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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Welcome to FinTalk, the leading podcast in RegTech and FinTech. Join host Jawad Akhtar, a seasoned regulatory consultant with a passion for creating efficient solutions in the evolving world of finance. Get ready for insightful conversations with industry experts and collective wisdom from panel episodes, all packed with cutting-edge insights from VERMEG. Stay ahead of the game with discussions on hot topics, regulatory issues, and the future of finance. With over 20 years of trusted transfo ...
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Dispensing Cannabis business knowledge beyond a million square feet of cultivation space. Blunt Business will navigate the challenges and opportunities of one of the most profitable industries on earth. Join us each episode to hear our weekly round tables and interviews with industry professionals.
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With the effective CAPA management system, you can resolve quality issues, improve customer satisfaction, ensure the compliance with the standards and regulatory requirements, identify and implement improvements. CAPA management software of Qualityze helps the manufacturers to integrate with the other processes that consists of the audit, nonconformance, document management, change control and also the customer responses. Read more - https://www.qualityze.com/capa-management/
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“Follow the Money” with Kevin Sullivan, CAMS, CCI retired State & Federal Money Laundering Investigator. C-Notes podcasts provide listeners with Anti Money Laundering (AML) / Bank Secrecy Act (BSA) training & advisory tips. Topics span the fundamentals of the 5 pillars of a quality AML program through to best practices for AML compliance, risk mitigation, terrorist activity prevention, and financial crime investigation methods & tools available within various industries and to law enforcemen ...
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Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
30:47
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🤔 Struggling with patient recruitment for your medical device clinical studies? Join RQM+ Clinical Trials COO David Novotny and THREAD CEO John Reites as they explore innovative hybrid study approaches to accelerate patient recruitment in MedTech research. In this conversation, you'll learn how hybrid approaches can: Expand your recruitment reach b…
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Key Aspects of Medical Device Clinical Trial Design (1/2) - MedTech CRO: Strategy Development Series
12:47
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ✏️ 𝗞𝗲𝘆 𝗔𝘀𝗽𝗲𝗰𝘁𝘀 𝗼𝗳 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹 𝗗𝗲𝘀𝗶𝗴𝗻 (𝟭/𝟮) Cari Kn…
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Risk Management In Clinical Trials - MedTech CRO: Strategy Development Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🛡️ 𝗥𝗶𝘀𝗸 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 Senior Director of Clinical Oper…
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Beniznga Miami 2024 On Location: Matt Hawkins with Entourage Effect Capital | Rick Cytrynbaum and Christian Hegeseth with VIST Labs
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More of Blunt Business, recorded live from the floor of Benzinga Miami 2024. We hear from three key figures in the cannabis investment space: Matt Hawkins, Managing Partner at Entourage Effect Capital, a leading private equity firm focused on the cannabis industry. Matt shares his expert perspective on the current investment landscape, discussing e…
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Would you like to get reimbursed? – MedTech CRO: Strategy Development Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 💰 𝗪𝗼𝘂𝗹𝗱 𝘆𝗼𝘂 𝗹𝗶𝗸𝗲 𝘁𝗼 𝗴𝗲𝘁 𝗿𝗲𝗶𝗺𝗯𝘂𝗿𝘀𝗲𝗱? Securing regulatory approval is just…
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Tactics for Global Pivotal Studies – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🌍 Our educational video series on clinical trials continues today with 𝗧𝗮𝗰…
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Beniznga Miami 2024 On Location: Kyle Sherman with Flowhub | Jeffrey Trappe,with Planet 13 Holdings, Inc.
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Blunt Business is on location at Benzinga Miami 2024. In this episode, we sit down with Kyle Sherman, CEO of Flowhub, and Jeffrey Trappe from Planet 13 for exclusive conversations about the future of the cannabis industry. Kyle Sherman shares his insights on the evolving landscape of cannabis technology, discussing how Flowhub is empowering dispens…
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Strategy for Global Pivotal Studies – MedTech CRO: Strategy Development Series
17:29
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* 🔍 Strategy for Global Pivotal Studies 🌍 Ever wondered what it takes to ensur…
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The challenges and Solutions in SME Lending
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By VERMEG
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Cannabis Rescheduling Implications for International Trade and Industrywide
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Kevin Williams & Craig Small, Attorneys at Clark Hill, discussed the recent changes in the classification of cannabis and their implications for international trade and the cannabis industry. Kevin clarified his expertise on importing and exporting of cannabis accessories, while Craig, based in Colorado, offered insights on other areas of cannabis …
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Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ❓ How do you effectively 𝗲𝘅𝗲𝗰𝘂𝘁𝗲 first-in-human clinical studies? ❓ What 𝘁𝗮𝗰…
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Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮…
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Live! #79 – FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut
1:09:44
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This was recorded 6 June 2024. We encourage you to download the presentation slides by completing the form on this page. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can s…
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Cannabis Investment Opportunities, and Regulatory Hurdles with Anthony Coniglio
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We discuss cannabis investment opportunities, and regulatory hurdles with New Lake Capital Partners. CEO Anthony Coniglio, Anthony highlighted the importance of cash flow, cost reduction, and operational efficiency in navigating challenges and seizing growth opportunities. We also discuss the potential for individual investors pre-institutional ent…
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Strategy for First-in-Human Studies (1/2) – MedTech CRO: Strategy Development Series
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*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please reach out to RQM+ if you need support with clinical trials.* ❓ What are the objectives and benefits of conducting 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? Wha…
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How Basel 3.1 is Transforming Regulatory Reporting in Banking
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Welcome to FinTalk by Vermeg, the leading podcast in the financial services industry that addresses the most pressing topics in the regulatory reporting and regtech sectors. In this episode, our host Jawad Akhtar is joined by renowned industry experts Andrew and Steve. Together, they delve into the intricacies of Basel 3.1 regulations and their sig…
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Teaser: Introducing Our Clinical Trials Educational Video Series
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🎓 𝗜𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝗶𝗻𝗴 𝗼𝘂𝗿 𝗻𝗲𝘄 𝗲𝗱𝘂𝗰𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝘃𝗶𝗱𝗲𝗼 𝘀𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀. Our VP of Global Regulatory Affairs, Jaishankar Kutty, Ph.D., welcomes you to a free series designed to share our wealth of knowledge and best practices in clinical trial strategy, execution, and regulatory expertise. 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗶𝘀 𝘀𝗲𝗿𝗶𝗲𝘀: ✨ In-depth insights from industry expe…
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Legal Challenges in New York and New Jersey with Robert M. DiPisa
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Robert M. DiPisa from Cole Schotz discusses recent developments in the cannabis industry in New York and New Jersey, with a focus on concerns about third-party advertising leading to consumer confusion. Legal challenges such as Leafly litigation and supply chain issues due to licensing delays were discussed. Additionally, insights were shared on pr…
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Navigating Diverse Markets: Investing Insights with Will McDonough
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We dive into the world of investment with Will McDonough, a titan in the financial industry and co-founder of Nancan Companies, as well as Chairman and Founder of Corestone Capital. With a track record spanning across continents and sectors, McDonough's insights are invaluable. In this episode, we explore McDonough's journey through the financial i…
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Shaping Finance: The Role of RegTech, AI, and Data Quality
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Welcome to FinTalk by Vermeg, the leading podcast in financial services that addresses the most pressing topics in the financial services industry. In this episode, our host Jawad Akhtar is joined by renowned RegTech expert James Phillips. Together, they delve into how technological innovations and regulatory changes are reshaping the financial ser…
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Florida's Adult Use Cannabis Legalization and Amendment 3
55:36
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Matthew Ginder, Partner in the Cannabis Law practice group at Greenspoon Marder talks about Florida's adult use cannabis legalization, with a focus on achieving voter approval for Amendment Three in 2024. Matt Ginder and Brasco debated THC restrictions, consumption locations, and industry support, highlighting concerns about opposition from healthc…
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Scott Edwards, Managing Director | Excellence Spotlight
13:57
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. "Encouraging and driving a strong culture of quality allows a company to effectively manage the details in a collaborative way…
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Vaping Safety Measures, Regulatory Challenges, and Quality Assurance with ISO and GMP
38:22
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Blunt Business welcomes Michael Wang, Co-CEO and CFO with ISPIRE, a company specializing in e-cigarettes and cannabis vaping products. Discussions included collaborations with Hidden Hills, new device launches like Switch One, and partnerships with Burna Boy. Safety measures, regulatory challenges, and quality assurance with ISO and GMP certificati…
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"Safe Harbor Financial's Strategic Success: Sundie Seefried Shares Solutions and Strategies for Cannabis Business Bliss"
39:26
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Blunt Business welcomes Sundie Seefried, CEO, Safe Harbor Financial to talk about Safe Harbor Financial's recent operations and future plans. Seefried highlights the company's successful earnings call, showcasing an 85.3% revenue increase in 2023 and strategic moves to expand services and launch new lending products. We delve into topics such as li…
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Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan
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This show was recorded 25 April 2024. We encourage you to download the IVDR timeline presented at the beginning of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events …
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FDA Releases Final Rule on Laboratory-Developed Tests (LDTs): What You Need to Know | MedTech Voices
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𝗡𝗘𝗪𝗦 → FDA releases final rule on Laboratory-Developed Tests (LDTs) 🚨 RQM+'s Bethany Knorr Chung, PhD, RAC and Margot Borgel, Ph.D. dive into the details of what you need to know, including: ✅ The 4-year phase-in timeline for compliance ✅ Expanded enforcement discretion for certain LDTs ✅ Grandfathering clause for currently marketed LDTs Watch now …
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Exploring Financial Crime Risk Assessment and the Evolving Landscape
19:58
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Welcome to FinTalk, the leading podcast in regulatory compliance and financial services that addresses the most pressing topics in the industry. In this episode, our host Jawad Akhtar is joined by Jessica Cath from Thistle Initiatives. Together, they talk about the world of financial crime prevention, regulatory compliance, and the evolving regulat…
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Samantha Howard, Study Director (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Hot on the heels of Jordi Labs' groundbreaking new publication support for simulated use testing of blood-contacting medical…
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Minnesota Adult Use Cannabis Plan Examined with Sara Gullickson
53:06
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Sara Gullickson, Founder and CEO from CB Advisors offers a sneak peek into her upcoming presentation at the Lucky Leaf Expo, where she will unveil strategies for executing operational plans for a successful cannabis launch in Minnesota. As the state gears up to join the ranks of legalized cannabis territories, her expertise promises to shed light o…
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Noel Keegan on Clinical Data Management | Excellence Spotlight Bonus
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In this special bonus clip from our Excellence Spotlight series, Sr. Director of Data Operations (Clinical Trials) Noel Keegan takes a deep dive into clinical data management. From the transition to electronic systems to the exciting potential of AI, Noel reflects on the evolution he's witnessed over his 16+ year career. He breaks down the key aspe…
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Standardizing Laboratory Practices in the Cannabis iFor Accurate Testing
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Blunt Business discusses standardizing laboratory practices in the cannabis industry for accurate testing. We welcome Breanna Neff, Founder and Chief Food Scientist at brelixi, who shares insights on vetting labs for data integrity. Breanna introduced brelixi's products like THC/CBD powders for fast-acting functional solutions in daily life. NFL-fu…
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Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year Career
19:44
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While we believe you will find Nancy's story and advice inspiring without visuals, we encourage you to watch the video version containing a brief presentation on the RQM+ website here. In this heartfelt and insightful video presentation, now available on our blog, Nancy Morrison, RAC shares her journey and the lessons she's learned along the way. N…
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On the Current State of the Canadian Cannabis Market
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Blunt Business welcomes the CEO of Motif Labs Founder Mario Naric. We discuss the current state of the Canadian cannabis market, with Mario sharing insights on Motif Labs' success in the vapes and infused pre-rolls market. We highlight the significance of the upcoming review of the 2018 Cannabis Act, while later discussing the ongoing review of the…
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Live! #77 – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
55:26
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This show was recorded 28 March 2024. We encourage you to download the presentation given in the first portion of this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages a…
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Sew-Wah-Tay, Vice President of Strategic Regulatory Affairs | Excellence Spotlight
14:50
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Our Excellence Spotlight interview series celebrates and showcases the remarkable journeys and achievements of RQM+ employees. These employees are committed to technical excellence and make significant positive contributions to our clients' success. In our newest interview, we're thrilled to showcase Vice President of Strategic Regulatory Affairs, …
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Assessing Biden Administration Attempts for Cannabis Reform
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We continue our discussion with Cat Packer, Director of Drug Markets and Legal Regulation, Drug Policy Alliance about the Biden Administration's proposal to reschedule cannabis from schedule one to schedule three under the Controlled Substances Act, arguing that while this move is significant, it falls short of the promise of decriminalization made…
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How does a notified body clinical reviewer approach a review? | MedTech Voices
13:06
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RQM+ Vice President of Global Regulatory Affairs (and former BSI), Jaishankar Kutty, Ph.D., discusses the process of reviewing clinical evaluation reports (CERs) by notified body reviewers under the EU MDR in our newest video clip. In the end and more than anything, manufacturers must provide a clear and comprehensive story in their CERs to facilit…
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A Comprehensive Approach to Cannabis Policy Reform
38:05
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Cat Packer, Director of Drug Markets and Legal Regulation, Drug Policy Alliance joins Blunt Business for a 2-part interview where we first discuss the need for a comprehensive approach to cannabis policy reform that prioritizes social equity and harm reduction. We talk about the importance of addressing social equity concerns, such as the concentra…
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Adam Eason, Senior Study Director (Jordi Labs) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🧪 With a fascinating career spanning drug development with GSK to addressing ESPN's water issues, RQM+ / Jordi Labs Senior Stu…
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Embracing Diversity and Inclusion in Financial Services #S3EP5
24:28
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Welcome to FinTalk by Vermeg, the leading podcast in financial services that addresses the most pressing topics in the regulatory reporting and Regtech industry. In this episode, our host Jawad Akhtar is joined by renowned industry expert Kasia. Together, they delve into the significance of diversity and inclusion in the workplace and how it can le…
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Noel Keegan, Sr. Director, Data Operations (Clinical Trials) | Excellence Spotlight
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Our newest Excellence Spotlight interview is with Noel Keegan, a central figure in RQM+ clinical trial services. Noel is Sr. D…
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Cannabis Licensing and Regulatory Compliance Challenges and Opportunities
50:44
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Paula Savchenko, Esq. Founder, Cannacore Group discusses cannabis licensing and regulatory compliance and the challenges and opportunities therein. Advertising Inquiries: https://redcircle.com/brands Privacy & Opt-Out: https://redcircle.com/privacyBy Cannabis Radio
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Kaitlin Lerner, Director of Operations, Lab Services (Jordi Labs) | Excellence Spotlight
11:25
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Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. 🔬 Kaitlin Lerner is "that chemist" with a Gibbs free energy tattoo. As Director of Operations, she's also one of the most bril…
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Current State of Cannabis Legalization and Industry Development
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Robert Hoban, Chair, Cannabis Practice, Clark Hill discusses the current state of cannabis legalization and industry development. We also discuss recent halts in licensing due to court decisions and Robert sharing his firm's expansion into the European Union. We also highlight discussed difficulties faced in New York's licensing process, challenges…
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Welcome to FinTalk by Vermeg, the go-to podcast for financial services that tackles the biggest issues in finance. In this episode, our host Jawad Akhtar welcomes Michael Lawrence from Bovill, a top expert in the field. They talk about the nitty-gritty of Consumer Duty and what it means after the July 2023 deadline. They'll also look at how the FCA…
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1
Payment Solutions and Loyalty Programs to Drive Cannabis Industry growth.
50:25
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Blunt Business welcomes Jeffrey Harris, the CEO of springbig to discuss the importance of loyalty programs in the cannabis industry, We follow up on Springbig's growth and expansion to over 3000 retail locations. We also look into the challenges and opportunities in the industry, including investment strategies, regulatory changes, and tax benefits…
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Anastassia Young, Senior Consultant | Excellence Spotlight
11:04
11:04
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11:04
Our Excellence Spotlight series celebrates and showcases the remarkable journeys and achievements of RQM+ employees; the same employees who are committed to technical excellence and make a significant impact on our clients. Yesterday, we published a clip of RQM+ Senior Consultant Anastassia Young, MS discussing our recent conversation with the FDA …
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Streamlining AE Reporting in PMCF Studies (FDA Perspective) | MedTech Voices
8:45
8:45
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8:45
Are you navigating adverse event (AE) reporting in post-market clinical follow-up (PMCF) studies? In a recent discussion with the FDA, we've uncovered valuable insights into exemptions and variances for AE reporting that could significantly reduce your reporting burden. This collaboration between RQM+ and the FDA paves the way for a more efficient …
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Live! #76 – MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices
59:28
59:28
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59:28
This show was recorded 22 February 2024. We encourage you to download the supplemental PDF content for this session by completing the form on this page. Please join us live for future shows and ask your own questions! We hold one RQM+ Live! panel discussion per month and you can sign up at the Knowledge Center or Events pages at RQMplus.com. Th…
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Building Celebrity Cannabis Brands with Iconic Celebrity Figures
48:57
48:57
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48:57
Adam Wilks, CEO of Carma HoldCo is back on Blunt Business to talk about his work operating his global licensing company behind the nation’s fastest-growing celebrity brands, working with icons like Mike Tyson (Tyson 2.0), Ric Flair (Ric Flair Drip and Wooo Energy drinks), Future (EVOL) and Hulk Hogan (Immortal) to turn their cannabis brands into lu…
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