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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Bryan and Kellan are curious learners, who explore the creative strategies of entrepreneurs pioneering the cannabis industry, projected to reach a $100 billion valuation by 2023. Each week, we dive into guests' journeys, from CEOs of publicly traded giants and world-renowned scientists to underground legacy growers shaping the industry. Discover how they found their place in Cannabis, their original business plans, and the pivots and perseverance needed to navigate cannabis-specific challeng ...
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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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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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Light, Yield, and Quality: The Science Behind Cannabis Cultivation with Travis Higginbothman
53:26
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Growing cannabis is like navigating a path in many directions. Are you cultivating for smokable flowers or extract? How do you take a skill once passed down from person to person and translate that into high-end cultivation practices that can be standardized across employees or even scaled across companies? These skills demand a unique blend of rig…
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Tommy Kumlin, Chemist I (Jordi Labs) | Excellence Spotlight
6:43
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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 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 short interview series continues this week, as Christine Santagate, RAC is joined by another memb…
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How Samsung Biologics Achieved 16 Top Pharma Partnerships as a CDMO
43:15
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Welcome to episode 061 of Life Sciences 360. In this episode of Life Sciences 360, host Harsh Thakkar sits down with Kevin Sharp, Senior Vice President and Head of Global Sales at Samsung Biologics. They dive deep into the evolving CDMO industry, the importance of agility, innovation, and the strategic growth pillars that are driving success at Sam…
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Data Management In Clinical Trials (Maintenance/Closeout) – MedTech CRO: Clinical Trial Execution Series
14:10
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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.* 🎉 The data management party continues! Part 2 of o…
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Under the Hood of Cresco Labs: AI, Tech Integration, and Custom Retail Solutions ft. Zach Marburger
50:01
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Cresco Labs is one of the largest MSOs in the industry, but at its core, it has an entrepreneurial mindset that has always stayed the same. Many overlook that a company with a sizable market cap can still possess the craftiness and perspective of a smaller company. This mindset has led to strategic opportunities that allow Cresco Labs to thrive in …
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Data Management In Clinical Trials (Setup Phase) – MedTech CRO: Clinical Trial Execution Series
14:01
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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.* 🎉 It's a data management party – you in? Our team ha…
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Joshua Nott, Technical Program Lead (Jordi Labs) | Excellence Spotlight
8:33
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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 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗦𝗽𝗼𝘁𝗹𝗶𝗴𝗵𝘁 series of interviews with RQM+ employees returns today as Christine Santagate, RAC is joined by enthu…
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Why the Top 1% are lonely- insights from Dr. Robyn Odegaard
36:17
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Welcome to episode 060 of Life Sciences 360. In this episode of Life Sciences 360, host Harsh Thakkar sits down with Dr. Robin Odegaard, a high-performance business psychologist and professional confidant, to discuss the hidden struggles that come with success. They dive deep into topics like imposter syndrome, self-sabotage, complex priorities, an…
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Emily Sisneros: Kentucky's Hot Medical Market and Winning Cannabis Licenses
48:09
48:09
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Kentucky is now hot on the radar as a prime location for medical cannabis opportunities. As the application window dwindles, we take a detailed look at the potential and challenges within the state's medical market. In this episode, we explore the intricate process of applying for cannabis licenses in Kentucky. Learn what you need to do to be succe…
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The Science Behind Tome’s Programmable Genomic Integration Technology with CSO John Finn
43:30
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Welcome to episode 059 of Life Sciences 360. In this episode of Life Sciences 360, Harsh Thakkar is joined by John Finn, Chief Scientific Officer at Tome Biosciences. John shares his inspiring journey of overcoming challenges, like his stutter, while making groundbreaking strides in gene therapy. They dive deep into Tome’s unique technology, PGI (P…
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Secrets of Site Selection and Monitoring for IVD Studies (Part 2/2) – MedTech CRO: Clinical Trial Execution Series
9:03
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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.* Explore in vitro diagnostic (IVD) clinical trial site …
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Secrets of Site Selection and Monitoring for IVD Studies (Part 1/2) – MedTech CRO: Clinical Trial Execution Series
10:10
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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.* Explore in vitro diagnostic (IVD) clinical trial site se…
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Behind the Scenes of Cannabis Lobbying: How it REALLY Works ft. The Liaison Group
53:13
53:13
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Cannabis reform always feels like it's on the verge of a breakthrough with policy. We know some policies can pass both the House & Senate yet it doesn’t , but it ends up feeling like a pawn in the horse trading by policymakers who all know that ~70% of Americans are in favor of cannabis legalization. So why does policy that has support from both si…
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Live! #81 (with FDA) – Advancing Health Equity with IVDs & Medical Devices
1:06:15
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This presentation and panel was recorded 8 August 2024. We encourage you to download Michelle Tarver's 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 …
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Inside the Lab: How Singota Solutions Leads in Early-Stage Pharma Development
32:25
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Welcome to episode 058 of Life Sciences 360. In this insightful episode of Life Sciences 360, hosted by Harsh Thakkar, we explore the dynamic world of Contract Development and Manufacturing Organizations (CDMOs) with Ryan Memmer, Manager of Quality Control and Product Development at Singota Solutions. Ryan shares his journey from working at large p…
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The Hidden Benefits of Fractional Marketing for Cannabis Companies ft. Brandon Bobart
48:08
48:08
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Successful marketing requires a blend of specialized expertise and a broad understanding of strategic frameworks. However, too often, marketing gets pigeonholed into a single person's role, expecting them to handle everything from strategy to execution. In fast-paced, scaling startups, this is precisely where fractional marketers can make a critica…
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Bioidentical Hormone Replacement: A Deep Dive with Dr. Greg Brannon
38:19
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Welcome to episode 057 of Life Sciences 360. In this special episode of Life Sciences 360, hosted by Harsh Thakkar, we dive into the fascinating world of bioidentical hormone replacement therapy (BHRT) with Dr. Greg Brannon, Medical Director and Founder of Optimalbio. Celebrating National Men's Health Education and Awareness Month, Dr. Brannon shar…
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Tactical Considerations for IVD Clinical Trials – MedTech CRO: Clinical Trial Execution Series
9:58
9:58
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Our ongoing educational video series on 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 covers three areas: ♟️ Strategy 🛠️ Execution ✅ Regulatory Optimize your IVD clinical trials and watch our newest video in the series: 𝗧𝗮𝗰𝘁𝗶𝗰𝗮𝗹 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗳𝗼𝗿 𝗜𝗩𝗗 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀. Director of IVD Global Regulatory Affairs, Margot Borgel, Ph.D., is joined by Senior Director of Clinical Opera…
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Site Monitoring In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
13:05
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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.* 🔄 We recently covered Site Selection In Clinical Trials an…
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How Top Cannabis Companies Keep and Attract Employees ft. Mike Siebold
52:02
52:02
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"Every time a company doubles in size, you need to redo all processes." – Reid Hoffman, founder of LinkedIn. The speed and development of the cannabis industry often conflict with the ability to take a step back and recognize the internal organizational changes that have occurred since the last time you aligned your structure. Are your total compen…
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Site Selection In Clinical Trials – MedTech CRO: Clinical Trial Execution Series
13:04
13:04
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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 newest video: 𝗦𝗶𝘁𝗲 𝗦𝗲𝗹𝗲𝗰𝘁𝗶𝗼𝗻 𝗜𝗻 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀. Senio…
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How Green Elephant Biotech is making labs more sustainable with Joel Eichmann
38:36
38:36
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Welcome to episode 056 of Life Sciences 360. Welcome to another episode of Life Sciences 360! In this episode, Harsh Thakkar is joined by Joel Eichmann, co-founder and managing director of Green Elephant Biotech. Green Elephant Biotech is a trailblazer in the biotech industry, focusing on sustainability and using plant-based materials to create inn…
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Using AI for Effective Digital Transformation in Financial Services
16:47
16:47
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Welcome to FinTalk by Vermeg, the leading podcast in the fintech industry that addresses the most pressing topics in the financial services industry. In this episode, our host Jawad Akhtar is joined by renowned industry expert Zahra Shah. Together, they delve into the intricacies of digital transformation in banking, focusing on legacy banking syst…
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The Cannabis Industry is Exploding: Here's Why You Are Not Optimistic Enough ft Ben Burstein
57:52
57:52
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Cannabis sentiment is not positive enough. Given the challenges and fatigue, it's easy to lose sight of what's happening. Cannabis is being built from the ground up. Regulations and capital may currently hinder some aspects, but what's happening in the industry is undeniable. This week, we sit down with Ben Burstein, who reveals the actual situatio…
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The Future of mRNA Therapies with Dr. Kate Broderick
34:16
34:16
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Welcome to episode 055 of Life Sciences 360. In this episode of Life Sciences 360! In this episode, Harsh sits down with Dr. Kate Broderick, Chief Innovation Officer at Maravai Life Sciences. Dr. Broderick shares her journey from academia to leading innovation in the biotech industry, discusses the pivotal role of Clean Cap technology in COVID-19 v…
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Live! #80 – Beyond EtO: New EPA Regulations and Sterilization Alternatives
47:42
47:42
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This was recorded 18 July 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 ca…
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Rama Mayo: Hall of Flowers, The Big Reveal - Disney World of Cannabis Experiences
50:31
50:31
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Tradeshows are a universal way of connecting with others in a similar industry for a unified reason. However, as costs rise, the value of attending these events is weighed against other efforts. Success at these events varies per individual, adding to the challenges. Rama Mayo and the team at Hall of Flowers already have a must-attend event. This y…
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Navigating Regulatory Landmines for Combination Products – MedTech CRO: Regulatory Expertise Series
14:36
14:36
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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.* While she has moved towards retirement since recording this vi…
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Vector Labs CEO Lisa Sellers on Innovation, Leadership, and Mentorship
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42:57
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Welcome to episode 054 of Life Sciences 360. In this episode of Life Science 360 ,Today, we are thrilled to have Lisa Sellers, the CEO of Vector Labs, as our special guest. Lisa shares her incredible journey from working at big names like Thermo Fisher and 10x Genomics to leading Vector Labs, a trusted manufacturer of reagents and critical componen…
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This conversation features a Q&A session with a CAPA-focused team from RQM+ and explores the unique value consultants bring to clients. Our experienced team shares their top skills, dream projects, and what drives them to make a difference in the industry. From problem-solving strategies to personal inspirations, discover how these professionals ar…
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Strategy & Tactics for Combination Device Clinical Trials – MedTech CRO: Strategy Development Series
19:20
19:20
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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.* Combination Device Clinical Trials: Strategy & Tactics Join RQM+…
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Can CBN Replace Melatonin? Results from a Double-Blind Placebo-Controlled Study ft. Alleh Lindquist
51:37
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While many have found cannabis to be helpful for sleep, is it anecdotal, or is there science to back up these feelings? In the US, 50 to 70 million adults have chronic sleep problems or sleep disorders, according to SleepHealth.org. FloraWorks set out to validate these claims through double-blind placebo trials, employing the rigorous standards use…
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Scientist on Epigenetic Tuning and Future Therapies at Tune Therapeutics
36:52
36:52
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Welcome to episode 053 of Life Sciences 360. In this episode of Life Science 360, our host Harsh Thakkar sits down with Brian Cosgrove, Principal Scientist at Tune Therapeutics. Brian dives deep into the fascinating world of epigenetics and its role in developing therapies for complex diseases. He shares insights on how Tune Therapeutics is leverag…
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Key Aspects of Medical Device Clinical Trial Design (2/2) – MedTech CRO: Strategy Development Series
12:44
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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.* 💡🏥 𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗦𝗲𝗰𝗿𝗲𝘁𝘀 𝗼𝗳 𝗦𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶…
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Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
30:47
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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Breaking Down Barriers in Psychedelic Drug Development
42:22
42:22
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Welcome to episode 052 of Life Sciences 360. In this episode, of Life Sciences as we dive into the fascinating world of psychedelic therapeutics with Dr. Sam Clark, the Chief Executive Officer of Terran Biosciences. Dr. Clark shares his journey of founding Terran Biosciences, motivated by the need for better treatment options for psychiatric and ne…
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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
14:21
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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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Curaleaf's European Breakout & Boris Jordan Strategy for The Hemp Company
29:57
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The lack of guidance from the US Federal Government on the cannabinoid industry poses significant challenges for those involved in the sector. The absence of clear regulations and leadership complicates business operations. In contrast, European countries are both legalizing cannabis and planning further legalization. They are keen to avoid the mis…
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Would you like to get reimbursed? – MedTech CRO: Strategy Development Series
14:24
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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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From Genes to Treatments: Howard McLeod on Precision Medicine
41:14
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Welcome to episode 051 of Life Sciences 360. We welcome Howard McLeod, a distinguished expert in precision medicine and pharmacogenomics. Howard shares his profound journey into the world of personalized medicine, emphasizing the significant impact of individualized treatments on cancer patients. From groundbreaking gene discoveries to advising cut…
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Tactics for Global Pivotal Studies – MedTech CRO: Clinical Trial Execution Series
21:35
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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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Mastering Cannabis Storytelling/How to Talk to Your Kids About Cannabis ft. Jordan Isenstadt
49:31
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49:31
Creating a powerful and emotionally resonant message is essential in the cannabis industry, where many people have unique and personal connections to the plant. Crafting a message that genuinely resonates can yield compounding results. Although PR and marketing often get grouped together, they require distinct strategies to complement each other ef…
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Tony Martignetti on Inspired Leadership, Flashpoints, and Divergent Thinking
42:25
42:25
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42:25
Welcome to episode 050 of Life Sciences 360. In this episode, Harsh Thakkar chats with Tony Martignetti, a top leadership development voice on LinkedIn and an advisor to numerous tech and life sciences executives. Tony shares his insights on inspired leadership, the importance of investing in people, and how to unlock potential within teams. They a…
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Strategy for Global Pivotal Studies – MedTech CRO: Strategy Development Series
17:29
17:29
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17:29
*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
19:39
19:39
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19:39
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 space. In this episode, our host Jawad Akhtar is joined by renowned industry expert Gabriele Sabato, Co-Founder and CEO of Wiserfunding. Together, they explore the challenges and soluti…
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How Grown Rogue's Craft Cannabis Model is Disrupting the Industry ft. Obie Strickler
50:00
50:00
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50:00
What does your business do better than anyone else's? This is your competitive advantage. As we move away from the "growth at all costs" mindset, businesses are doubling down on their strengths—Grown Rogue has emphatically done just that. Battle-tested in highly competitive markets, this high-end cultivator consistently proves its ability to design…
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Tactics for First-in-Human Studies – MedTech CRO: Clinical Trial Execution Series
11:40
11:40
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11:40
*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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Understanding Drug Pricing and the Impact of the Inflation Reduction Act with Jesse Mendelsohn
39:21
39:21
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39:21
Welcome to episode 049 of Life Sciences 360. In this episode of Life Sciences 360, host Harsh Thakkar welcomes Jesse Mendelsohn, Senior Vice President at Model N. Jesse delves into the intricacies of revenue optimization and compliance within the pharmaceutical industry. He shares insights on how Model N's platform aids pharmaceutical companies in …
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Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series
12:59
12:59
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12:59
*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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