and sustainability aspects. The Gradical podcast covers all topics relating to plastics in medical technology. Sustainability, sterilization, the medical grade concept, biocompatibility and many other topics await you in this podcast. The host Lucas Pianegonda is a plastics expert ...
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The Drug and Therapeutics Bulletin (DTB) Podcast is your source for practical, independent, and evidence-based information on drugs, medication, and prescribing. Join the Editor-in-Chief and Deputy Editor of DTB each month as they discuss the key highlights of the latest issue. DTB - dtb.bmj.com - is published by BMJ Group, and offers rigorous, independent evaluations and practical advice on treatments and disease management for doctors, pharmacists, and healthcare professionals. Subscribe t ...
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Join Sunrise Labs on the Making Bright Ideas Work podcast to discuss the ins and outs of bringing medical devices to life, and their impact on the industry and beyond.
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"Care Team Conversations", is a monthly patient safety focus podcast that provides a forum for Clinical Professionals to talk about best practices, innovations and solutions.
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The Road to Medical Sales Podcast was created to share the experiences of those who have Broken into the Medical Sales Industry. We will be hearing about how they did it and hopefully their "real life" wisdom can help someone else break in! We will also be hearing from the top Medical Sales Reps in the Industry, Surgeons, Sales Coaches, and more!
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Driving adoption of innovative therapies to improve patients' lives... This is what most healthcare industry professionals are passionate about. And so are we! We are Fabienne Durat and Greg Servotte, two senior leaders in the medical device industry, and the hosts of The Leadership Consultation, a.k.a TLC. In each episode, we have an open conversation with a top leader from the healthcare industry to explore topics related to career development, leadership, and business strategy & innovatio ...
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Interviews, editorial viewpoints and discussions around key news items and their impact on global clinical research. Presented by The Institute of Clinical Research, a leading membership organisation for professionals involved with the design, management, conduct and reporting of clinical trials.
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I'm a Fractional Chief Marketing Officer for life science companies and I help them accelerate product adoption & make marketing work. This is LifeSci Continuum, where we explore the unbroken sequence of innovation, strategy, & growth in the life sciences industry. Join us as we explore the insights and experiences of founders, product managers, commercialization leaders, & marketing pros in the field. Discover the strategies & tactics that have worked for them, hear about their challenges a ...
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Kurt Wehrle is a Chicago-based enterprising worldwide business pioneer with 20+ long periods of assorted and progressive P&L management in top-notch Biopharma, Medical Device, and Diagnostic organizations. Kurt Wehrle has a demonstrated history of creating multi-layered worldwide systems, building frameworks, changing business, extending topographies, and creating on the web capacities to essentially expand income and EBITDA.
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SMASH stands for "Serious Medical Advisors Saving Healthcare" and "IT" stands for Information Technology. Through this podcast we intend to invite guests who provide powerful feedback that will impact listeners and help to inspire a revolution in healthcare of those who are like-minded, educated, and technology driven, to engage collectively in the transformation of healthcare as we know it. We will engage in tantalizing topics that surround what it means to think differently when it comes t ...
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Interviews with founders and leaders of tech companies. We explore how they got started, how the industries they operate in work, how they do marketing, and the lessons they've learned so far. This show is for anyone interested in technology, startups, scaleups, SaaS, founder stories, B2B growth and go-to-market strategies.
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EUAudio provides automation professionals with a seamless way to listen in on the biggest manufacturing trends, anytime, anywhere. Covering the industry’s most relevant topics from environmental issues to predictive maintenance, cyber security to supply chain management, each series is carefully curated allowing listeners to develop their knowledge and skill set along the way. Your journey to becoming an automation expert starts here.
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Technology tips and insights to help protect your business! We offer weekly interviews with industry experts and leaders from companies like Coca-Cola, Verizon and AT&T to share their insights on cybersecurity and other technology topics. Join your host, Shaun St.Hill, the CEO of Tech and Main!
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Listen to the latest news from the experts in your field.
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The Next Level Idea podcast is hosted by Eric I. Anderson and takes over where the Orthoidea podcast left off.
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Our hosts Abbey Crane & 17 year SEO industry expert Jeremy Rivera are having unscripted interviews small business owners, founders and creators across the United States, learning about their challenges, successes and insights into the world of SMBs.
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What’s the best way to deal with ISO internal audits? Keep calm, follow a consistent approach, and consider ample time for preparation. This is only a brief account. When it comes to ISO 13485 Standard, you need to understand the complexities of the standard before performing the internal auditing program. If you are responsible for planning and executing internal audits for your organization, you might know how much planning and effort is required to monitor a Quality Management System or Q ...
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Clinical Trial Podcast | Conversations with Clinical Research Experts
Kunal Sampat | Educator
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Clinical research and clinical trial management form the backbone of drug and device approvals worldwide. Learn from the leading industry experts to build and advance your clinical research career. You'll hear from sponsors, clinical research organizations, and clinical trial sites around the globe. This show is for all current and aspiring clinical research professionals including clinical research associates (CRA), clinical operations managers, study managers, biostatisticians, medical doc ...
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The Australian Prescriber Podcast provides a regular dive into some of the many great articles that Australian Prescriber publishes every two months. In each episode, our host will chat with one of the authors from a recent issue of Australian Prescriber.
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Revenera experts are joined by industry leaders for discussions on all the latest talking points in the world of software.
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The Association for the Advancement of Medical Instrumentation Podcast - AAMI
Association for the Advancement of Medical Instrumentation
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The Association for the Advancement of Medical Instrumentation (AAMI) is developing a series of podcasts in partnership with the studios of Healthcare Tech Talk. The podcasts will explore today's most pressing healthcare technology challenges and the multidisciplinary approaches that are being used to clarify and resolve them. Terry Baker and Kelley Hill, along with renowned subject matter experts, discuss everything from how different technology is developed, implemented, used and maintaine ...
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Compliance Conversations is a monthly podcast for healthcare professionals and compliance officers who want to stay on top of the compliance game. Host CJ Wolf has in-depth conversations with industry experts to explore the riddles and complexities of the compliance world. Wolf chats with fellow compliance experts, auditors, physicians and government officials. Compliance Conversations is produced by Healthicity.
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Presented by Kymanox, Life Science Solutions is dedicated to accelerating understanding and advancing expertise in the life sciences industry. Focused on bringing industry insights to light, our podcast offers a platform where regulatory, scientific, and engineering experts share practical knowledge on overcoming the challenges of product development and commercialization. Episodes equip listeners with the latest on regulatory updates, market trends, cutting-edge technology, and more. Join u ...
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Each week we interview a company founders, medical researchers, physicians or other healthcare industry experts and hear them talk about the challenges of treating patients in the area of their expertise. We'll also hear about gaps in treatment options, and how cutting-edge research is aiming to fill those gaps, both in the short term and in the far future. Then, we talk to entrepreneurs, venture capitalists and other investors who are paving the way for a new generation of therapies, and wh ...
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ATFAQ – Assistive Technology Frequently Asked Questions
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Cyber Security & Physical Security and Safety Information, Products and Technologies
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Listen to healthcare leaders discuss solution-based collaborative approaches to unleashing the power of medical device data. *Music "Straight" by www.bensound.com
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Host Eugene Borukhovich explores how non-molecular therapies and interventions can prevent, manage or even cure diseases. Learn about the rapidly evolving field of Digital Therapeutics, its history, the evolving regulatory and reimbursement frameworks, and the trailblazers creating and advancing this industry.
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Let's build wealth together. Discovering Multifamily features former NFL Fullback Brian Leonard & Anthony Scandariato of Red Knight Properties and is designed to discuss gaining financial freedom through multi-family real estate investing. Here, we interview investors, entrepreneurs, mentors and industry gurus, who educate the audience by sharing experiences in the real estate industry and advice on building wealth.
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Hundreds of thousands of researchers around the world are working to improve life and address imminent threats to humanity. Often, the research ends up in the “Scientific valley of death” in the form of publications and patents that never see the light of the day. Welcome to “Lab to Startup” a podcast aimed at showcasing the effort needed to translate lab research to startups. The show has two main goals: 1. Sharing the stories of those scientists and engineers who have successfully founded ...
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1
The Certificast™ - Eurofins E&E North America
Rick Ostopowicz, Marketing Director, Eurofins E&E North America
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The Certificast™ provides a behind the scenes look at Eurofins E&E North America -- the very first NRTL and a leader in the testing, inspection, and certification industry. Guests and topics range from company information, testing standards, and business best practices. Learn more about Eurofins E&E North America at https://metlabs.com.
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New podcast weblog“AI Revolution in Healthcare: A Regulatory Perspective with Dr. Nirdosh Jagota” is your gateway to understanding the intersection of artificial intelligence and healthcare regulation. Hosted by Dr. Nirdosh Jagota—a seasoned expert with over 30 years in the biotech and pharmaceutical sectors—this podcast explores how AI is reshaping every aspect of healthcare, from drug discovery to patient care, and the regulatory frameworks that support this transformation. In each episode ...
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In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical…
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Sal Tirabassi: Unlocking the Power of Fractional CFO Services
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In this conversation, Jeremy Rivera and Sal Tirabassi discuss the role of fractional CFO services in modern businesses, particularly in the context of remote work and digital transformation. Sal explains how fractional CFOs provide high-quality financial strategy services to emerging businesses, emphasizing the flexibility and cost-effectiveness of…
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1
John Cousins: How to Use AI and Automation to Your Benefit
1:21:53
1:21:53
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In this conversation, John Cousins shares his journey from being an engineer to becoming a successful entrepreneur and investor. He discusses the challenges of partnerships, the impact of AI on the future of work, and the potential for automation to reshape industries. The conversation emphasizes the importance of adapting to change and leveraging …
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In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is …
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Telehealth Fraud, AI, and Cybersecurity: The Compliance Landscape in 2025
35:34
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Telehealth is revolutionizing healthcare, but with new opportunities come new risks. In this latest episode of Compliance Conversations, host CJ Wolf welcomes healthcare attorney Susan Walberg to discuss: - Common telehealth fraud schemes—and how to spot them - Compliance pitfalls that could cost your organization - The latest regulatory updates fr…
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Live! #86 – PART 2: Medical Device Cybersecurity: Proven Strategies for Connected Devices and SaMD
1:13:28
1:13:28
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This panel was recorded 30 January 2025.Please join us live in the future and have your own questions answered! You can sign up for these events and see other resources in the Knowledge Center at RQMplus.com. As software and connectivity reshape MedTech, implementing effective cybersecurity measures has become business-critical. Join part two of…
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Dr. Andy Neillie - Manager vs. Leader: Which One Are You REALLY?
48:19
48:19
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In this conversation, Abbey Crane and Dr. Andy Neillie explore the key differences between managers and leaders. Dr. Andy shares insights from his journey into leadership, emphasizing the importance of passion, character, and competence. They discuss the challenges new managers face, especially in today’s evolving workplace, and how leaders must ad…
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Why 55% of Clinical Trials Fail – The Truth About Drug Development
43:51
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Have you ever wondered why so many clinical trials fail before reaching the market? In this episode, we dive deep into the hidden challenges of clinical trials with Rob Freishtat, President and Co-Founder of Uncommon Cures and a professor at George Washington University School of Medicine and Health Sciences. Rob shares insider knowledge on why ove…
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175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau
39:49
39:49
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🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this…
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The predictive power of biomarkers with Mark Roskey, CSO of Quanterix
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As more preventative approaches to health are set to take center stage, some diseases can’t be prevented but can be managed more proactively. Blood-based biomarkers, such as p-tau217, hold great promise for earlier, more proactive detection and monitoring of diseases such as Alzheimer’s, and it’s here that Quanterix plays a critical role. Their Sim…
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Essential Infrastructure Solutions for Life Sciences Manufacturing and Supply Chain Workflows - with Kartik Pant and Shreyas Becker of Sanofi
21:43
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Today’s guests are two senior executives from Sanofi’s manufacturing division, Head of Data & AI for Manufacturing & Supply Chain Kartik Pant and Head of AI & Data Products, Manufacturing & Supply Shreyas Becker, respectively. Together they return to the podcast to cover the challenges and opportunities in adopting data infrastructure and AI soluti…
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Téa Phillips: Innovating in medical devices & leveraging failure for success
25:13
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SEO book author Jeremy Rivera interviews Téa Phillips, the founder of ATS Innovations and inventor of the Metaflex glove, designed to help individuals manage arthritis and other hand conditions. Téa shares her journey from concept to market, discussing the challenges of product development, regulatory hurdles, and her strategies for marketing and d…
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David Liew talks to Claire Larter, a medical officer at the pharmacovigilance branch of the TGA, about her paper on adverse event reporting. Claire explains why pharmacovigilance is important for clinicians, and outlines what type of adverse events should be reported. The conversation also covers the process of reporting adverse events and how the …
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Owen McCarthy: Bringing a Medical Device to Market, Picking the Right Investors, Partnering with PIs
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In this episode of Building The Future Of, I'm speaking with Owen McCarthy, Co-Founder and President of Medrhythms. Medrhythms offers a medical device called InTandem that helps adults with chronic stroke improve their walking ability. InTandem is based on Rhythmic Auditory Stimulation, an intervention that uses music to drive coordinated movements…
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Next Level Idea with Jacob McLaughlin Founder New to Medical Device Sales
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On this episode of the Next Level Idea podcast we have the honor of speaking with Jacob McLaughlin who is the Founder of New to Medical Device Sales. Jacob talks about his entrepreneurial journey, as well as his start in his own medical device sales career. He shares so much value on how someone can find a new career in medical device sales, and wh…
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Medboard EU EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf EUDAMED EMDN: UPDATE or not to UPDATE – …
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Julian Lotz is cofounder and CEO of BIOVOX a german start-up focused on making medical grade plastics more sustainable. He is an expert for sustainable medical grades and especially for biobased grades. In our discussion Julian elaborates on enivornmental impacts, the difference between biobased and biodegradable and on how to make the future of he…
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174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin
23:57
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🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. Ben Loc…
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Reducing Costs and Improving CX with Hyperautomation - with Paul Cuglietta of Simplyhealth
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Today’s guest is Paul Cuglietta, Head of Contact and Claims at Simplyhealth. Simplyhealth is a health insurance provider based in the UK whose history goes back to the late 1800s. Paul joins today’s discussion to unpack the challenges organizations face when driving digital transformation. With nearly two years of AI integration experience, Paul pr…
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Managing End Point Storage in Hybrid Data Strategies for Financial Services - with Yonas Yohannes of Oracle
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Today’s guest is Yonas Yohannes, CTO of FinTech and FIS at Oracle. An accomplished executive and author, Yonas joins us on today’s podcast to explain the evolving role of endpoint storage for driving new AI capabilities at the edge. He breaks down AI’s true value beyond the marketing hype, and its broader impact on infrastructure across industries,…
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AI Risk Management and Governance Strategies for the Future - with Duncan Cass-Beggs of Center for International Governance Innovation
1:17:40
1:17:40
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Today’s guest is Duncan Cass-Beggs, Executive Director of the Global AI Risks Initiative at the Center for International Governance Innovation (CIGI). He joins Emerj CEO and Head of Research Daniel Faggella to explore the pressing challenges and opportunities surrounding Artificial General Intelligence (AGI) governance on a global scale. This is a …
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What DOJ and FDA Are Looking For in Compliance Programs
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Join CJ Wolf as he sits down with Clint Narver, a former DOJ prosecutor and healthcare compliance expert, to explore best practices, emerging trends, and real-world strategies for avoiding legal pitfalls. Highlights: - Learn how to safeguard your organization against research fraud. - Insights into the DOJ’s perspective on compliance programs. - Re…
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A Blueprint for AI-Driven Process Optimization for Regulated Industries - with Vrinda Khurjekar and Paul Pallath at Searce
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Today’s guests are Vrinda Khurjekar and Paul Pallath, VP of North Americas and Applied AI Lead, respectively, at Searce. Searce is a cloud computing solutions and technology services provider globally that specializes in Cloud, AI, and Analytics. Vrinda and Paul join us today to explore how regulated industries such as financial services and health…
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173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's
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🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this…
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Driving Automated Workflows & Accelerating Drug Development with AI-Powered Trials - with Michelle Longmire of Medable
22:23
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Today’s guest is Michelle Longmire, Co-founder and CEO of Medable. Medable is a platform technology company that accelerates drug development by improving evidence generation in clinical trials. Michelle joins us on the show today to explore how AI is transforming the clinical trial experience for patients, sites, and sponsors from start to finish.…
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Stephanie Hayes: Why You Should Be Thinking About Your Exit Strategy
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In this episode of Unscripted Small Business, Abbey Crane interviews Stephanie Hayes, an acquisition entrepreneur and business strategist/coach. They discuss the often-overlooked topic of exit strategies for entrepreneurs, emphasizing the importance of aligning business models with personal values and understanding the various types of business ass…
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Fraud Risk Solutions for Retail Experiences in Grocery, Banking, and Beyond - with Vivek Khindria of Loblaw
21:07
21:07
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Today’s guest is Vivek Khindria, Former SVP Cyber Security, Network and Technology Risk at Loblaw Companies Ltd., Canada’s largest food retailer. With its operations spanning grocery, pharmacy, banking, and apparel, Loblaw faces unique and multifaceted fraud challenges across diverse verticals. Vivek offers expert insights into the evolving fraud l…
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Helping Electronics Manufacturers Buy and Sell Excess Parts - Margaret Upshur (Founder, Mobius Materials)
21:42
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In this episode of Building The Future Of, I'm speaking with Margaret Upshur, founder and CEO of Mobius Materials. Mobius is a marketplace to directly buy and sell excess electronic components, helping manufacturers save 10-70% off common parts, get access to rare stock and reduce waste. The company was founded in 2021. Check out Mobius: https://mo…
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Prioritising shared decision making, remission from type 2 diabetes, gefapixant for cough
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In this podcast recorded in early January, David Phizackerley provides a brief overview of the February 2025 issue of DTB. The editorial discusses the importance of shared decision making and calls on guideline developers to produce patient decision aids to accompany their guidance - https://dtb.bmj.com/content/63/2/18. A DTB Select item summarises…
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In this episode of RCA Radio®, host Brandon Miller is joined by Rod Mell, Executive Head – Life Science Consulting at RCA, as well as Jordan Elder, Director of Regulatory both at Regulatory Compliance Associates. We explore possible changes in the Medical Device industry in 2025 and provide you with insight on how to prepare yourself for these upco…
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NIST Cybersecurity Framework for Nonprofits | Shaun St.Hill
10:19
10:19
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This episode was created in Notebook LM using a NIST based cybersecurity framework I created that focuses on nonprofits. This document outlines a cybersecurity framework for nonprofits, based on the NIST framework. It prioritizes the protection of various data types (member, donor, employee) and assets, emphasizing cybersecurity training and insura…
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Overcoming Barriers to AI Adoption in Telecom and Beyond - with Moutie Wali of TELUS
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Today’s guest is Moutie Wali, Director of Integrated Planning & Digital Transformation at TELUS. As a leading Canadian telecommunications company, TELUS offers a wide range of products and services, including internet access, voice, entertainment, healthcare, video, smart home automation, and IPTV television. Moutie joins us on today’s show to delv…
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Understanding AGI Alignment Challenges and Solutions - with Eliezer Yudkowsky of the Machine Intelligence Research Institute
43:03
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Today’s episode is a special addition to our AI Futures series, featuring a special sneak peek at an upcoming episode of our Trajectory podcast with guest Eliezer Yudkowsky, AI researcher, founder, and research fellow at the Machine Intelligence Research Institute. Eliezer joins Emerj CEO and Head of Research Daniel Faggella to discuss the governan…
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In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you. Who is Adam Isaacs Rae? Chartered quality…
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In this episode of RCA Radio®, host Brandon Miller is joined by Anita Michael, Executive Pharma Compliance Expert & Principal Consultant and Rona LeBlanc-Rivera, Director, Regulatory Affairs both at Regulatory Compliance Associates®. We explore possible changes in the Pharmaceutical industry in 2025 and provide you with insight on how to prepare yo…
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172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead
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🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this…
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Driving Automation Throughout Insurance, from a Tech-First Perspective - with Tim Nguyen of Cloud Insurance
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Today’s guest is Tim Nguyen, CEO of Cloud Insurance. Cloud Insurance is a seamless and user-friendly SaaS solution made by insurance experts for insurance companies, MGAs, agents, and brokers since 2016. Tim joins the podcast to discuss the critical challenges and opportunities facing SaaS insurance leaders in their digital transformation efforts. …
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Disruptive Trends in Drug and Device Development, with Kymanox President Evan Edwards
22:22
22:22
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22:22
In this episode of Life Science Solutions, Evan Edwards, President of Kymanox, explores the key trends shaping the life sciences industry in 2025. From groundbreaking advancements in cell and gene therapies to the rise of GLP-1 drugs and the essential scaling of CDMO operations, Evan highlights the innovations driving product development and commer…
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AI Regulation and Risk Management in 2024 - with Micheal Berger of Munich Re
21:16
21:16
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21:16
Today’s guest is Michael Berger, Head of Insure AI at Munich Re. Michael returns to the Emerj podcast platform to discuss the evolving landscape of AI risk management and governance. Since his last appearance in 2022, generative AI has shifted from niche discussions to widespread adoption, bringing both opportunities and challenges. Throughout toda…
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S4E01: "The Importance of Cultural Agility in Leadership" with Carlo Argiolas, Sr Business Director Peripheral Vascular Health, Western Europe at Medtronic
38:06
38:06
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38:06
In this episode of The Leadership Consultation, we had the pleasure to welcome Carlo Argiolas, Senior Business Director Peripheral Vascular Health, Western Europe at Medtronic for a compelling discussion on leadership, cultural adaptability, and career growth. Carlo shares his experiences leading multicultural teams, emphasizing the importance of a…
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E180 - Diagnosis and management of antiphospholipid syndrome
16:15
16:15
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Laura Beaton chats with Paul Kubler, director of Rheumatology at Royal Brisbane and Women’s hospital, about how to identify and manage antiphospholipid syndrome. They discuss the key presentations of APS, classification criteria and approaches to treatment. They also cover patients with catastrophic APS and asymptomatic people with persistent antip…
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John David Graham: The Power of Second Chances
52:51
52:51
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52:51
In this episode of the Unscripted Small Business Podcast, Abbey Crane interviews John David Graham, founder of Good Samaritan Home. John shares his remarkable journey from a series of career changes to establishing a nonprofit that provides housing for homeless individuals and ex-offenders. He discusses the challenges of expanding their mission, ov…
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Beyond the Deal: Compliance Lessons for Healthcare Transactions
32:49
32:49
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Selling or acquiring a healthcare practice is no small feat. Regulatory compliance challenges, from Stark Law violations to billing audits, can derail even the best-planned transactions. In this insightful episode of Compliance Conversations, CJ Wolf interviews Ericka Adler, a leading healthcare attorney and Shareholder at Roetzel & Andress, to unc…
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In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow. Who is Joan D’Souza? I have experience in pharmacovigilance, regul…
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Driving Procurement Efficiencies for Oil & Gas - with Faraz Shahid of Cheniere Energy
26:54
26:54
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Today’s guest is Faraz Shahid, Supply Chain Center of Excellence Lead at Cheniere Energy. Cheniere Energy is an American liquefied natural gas company headquartered in Houston, Texas. From automation to predictive AI, Faraz shares his perspective on how technology is reshaping procurement processes to drive efficiency and address industry challenge…
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Using AI to Revive The Art of Product Management with Grant Elliott of SimplAI
45:29
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Today's episode finds us speaking with my good friend, Grant Elliott. Grant will be sharing his background and the new venture he's working on, SimplAI Product. SimplAI Product (pronounced “Simply Product”) integrates advanced AI into each critical phase of product development, simplifying and streamlining processes from concept through to launch a…
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171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products?
7:59
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In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination produ…
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