๐ ๐๐ป๐๐ฟ๐ผ๐ฑ๐๐ฐ๐ถ๐ป๐ด ๐ผ๐๐ฟ ๐ป๐ฒ๐ ๐ฒ๐ฑ๐๐ฐ๐ฎ๐๐ถ๐ผ๐ป๐ฎ๐น ๐๐ถ๐ฑ๐ฒ๐ผ ๐๐ฒ๐ฟ๐ถ๐ฒ๐ ๐ผ๐ป ๐ฐ๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐. 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. ๐๐ถ๐ด๐ต๐น๐ถ๐ด๐ต๐๐ ๐ผ๐ณ ๐๐ต๐ถ๐ ๐๐ฒ๐ฟ๐ถ๐ฒ๐: โจ In-depth insights from industry experts ๐ ๏ธ Practical tips and best practices ๐ Comprehensive and interactive learning opportunities, including technical briefs, white papers, webinars, and RQM Live! panel discussions ๐จ๐ฝ๐ฐ๐ผ๐บ๐ถ๐ป๐ด ๐๐ถ๐ฑ๐ฒ๐ผ๐ ๐๐ถ๐น๐น ๐ฐ๐ผ๐๐ฒ๐ฟ ๐๐ต๐ฟ๐ฒ๐ฒ ๐ธ๐ฒ๐ ๐ฎ๐ฟ๐ฒ๐ฎ๐: ๐ Clinical trial strategy โ๏ธ Clinical trial execution ๐ Regulatory expertise in clinical trials ๐ฅ๐ค๐ ๐ถ๐ ๐ฎ ๐น๐ฒ๐ฎ๐ฑ๐ถ๐ป๐ด ๐ ๐ฒ๐ฑ๐ง๐ฒ๐ฐ๐ต ๐๐ฅ๐ข, with a legacy spanning 40 years in the industry, and we plan to show you many of the reasons why through this content. Stay tuned to our LinkedIn page in the coming months and feel free to share the news with your networks! We'll be providing as much value as we can. ๐ #ClinicalTrials #MedTech #Education #CRO #MedicalDevices #IVDs #CombinationProducts #RegulatoryAffairs
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Here are vital considerations to ensure your trialโs success: ย 1๏ธโฃ Comprehensive Feasibility Assessment: Thoroughly evaluate regulatory landscape, potential sites and PIs. Assess infrastructure, logistical capabilities, and expertise. Align these elements with your study objectives to ensure a strong foundation. 2๏ธโฃ Ethical and Regulatory Navigation: Craft detailed submissions for IRB/EC and consult with regulatory bodies whenever possible. Stay informed about local and international regulations to ensure compliance and uphold the trialโs integrity. 3๏ธโฃ Contract Negotiations and Collaborative Partnerships: Establish clear roles, responsibilities, and compensation in your contracts. Foster a collaborative spirit to align study goals with those of your partners, building a foundation of trust and respect. 4๏ธโฃ Ensuring Availability of Investigational Products and Study Materials: Develop reliable supply chains and uphold quality assurance standards. This logistical preparation is crucial to keep your trial on track. 5๏ธโฃ Training and Equipping the Team: Provide comprehensive training and regular updates to your team. Ensure protocol proficiency and adaptability to handle challenges, maintaining the trialโs momentum. ย ๐ก Initiating a clinical trial is a complex but rewarding endeavor that advances medical knowledge. By approaching each step with thoroughness, dedication, and collaboration, we lay the foundation for trials that achieve their objectives and pave the way for future medical breakthroughs. ย ๐ If you want expert guidance in managing clinical trials, our team at Axcellant would be committed to delivering the highest quality data efficiently, ensuring your trialโs success from inception to completion. Feel free to contact me directly.ย ๐ ย #CRO #clinicaltrials #medicine #biotech
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Improving Clinical Trial Efficiency for Optimal Results by Julianne Hull Join us for a comprehensive course designed to optimize clinical trial and program delivery. Ideal for professionals in pharma, biotechs, and service providers, this event offers essential strategies for enhancing trial efficiency and achieving optimal results. ๐ Dates: October 2nd - 3rd, 2024 โฐ Time: 9:00 AM โ 12:30 PM EDT (UTC-4) Day 1 Highlights: ย ๐ Understanding the end goals for clinical trials ย ๐ Exploring support systems for optimal trial delivery ย ๐ Utilizing standards for efficient program delivery ย ๐ Optimizing study protocols in alignment with ICH E6 and ICH E8 ย ๐ Strategies for enrolling evaluable patients and maintaining clinical data review Day 2 Highlights: ย ๐ Proportionate risk-based approach for resource allocation ย ๐ Issue management, escalation, and CAPA management ย ๐ Best practices for metrics and performance management ย ๐ Incorporating CROs, technology, and service providers for efficiency ย ๐ Prioritization across clinical trial programs Key Takeaways: ๐ Understanding the importance of end goals in clinical trial efficiency ๐ ๏ธ Confirming regulatory compliance while investing in optimization ๐ Benefits of standardization in clinical trial delivery ๐ก Roles and responsibilities for delivering optimal trials ๐ Data and Data Governance as central to inspection-ready clinical trials Don't miss this opportunity to enhance your clinical trial delivery and ensure optimal results. Secure your spot today! ๐ง Register today: [email protected]ย ๐ Contact us: 1 657 452 8174 #ClinicalTrials #ClinicalTrialEfficiency #PharmaceuticalTraining #Biotech #ClinicalOperations #DataManagement #RegulatoryCompliance #CRO #HealthcareProfessionals #ClinicalResearch #PharmaTraining #LifeSciences #ClinicalDataReview #PatientSafety
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๐ Exciting News! ๐ I'm thrilled to share that I've successfully completed the ๐๐ง๐ญ๐ซ๐จ๐๐ฎ๐๐ญ๐ข๐จ๐ง ๐ญ๐จ ๐๐จ๐จ๐ ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐๐ซ๐๐๐ญ๐ข๐๐ course offered by ๐ก๐ผ๐๐ฎ๐ฟ๐๐ถ๐! ๐๐ฌ ๐ ๐ช๐ต๐ฎ๐'๐ ๐๐ ๐๐น๐น ๐๐ฏ๐ผ๐๐? This ๐-๐ฐ๐๐๐ค ๐๐จ๐ฎ๐ซ๐ฌ๐ delves into the fundamental principles and practices of ๐๐จ๐จ๐ ๐๐ฅ๐ข๐ง๐ข๐๐๐ฅ ๐๐ซ๐๐๐ญ๐ข๐๐ (๐๐๐). As we know, GCP is ๐๐ฌ๐ฌ๐๐ง๐ญ๐ข๐๐ฅ for conducting clinical trials and ensuring the safety and well-being of human subjects. ๐ ๐๐ผ๐๐ฟ๐๐ฒ ๐๐ถ๐ด๐ต๐น๐ถ๐ด๐ต๐๐: - ๐๐๐ฒ ๐๐จ๐ง๐๐๐ฉ๐ญ๐ฌ: Explore the clinical trial process, the basics of good clinical practice, and the history of regulatory frameworks for medical treatment and testing. - ๐๐ซ๐ฎ๐ ๐๐๐ฏ๐๐ฅ๐จ๐ฉ๐ฆ๐๐ง๐ญ: Understand the journey from drug development to clinical trials. - ๐๐๐ ๐ฎ๐ฅ๐๐ญ๐จ๐ซ๐ฒ ๐ ๐ซ๐๐ฆ๐๐ฐ๐จ๐ซ๐ค๐ฌ: Dive into the guidelines and requirements outlined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). ๐ ๐ช๐ต๐ ๐๐๐ฃ ๐ ๐ฎ๐๐๐ฒ๐ฟ๐: Good Clinical Practice ensures the integrity and reliability of clinical trial data. As researchers, we play a crucial role in advancing medical knowledge and improving patient outcomes. Let's continue learning and contributing to the field! ๐ช๐ #ClinicalResearch #ProfessionalDevelopment #LifelongLearning #GCP #NOVARTIS
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๐ฌ Decoding Excellence: Exploring the FDA Form 1572 ๐ฌ In the intricate landscape of pharmaceuticals and clinical research, certain forms wield immense significance, acting as cornerstones of regulatory compliance and scientific integrity. One such form that commands attention is the FDA Form 1572. ๐ Unraveling the Essence: At the heart of every clinical trial lies a commitment to rigorous standards and ethical conduct. The FDA Form 1572 epitomizes this commitment, serving as a solemn declaration of responsibility for investigators engaged in the pursuit of medical advancement. It is a testament to the principles of transparency, accountability, and patient welfare that underpin the entire research endeavor. ๐ A Pact of Integrity: When an investigator signs the FDA Form 1572, they are not merely affixing their signature to a piece of paper; they are affirming their dedication to upholding the highest standards of clinical practice. This form signifies more than just regulatory compliance; it represents a pact of integrity between the investigator, the sponsor, and the regulatory authorities, with patient safety at its core. ๐ Guardian of Trust: In an era where public trust in scientific research is paramount, the FDA Form 1572 serves as a guardian of credibility and trustworthiness. By declaring their commitment to adhering to Good Clinical Practice (GCP) guidelines and regulatory requirements, investigators instill confidence in the validity and reliability of their findings, ensuring that the fruits of their labor serve the greater good. ๐ Catalyst for Innovation: Far from being a bureaucratic hurdle, the FDA Form 1572 catalyzes innovation by fostering an environment of compliance and quality assurance. By setting clear expectations and standards for investigators, it empowers them to conduct research with precision and diligence, thereby accelerating the pace of discovery and bringing life-saving treatments to patients in need. As we navigate the complexities of clinical research, let us not overlook the significance of seemingly mundane forms like the FDA Form 1572. Behind its bureaucratic faรงade lies a profound commitment to scientific excellence, ethical conduct, and the relentless pursuit of knowledge for the betterment of humanity. Let us embrace the spirit of accountability embodied by the FDA Form 1572, recognizing it not as a regulatory burden, but as a beacon of integrity guiding us towards a future where every medical breakthrough is built on a foundation of trust and reliability. #FDA #ClinicalResearch #Ethics #RegulatoryCompliance #Innovation #PatientWelfare #FDAForm1572
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Aspiring Pharmacist | Passionate about Advancing Healthcare | Committed to Lifelong Learning (graduating ๐2024) Intern at Reign Pharma Former intern at SIUT Hospital and PCSIR Laboratory
I recently attended an enlightening seminar on medical affairs that significantly broadened my understanding of this critical field. The event was a rich source of knowledge, covering a wide array of topics from the latest advancements in medical research to current trends in regulatory affairs. I had the opportunity to learn from industry leaders and experts who shared valuable insights into innovative therapeutic approaches and best practices for improving patient outcomes. This experience has undoubtedly enhanced my perspective on medical affairs and its pivotal role in shaping the future of healthcare. #medicalaffairs #seminar #pharmacy #kupsc
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The healthcare software market has seen ground-breaking regulatory updates in recent months through the FDAโs publication of draft guidance for its proposed 'Prescription Drug Use Related Software' (PDURS) framework.ย ย The PDURS framework underscores the FDA's recognition of the intrinsic value of drug software product integration and lays the groundwork for streamlined regulatory approval processes for these innovations. With growing regulatory support and an expanding pool of promising data, the new generation of software-driven TechBio companies is poised to reshape the industry landscape. ย Our CEO, Hakim Yadi Ph.D. OBE, has collated his thoughts on this forward-thinking framework and its impact on the healthcare market at bit.ly/47SnoGt. Here, jim baker, Closed Loop Medicineโs Senior Director of Quality and Regulatory Affairs, also shares insights to Closed Loop Medicineโs own US regulatory strategy and proactive engagements with the FDA, to strategically position ourselves to take advantage of these updated guidelines once finalized. ย The convergence of regulatory support and industry innovation is paving the way for a new era inย precision medicine, and Closed Loop Medicine is at the forefront of this transformative journey. ย Hakim will be in San Francisco for #JPM2024, 7-10thย January โ please get in touch if youโd like to meet and hear more on Closed Loop Medicineโs approach to enabling personalized dose optimization. #Healthcare #DigitalHealthcare #MedicalDevice #FDA
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Cofounder Peerr | Connecting the Health and Life Sciences world | NHS Clinical Entrepreneur | Podcaster: The Scrubbed in Show
โจ Peerr readers, you're going to like this one! I've always talked about the notion of doctors needing to be in different roomsย so we have representation. Some of us will become excellent clinicians, others may move into VC to enable health innovations and others may move into Pharma to help advance therapies (... there's more than these 3 rooms btw). Now most doctors would be alien to the concept of working and building a career in an environment that's not clinical. So it really does please me when I see creators on Peerr unveiling the 'other' rooms we can be in. Dr. Mayur R Joshiย (Global Medical Head -ย Novartis) shares the unique challenges that come with doctors seeking a transition into the pharmaceutical industry in Medical Affairs roles and how to put plans in place to help overcome them to maximise your chances of making a successful transition. Register on Peerr if you haven't (its free!) and peerr up with him because I'm sure he has more to come...
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๐ฆ Theย ๐๐ฒ๐น๐น & ๐๐ฒ๐ป๐ฒ ๐ง๐ต๐ฒ๐ฟ๐ฎ๐ฝ๐ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐ฆ๐๐บ๐บ๐ถ๐ is your gateway to mastering the complexities of the field, fromย ๐๐ก๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป๐ toย ๐๐๐ ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น๐, and beyond! ๐ฆ ย ๐๐ ๐ฝ๐น๐ผ๐ฟ๐ฒ ๐๐ต๐ฒ ๐ก๐ฒ๐๐น๐-๐ฅ๐ฒ๐น๐ฒ๐ฎ๐๐ฒ๐ฑ ๐๐ด๐ฒ๐ป๐ฑ๐ฎ ๐๐ฒ๐ฟ๐ฒย -ย https://ter.li/ggrnnp ย ๐๐ผ๐ป'๐ ๐ ๐ถ๐๐ ๐๐ต๐ถ๐ ๐ข๐ฝ๐ฝ๐ผ๐ฟ๐๐๐ป๐ถ๐๐ ๐๐ผ: ๐กLearn from industry giants likeย ๐๐ฟ๐ถ๐๐๐ผ๐น ๐ ๐๐ฒ๐ฟ๐ ๐ฆ๐พ๐๐ถ๐ฏ๐ฏ,ย ๐ฏ๐น๐๐ฒ๐ฏ๐ถ๐ฟ๐ฑ ๐ฏ๐ถ๐ผ, andย ๐ข๐ฟ๐ฐ๐ต๐ฎ๐ฟ๐ฑ ๐ง๐ต๐ฒ๐ฟ๐ฎ๐ฝ๐ฒ๐๐๐ถ๐ฐ๐ onย ๐ผ๐๐ฒ๐ฟ๐ฐ๐ผ๐บ๐ถ๐ป๐ด ๐น๐ฎ๐๐ป๐ฐ๐ต ๐ฐ๐ต๐ฎ๐น๐น๐ฒ๐ป๐ด๐ฒ๐. ๐กDiscover theย ๐ฝ๐ผ๐๐ฒ๐ฟ ๐ผ๐ณ ๐ฒ๐ฎ๐ฟ๐น๐ ๐บ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ฎ๐ณ๐ณ๐ฎ๐ถ๐ฟ๐ ๐ถ๐ป๐๐ผ๐น๐๐ฒ๐บ๐ฒ๐ป๐ in product development with insights fromย ๐๐ฑ๐ถ๐๐ฎ๐ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ถ๐ป๐ฒ,ย ๐๐บ๐บ๐ฃ๐๐๐ง ๐๐ถ๐ผ, andย ๐ฉ๐ผ๐ฟ ๐๐ถ๐ผ. ๐กEmbed a ๐ฝ๐ฎ๐๐ถ๐ฒ๐ป๐-๐ณ๐ถ๐ฟ๐๐ ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐ฎ๐ฐ๐ต throughout the drug development lifecycle, guided by leaders likeย ๐๐ฑ๐ฎ๐ฝ๐๐ถ๐บ๐บ๐๐ป๐ฒ andย ๐๐น๐ฒ๐ ๐ถ๐ผ๐ป ๐๐ถ๐ผ๐ฝ๐ต๐ฎ๐ฟ๐บ๐ฎ๐ฐ๐ฒ๐๐๐ถ๐ฐ๐ฎ๐น๐. ย ๐๐ถ๐ป๐ฑ ๐ข๐๐ ๐ ๐ผ๐ฟ๐ฒ ๐๐ฒ๐ฟ๐ฒย -ย https://ter.li/ggrnnp ย We hope you'll join fellowย ๐๐ต๐ถ๐ฒ๐ณ ๐ ๐ฒ๐ฑ๐ถ๐ฐ๐ฎ๐น ๐ข๐ณ๐ณ๐ถ๐ฐ๐ฒ๐ฟ๐ย andย ๐๐ฒ๐ป๐ถ๐ผ๐ฟ ๐น๐ฒ๐ฎ๐ฑ๐ฒ๐ฟ๐ย inย medical affairs,ย medical communications,ย field medical,ย andย medical science liaisons this December for unparalleled networking and learning! ย #CellAndGeneTherapyMedicalAffairsSummit
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Navigating the complex regulatory landscape of clinical trials can be overwhelming for companies new to clinical research. TASK offers unparalleled support to biotech businesses, assisting with planning and submissions. Our regulatory expertise ensures a smooth journey through the intricate pathways of clinical trial compliance. #RegulatoryAssistance #TASKSupport #ClinicalCompliance
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Marketing Principal at RQM
2moIn addition to the RQM LinkedIn page, videos will also be published to our Device Advice podcast and YouTube channel. Subscribe and listen at the links below! ๐ง๐บ ๐ Apple Podcasts: https://podcasts.apple.com/us/podcast/device-advice-by-rqm/id1515256208?uo=4 ๐ถ Spotify: https://open.spotify.com/show/1oqjEQzc1KFP09ofvrcWlE โถ๏ธ YouTube: https://youtu.be/vCi1JR13qlc?si=stkkv_FVcsNmLtJr