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Clinical trials - Regulation EU No 536/2014 and EMA Policy/0070
 
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Presentation from Scott Pharma Solutions Ltd on EU Regulation No 536/2014 and EMA Policy/0070. Global Publication Planning 2017: The Challenges of Publishing in an Era of Increased Disclosure, held in Basel Switzerland on 6th November 2017. Publications professionals attended this free one-day seminar, designed specifically for the pharmaceutical industry. The event was a unique opportunity to hear from industry peers about the latest disclosure requirements and policies, the responses to these changes and the implications and impact upon working practices, including data sharing and layperson summaries. In addition to formal presentations, we held smaller breakout sessions around engaging with authors and raising the profile of publications within the organisation. Ensure you register for future free events at http://howtopublishresearch.com/events/
Module 05 - Clinical trials in the EU
 
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Moderator: Fergus Sweeney, EMA - Clinical trials authorisation in the EU: present and future - Transparency on clinical trials information in the EU
Views: 1551 emainfo
Regulatory Documents For Clinical Research Sites Webinar
 
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Regulatory Documents For Clinical Research Sites Webinar http://www.TheClinicalTrialsGuru.com Site Owner Academy: http://www.theclinicaltrialsguru.com/site-owner-academy/ My CRO: http://www.DSCScro.com My CRA Academy: http://www.TheCRAacademy.com My Research News Site: http://www.TheClinicalScoop.com Call/Text: (949) 415-6256 Follow Me On: SnapChat: username is dansfera Instagram: https://instagram.com/dansfera Twitter: https://twitter.com/TheRealDanSfera Facebook: https://www.facebook.com/dansfera LinkedIn: https://www.linkedin.com/profile/view... My iTunes Podcast: https://itunes.apple.com/us/podcast/random-musings-from-the-clinical-trials-guru/id1245751329 My Stitcher Podcast: http://www.stitcher.com/podcast/dan-s... Google Play Podcast: https://playmusic.app.goo.gl/?ibi=com.google.PlayMusic&isi=691797987&ius=googleplaymusic&link=https://play.google.com/music/m/Ikoltbj2pxcbscwwajoixxdhix4?t%3DRandom_Musings_From_The_Clinical_Trials_Guru%26pcampaignid%3DMKT-na-all-co-pr-mu-pod-16
Views: 1078 Dan Sfera
Navigating the Expanding Regulations of ClinicalTrials.gov Registration and Results Reporting
 
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Webinar: Navigating the Expanding Regulations of ClinicalTrials.gov Regulations and Results Reporting Access the webinar slides here: http://bit.ly/2IhQXcI Originally presented April 24, 2018 Anthony Keyes, Program Manager at the Johns Hopkins University School of Medicine ClinicalTrials.gov Program, reviews the federal regulations regarding registration and results reporting of clinical trials.
Views: 233 Advarra
Understanding Clinical Trials
 
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National Conference 2018 - Presented by Ms Cindy Manchulenko For more information about multiple myeloma, visit myeloma.ca.
Views: 56 Myeloma Canada
Survival of a Whistleblower – Peter C. Gøtzsche at Summer Institute 2018
 
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SURVIVAL OF A WHISTLEBLOWER To be a whistleblower is not easy. Particularly not in healthcare, which is riddled with financial conflicts of interest, corruption, political ambitions about becoming re-elected by promising people screenings that do more harm than good, and personal hobby horses. Part of big pharma’s business model is organized crime, which envolves fraud, both in research and marketing. Our prescription drugs are the third leading cause of death, after heart disease and cancer, and I have estimated, based on the best research I could find, that psychiatric drugs alone are also the third leading cause of death. Yet, hardly anyone raises an eyebrow; in fact, we irrigate whole populations with psychiatric drugs as if they were mental fertilizers. Most whistleblowers suffer a terrible fate. Peter Rost has described how things went for 233 people who blew the whistle on fraud: 90% were fired or demoted, 27% faced lawsuits, 26% had to seek psychiatric or physical care, 25% suffered alcohol abuse, 17% lost their homes, 15% got divorced, 10% attempted suicide and 8% went bankrupt. But in spite of all this, only 16% said that they wouldn’t blow the whistle again. I shall try to explain how it was possible for me to blow the whistle for 30 years and yet still have a highly rewarding career. PETER C. GØTZSCHE Professor Peter C. Gøtzsche graduated as a Master of Science in Biology and Chemistry in 1974 and as a Physician 1984. He is a specialist in internal medicine; worked with clinical trials and regulatory affairs in the drug industry 1975-1983, and at hospitals in Copenhagen 1984-95. SUMMER INSTITUTE The 2018 Summer Institute on Bounded Rationality took place on June 19 – 27, 2018, at the Max Planck Institute for Human Development in Berlin, Germany.
New Drugs and Clinical trials rules, 2019: chapter VI compensation
 
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New Drugs and Clinical trials rules, 2018 : chapter VI compensation
Are clinical trials in China in need of more regulation?
 
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Clinical trials on human subjects in China have sparked a debate on health risks for its participants. Though rules and regulations are enacted for protection safeguards, huge issues have arisen over their enforcement and a designated authority of sufficient clout to preside over them.
Views: 287 CGTN
Understanding Clinical Trials
 
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Listen to this session recorded at our 2018 North American Educational Forum on Lymphoma, where Lauren Pinter-Brown, MD, FACP (UC Irvine Health), discusses clinical trials for lymphoma. The Lymphoma Research Foundation is the nation's largest non-profit organization devoted to funding innovative research and providing people with lymphoma and healthcare professionals with up-to-date information about this type of cancer. LEARN MORE! http://lymphoma.org/ http://facebook.com/lymphomacommunity http://twitter.com/lymphoma http://instagram.com/lymphomacommunity/
Clinical trials' International guidelines, laws and regulations - IITA video 3
 
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Clinical trials International guidelines, laws and regulations
Views: 70 Tokunbo Onabanjo
Clinical Trials: Conducting the Study
 
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The module is designed to provide a practical context to help clinical research professionals learn about conducting clinical trials. Using an interactive case study with realistic scenarios designed to illustrate the learning points, the program follows the activities of a fictitious clinical investigator and her staff as they conduct a clinical trial. As learners make decisions during the clinical trial, the program explains how each scenario relates to the regulations, guidelines, and practices for conducting clinical trials. The module takes an average of 3 hours to complete. This eLearning module can be purchased individually or as part of the Clinical Trial Fundamentals eLearning Program or Clinical Trial Management Comprehensive eLearning Bundle. Learn more - https://www.diaglobal.org/en/course-listing/elearning/2016/03/clinical-trials-conducting-the-study
Views: 29 DIA
GDPR In Clinical Trials
 
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If someone asked you to explain in 2 minutes or less EXACTLY  what GDPR is and why it is so important to many organizations, particularly those participating in clinical trials, would you be up for the challenge?  In this week's episode, we discuss exactly what GDPR is (now you can show off to colleagues at your company's water cooler) and key points to keep in mind in order to avoid very steep fines (Up to 20 Million EUR or more) to your organization. Get a copy of the book 'The Four Villains of Clinical Trial Agreement Delays and How To Defeat Them' on Amazon: https://amzn.to/2uzq9fd To be notified first of all new ClinBiz videos and news, subscribe to our newsletter at (www.clinbiz.com). Have you registered for the ClinBiz Summit yet? Don't miss this conference focused on clinical contracting, clinical outsourcing and clinical financial management. For more information and to register go to (www.clinbizsummit.com). Twitter: https://twitter.com/ClinBiz Facebook: https://www.facebook.com/clinbiz/ LinkedIn: https://www.linkedin.com/company/clinbiz/ https://www.instagram.com/clinbiz/ * Disclaimer: All ClinBiz videos are for informational and entertainment purposes only and not to be used as legal or professional advice. ClinBiz will not be liable for any use or misuse of the information provided through any of its videos, podcasts, blog posts, presentations or any other materials. #ClinBiz #ClinicalTrials #GDPR
Views: 381 ClinBiz
Chapter 4: PRINCIPLES OF GOOD CLINICAL PRACTICE (ICH-GCP)
 
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Chapter 4 : PRINCIPLES OF GOOD CLINICAL PRACTICE is a part of the YouTube series "Clinical Researcher" by Dr. Sulaiman Sait. Clinical Researcher is your destination to learn everything about Clinical Research. This video lecture features an insight into the Clinical Trial Industry by focusing on the guidance for good clinical practice. ICH-GCP is an universal standard for ethical conduct of clinical trials globally. Find more details about ICH-GCP by clicking https://goo.gl/tTMHnL Note: This video contains royalty free images. You can ask any questions pertaining to Clinical Research by filling in this form: https://goo.gl/kAZjZJ Clinical Researcher Facebook Page: https://www.facebook.com/ClinicalResearcher
Views: 2283 CLINICAL RESEARCHER
Clinical Trials in Central Europe
 
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What are the special characteristics of Clinical Trials in Central Europe? Interview with Dr. Andreas Grund and Dr. Jiří Paseka.
Views: 178 GCP-Mindset
Future of Clinical Data and Medical Device Regulation 2017/745
 
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For questions about this topic, please contact [email protected] This presentation provides an overview of the new requirements of Medical Device Regulation 2017/745 as well as of the MEDDEV 2.7/1 Rev. 4 regarding clinical evaluations. Sandra Bugler, M.Sc. provides insights into the conduction of a clinical evaluation. Learn about the: Interpretation of new requirements Structure of clinical evaluation reports Challenges regarding equivalent devices Clinical data for class III and implantable devices Post-Market Clinical Follow-up
Views: 1391 NSF International
Changes in the regulation on pharmacovigilance, Conference "Clinical Trials in Russia-2017”
 
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Presentation on changes in the regulation on pharmacovigilance at the 6th international conference “Clinical Trials in Russia”, 14-15 November 2017
Covance Webinar: Take the Risk Out of Clinical Trials
 
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With a variety of disparate and unconnected systems, clinical trials often lack uniformity. This leads to compliance issues, process inefficiencies and minimizes the ability to clearly track study progress. To address this critical issue, Covance developed a new addition to the robust Xcellerate® Informatics Suite: Xcellerate Risk and Issue Management. In this webinar, our experts will present the benefits of using this single, agnostic system to create, view and manage issues. You’ll see how CRAs, central monitors and project managers are enabled to take on risk, escalate issues and cascade automated actions across sites.
Views: 437 Covance
Kraft Precision Medicine Accelerator 2018 Roundtable: Clinical Trials Panel on Platform Trial Design
 
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Clifton Leaf, Editor-in Chief of Fortune Magazine leads a discussion with Brian Alexander, Dana Farber, Amy McKee, FDA, and Laura Pearce, Cancer Research Institute on improving innovative clinical trial design and identifying effective therapies quickly.
General Data Protection Regulation: Likely lawful basis for research
 
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The General Data Protection Regulation (GDPR) and forthcoming Data Protection Act will come into force on 25 May 2018 in the UK. This animation is based on guidance produced by the MRC Regulatory Support Centre, which was written in consultation with the UK Information Commissioner's Office. More GDPR resources can be found here: https://mrc.ukri.org/research/facilities-and-resources-for-researchers/regulatory-support-centre/gdpr-resources/ And more information on the Regulatory Support Centre can be found here: https://mrc.ukri.org/research/facilities-and-resources-for-researchers/regulatory-support-centre/ The Medical Research Council is part of UK Research and Innovation https://mrc.ukri.org/
Principles of ICH GCP
 
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Good clinical practice also known as ICH GCP or simply GCP is an international quality standard that is provided by the International Conference on harmonization or ICH which governments can transpose into regulations for clinical trials involving human subjects. Good clinical practice guidelines include protection of human rights as a subject in clinical trials, it also provides assurance of the safety and efficacy of the newly developed compound. Good clinical practice guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of all stakeholders such as the clinical trial sponsors, clinical research investigators and monitors. In this lecture we will review what is good clinical practice, the definition of GCP, and what its purpose and objectives. We will focus on the 13 principles of GCP
Views: 8141 Chee-Onn Leong
EUPATI webinar GDPR + clinical trials
 
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This webinar took place on 29 October 2018. You can find a video recording and the presentations used on the EUPATi website as well. Amongst other profound changes and consequences, the EU’s new General Data Protection Regulation also influences how clinical trials can recruit and be organised. Two legal experts discuss these consequences and what they from the perspective of medicine research and development.
Netflix's The Bleeding Edge Review (Medical Device Clinical Trials)
 
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Netflix's The Bleeding Edge Review (Medical Device Clinical Trials) In this episode we do a review on the Bleeding Edge, the new netflix documentary on the medical device clinical trial industry. This opened my eyes as i have not worked with medical devices only pharmaceuticals. I had no idea the differences in regulatory process or any of the other differences outlined in the documentary. I strongly recommend anyone in the clinical trial field to check out the documentary. Don't forget to Subscribe for new content! Subscribe: https://youtube.com/eliteclinicalresearch Call or Text: 910-502-3732 Email: [email protected] Podcast: https://anchor.fm/clinical-research-podcast Steemit: https://steemit.com/@ecrgmedia Advertise: [email protected] Watch: » Industry News: https://goo.gl/fNXpQ5 » All Videos: https://goo.gl/87XEFW » Interview Recaps: https://goo.gl/wJsk6W » Glassdoor Reviews: https://goo.gl/AbQzqe We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education In this episode we do a review on the Bleeding Edge, the new netflix documentary on the medical device clinical trial industry. This opened my eyes as i have not worked with medical devices only pharmaceuticals. I had no idea the differences in regulatory process or any of the other differences outlined in the documentary. I strongly recommend anyone in the clinical trial field to check out the documentary. ------------------------------------------------------------------------------------------------------------ Elite Clinical Research Group or ECRG for short is a content creating conglomerate that offers many services to individuals in the clinical research and pharmaceutical space. We always keep our "Why" of improving patients lives in mind with everything we do and are always looking to partner with people that are of like mind. Clinical Research is one of the hottest fields in the world right now and thousands of college graduates, masters candidates and phd graduates are looking to enter the clinical research world. Reach out by comment or email if we can help in any way. -~-~~-~~~-~~-~- Please watch: "CRA Tells The Truth About CRA Career Progression" https://www.youtube.com/watch?v=WiuEKKiftgs -~-~~-~~~-~~-~-
ELIXIR Webinar: EU General Data Protection Regulation and Research Data Sharing
 
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The ELIXIR Webinar presented the EU General Data Protection Regulation and its implication for sharing of research data. & February 2018, Slides available: https://www.elixir-europe.org/events/webinar-gdpr
Views: 930 ELIXIR - Europe
Evolution of Clinical Trial Regulations in India by Dr Ragunadha Rao
 
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Master class in Medical Oncology for Post Graduates 2018 organised by Integrated Cancer Care Group (ICCG) & Cancer Institute (WIA)-Adayar & JIPMER. Visit: http://iccgindia.com/
PSA Group#13: Regulations on Clinical Trials
 
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Analyzing different aspects of FDA Regulations of Clinical Trials: -Functions -When The FDA Was Created/Why They Were Needed -Regulations of 21 CFR 54 resulting in Good Clinical Practices -Leading to Protection of Patients via Informed Consent Document
Views: 130 Obsessionals
Strategy for real-time clinical trials using Blockchain
 
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As part of my project on Blockchain Strategy at RMIT University, I have put together a 5 minute presentation on a use case for real-time clinical trials.
Views: 92 Eoin Hanley
Сlinical trial opportunities under EAEU regulation, Conference "Clinical Trials in Russia-2017”
 
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Presentation on international clinical trial opportunities under EAEU regulation by Alexander Solodovnikov from Worldwide Clinical Trials at the 6th international conference “Clinical Trials in Russia”, 14-15 November 2017
Half of European clinical trials have not complied with EU rules on reporting results
 
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Half of clinical trials on the EU register have not reported results, despite rules requiring results to be posted within 12 months of completion. Although compliance with EU rules has been poor overall, trials with commercial sponsors are substantially more likely to have posted results than trials with non-commercial sponsors, such as universities, hospitals, governments and charities. EU registry data commonly contain inconsistencies that might prevent even regulators assessing compliance. The results of clinical trials are used by clinicians, patients, and policy makers to make informed choices about which treatments work best. The European Commission therefore requires all trials conducted in Europe on medicinal products to report results directly on to the EU Clinical Trials Register (EUCTR) within 12 months of trial completion; but compliance has never been assessed. So a team of researchers, led by Dr Ben Goldacre at the University of Oxford, set out to assess compliance with these rules, explore factors associated with non-compliance, rank sponsors by compliance, and create a website for live ongoing audit of compliance. Of 7,274 trials where results were due, they found that 49.5% reported results. Trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68% v 11%), as were trials by a sponsor who conducted a large number of trials (78% v 18%). More recent trials were also more likely to report results. Unexpectedly, the researchers also found extensive evidence of errors, omissions, and contradictory data in EUCTR - notably, that 29.4% of trials marked as “completed” gave no completion date, which prevents ascertainment of compliance with reporting requirements. The paper also describes the development of the EU TrialsTracker website, available online at EU.trialstracker.net. This website gives detailed information on the trial reporting performance of every individual drug company, university and hospital conducting clinical trials in Europe. It shows which sponsors are the best or worst at complying with the law, and gives detailed information on the individual trials that have failed to report results onto the trials register. The information on EU.trialstracker.net updates every month, so sponsors who report more trials will find their improved performance reflected on the website.
Views: 342 The BMJ
What is GOOD CLINICAL PRACTICE? What does GOOD CLINICAL PRACTICE mean?
 
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What is GOOD CLINICAL PRACTICE? What does GOOD CLINICAL PRACTICE mean? GOOD CLINICAL PRACTICE meaning - GOOD CLINICAL PRACTICE definition - GOOD CLINICAL PRACTICE explanation. Source: Wikipedia.org article, adapted under https://creativecommons.org/licenses/by-sa/3.0/ license. SUBSCRIBE to our Google Earth flights channel - https://www.youtube.com/channel/UC6UuCPh7GrXznZi0Hz2YQnQ Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects. A similar guideline for clinical trials of medical devices is the international standard ISO 14155, which is valid in the European Union as a harmonized standard. These standards for clinical trials are sometimes referred to as ICH-GCP or ISO-GCP to differentiate between the two and the lowest grade of recommendation in clinical guidelines. GCP follows the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) of GCP guidelines. GCP enforces tight guidelines on ethical aspects of a clinical study. High standards are required in terms of comprehensive documentation for the clinical protocol, record keeping, training, and facilities, including computers and software. Quality assurance and inspections ensure that these standards are achieved. GCP aims to ensure that the studies are scientifically authentic and that the clinical properties of the investigational product are properly documented. GCP guidelines include protection of human rights for the subjects and volunteers in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP guidelines include standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry monitors are often called clinical research associates. A series of unsuccessful and ineffective clinical trials in the past were the main reason for the creation of ICH (The International Council for Harmonisation) and GCP guidelines in the US and Europe. Such was the case with the Elixir Sulphanilamide disaster in 1937 or the Thalidomide incident of the 1960’s. These discussions ultimately led to the development of certain regulations and guidelines, which evolved into the code of practice by which all those involved in clinical research now work. This code is known as International Conference on Harmonisation of Good Clinical Practice The first indicator in the regulation of drugs is the Food and Drugs Act established in the US in 1906. It is considered to be the result of very dangerous and even deadly drugs that could have been sold legally just like any other medical goods. For example, such drugs were ‘Grandma’s Secret’ and ‘Kopp’s Baby’s Friend’, which contained a huge amount of morphine. ‘Dr King’s Consumption Cure’ and ‘Dr Bull’s Cough Syrup‘ are examples of drugs which had large doses of morphine and chloroform as well. Nowadays, good clinical practices can be applied to different aspects of any given company, including: GCP for Cosmetics, Investigators, Monitors, Medical Devices, Veterinary GCP and others.
Views: 3693 The Audiopedia
Balanced Regulations on Clinical Trials.wmv
 
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The FDA's restrictions on clinical trials can be perceived as necessary or superfluous. The FDA, or Food and Drug Administration, places restrictions on clinical trials, which are drug tests on humans, for the patients' safety. Without the FDA, the trial participants would not be consistently protected from potentially harmful drugs. However, if the restrictions become too strict they will cause delayed and more expensive drug production. Some patients, including a recent trial participant believe some of the regulations create more hassle than needed. None the less, some restrictions on trials obstruct medical progress, most simply protect the patients.
Views: 122 skc2015
The Regulatory Authorities’ Voice 2018 - Switzerland
 
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Dr. Lada Leyens, Clinical Study Reviewer, Division Clinical Trials, Swiss Agency for Therapeutic Products (Swissmedic), Bern (CH) 24. The Regulatory Authorities’ Voice 2018 CLINAM 2018 11th European and Global Summit for Clinical Nanomedicine, Targeted Delivery and Precision Medicine Hall Montreal 4.9.18
Views: 7 TAUVOD
DIA 2018: Disparities between FDA and EMA Regulatory Review Processes
 
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Chris Slawecki, Sr. Digital Copy Editor, DIA, speaks with Student Poster Award Winner Bijan Motamedi at the DIA 2018 Global Annual Meeting in Boston, MA.
Views: 178 DIA
The IMPACT Partnership: Improving regulation and turnaround of transplant clinical trials
 
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There is a desperate need for rapid turnaround of transplant clinical trials to bring forward breakthrough therapies. IMPACT is a new partnership that aims to improve regulation and transplant outcomes. Speaking here, Charles Craddock, CBE, FRCP (UK), FRCPath, DPhil, from University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, introduces key trials that will be starting soon, including the PRO-DLI trial (NCT02856464), a trial investigating CPX-351 for untreated acute myeloid leukemia (NCT03335267). This video was recorded at the 2018 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in Lisbon, Portugal.
ESOC - The Foremost Platform for Presenting New Clinical Trials
 
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Bart van der Worp, Kennedy Lees and Stephanie Debette discuss which major trials were presented at ESOC 2018 and why it's so important to be there to hear them first hand Register today https://eso-conference.org/
TRACO 2018 - Clinical trials and TGF beta
 
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TRACO 2018 - Clinical trials and TGF beta Air date: Thursday, September 27, 2018, 4:00:00 PM Category: TRACO Runtime: 01:50:07 Description: Clinical trails and TGF beta For more information go to http://ccr.cancer.gov/training/trainee-resources/courses-workshops/traco Author: Jill P. Smith, MD, Georgetown University and Sonia B. Jakowlew., PhD, NCI, NIH Permanent link: https://videocast.nih.gov/launch.asp?26074
Views: 302 nihvcast
In silico trials
 
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In silico trials: how modeling and simulation and a changing regulation combined can accelerate the development and approval of new drugs and medical devices. Invited Research Seminar. Luca Emili. Fundador y CEO de In Silico Trials Technologies. October, 26th 2018. Room 55.410 Campus del Poblenou.
Different Regulatory authorities of different countries_for pharmacovigilance
 
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Hi Friends, This video enlists regulatory authorities of different countries. This is commonly asked question while facing pharmacovigilance and clinical trial interviews. If you like this video, please subscribe, share and hit the bell icon for more such videos: You may also like presentation on: Clinical trials: Basics and Phases of clinical trials: https://youtu.be/p9BnjX5aFbQ Pharmacovigilance: Overview and important information of ICH: https://youtu.be/asDHhGdjN0o What is life science industry and how it differs from health care industry? https://youtu.be/JFrK70XZkts ICSR processing steps in pharmacovigilance: https://youtu.be/nJeeKou5f5Y Overview of pharmacovigilance: https://youtu.be/N2EKE1oZjn8 Development safety update report (DSUR) in pharmacovigilance: https://youtu.be/lwP5MZlKfoU Thalidomide disaster_important topic for pharmacovigilance: https://youtu.be/coJPUC7f3wM Visit my blog at: http://themedicosindia.blogspot.com/
Views: 441 Paresh Solanki
[Webinar] PolarisDMD: Phase 3 Clinical Trial of Edasalonexent, a Novel NF-kB Inhibitor - Nov 2018
 
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PPMD and Catabasis hosted a webinar on November 7, 2018 to discuss the Phase 3 PolarisDMD clinical trial studying edasalonexent in Duchenne muscular dystrophy, which is enrolling boys ages 4 to 7 (up to 8th birthday) regardless of mutation type who have not been on steroids for at least 6 months.
What is a clinical trial?
 
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https://www.cancercenter.com A clinical trial is a research program to evaluate a new medical treatment, drug or device. These research studies offer a systematic approach to finding new and improved methods of treating, preventing, screening for and diagnosing different diseases. Federal regulations require that patients be informed about all aspects of the clinical trial so that they understand the goals, risks and potential benefits before providing informed consent. At Cancer Treatment Centers of America® (CTCA), the research team decides to participate in a clinical trial only after careful consideration of the relative benefit to patients. Watch the video to learn more about clinical trials at CTCA®, and visit https://www.cancercenter.com/clinical-trials/.
Oncology Clinical Trial Design - Impact of the Latest Industry Guidelines for Pharma
 
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In August 2018, the FDA and ASCO released exciting new guidance around oncology clinical trials. Dr. Andrew Merron, Executive Director, DRG Oncology, reviews: - Key points of the guidance - Why this guidance is significant for patients and oncology drug developers - Key takeaways for pharma
Rett Syndrome Research and Clinical Trials
 
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Daniel Glaze, Medical Director of the Blue Bird Circle Rett Center and a Professor in the Departments of Pediatrics and Neurology at Baylor College of Medicine in Houston, discusses ongoing Rett syndrome research and clinical trials, including the ongoing phase 3 STARS trial. The STARS clinical study (Sarizotan Treatment of Apneas in Rett Syndrome) in patients with Rett syndrome is expected to complete enrollment in H2 2018, and Newron expects to report results from the STARS study in H1 2019. Currently over 100 patients, aged six years and over, have qualified for inclusion into the trial. Based on the current rate of screening and qualification, Newron anticipates that randomization of the target number of 129 patients will be completed in H2 2018. The STARS study is being performed in patients who present with clinically significant apneas during the course of the disease. Apneas are a cardinal feature of Rett syndrome, present in approximately 70% of patients, and contribute significantly to other co-morbidities, as well as leading to a reduced quality of life. Sarizotan is a highly selective compound modulating the activity of specific serotonin or dopamine receptors in the brain. It is currently in a the potentially pivotal STARS study for Rett syndrome and has the potential to become the first drug approved for this orphan disease, and the first therapy to become independently commercialized by Newron. Rett syndrome is a severe neurodevelopmental disorder primarily affecting females, with an estimated prevalence ranging from 1 in 10,000 to 1 in 20,000 females. There are no approved treatments available. Rett syndrome is characterized by a loss of acquired fine and gross motor skills and the development of neurological, cognitive and autonomic dysfunction, which leads to loss of ability to conduct daily life activities, walk or communicate. Rett syndrome also is associated with a reduced life expectancy.
Views: 85 CheckRare
Being proactive with clinical trials
 
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How a clinical trial and cutting-edge research helped Richard survive stage IV kidney cancer. For more information, visit: www.utsouthwestern.edu/kidneycancer.
Views: 1998 UTSWMed
Clinical trials in the pediatric population, Conference "Clinical Trials in Russia-2017”
 
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Presentation on clinical trials in the paediatric population at the 6th international conference “Clinical Trials in Russia”, 14-15 November 2017
Serious Adverse Event Reporting in Clinical Trials
 
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Serious Adverse Event Reporting in Clinical Trials with Upto Date Requirements of Compensation & Reporting Timeframe in India
Views: 968 Catalyst Clinical
Clinical Trials: One of the most important medical inventions in the last 100 years
 
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Professor Sallie Lamb, Co-Director of the Oxford Clinical Trials Research Unit at the University of Oxford, talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias. Professor Lamb describes how trials have progressed the management of nearly all medical conditions, and what challenges remain. She discusses the range of ethical dilemmas raised by clinical trials, and the difficulties of operationalising large experiments involving many hundreds and sometimes thousands of people.
Views: 878 Oxford BRC
Running Clinical Trials in Japan
 
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Running Clinical Trials in Japan In this global clinical trials environment at some point during your career you could end up running a clinical trial in the great country of Japan. In Japan there are different customs when it comes to interacting with one another and naturally that spills over into the way clinical trials are conducted. In this episode I discuss what I learned about running a clinical trial in japan during one of my studies. Don't forget to Subscribe for new content! Subscribe: https://youtube.com/eliteclinicalresearch Email: [email protected] Podcast: https://anchor.fm/clinical-research-podcast Steemit: https://steemit.com/@ecrgmedia Advertise: [email protected] Watch: » Industry News: https://goo.gl/fNXpQ5 » All Videos: https://goo.gl/87XEFW » Interview Recaps: https://goo.gl/wJsk6W » Glassdoor Reviews: https://goo.gl/AbQzqe We do: » Insider Interviews » Resume Reviews » Question and Answer » Discuss all things Clinical Research » News and Product Reviews » Education In this global clinical trials environment at some point during your career you could end up running a clinical trial in the great country of Japan. In Japan there are different customs when it comes to interacting with one another and naturally that spills over into the way clinical trials are conducted. In this episode I discuss what I learned about running a clinical trial in japan during one of my studies. ------------------------------------------------------------------------------------------------------------ Elite Clinical Research Group or ECRG for short is a content creating conglomerate that offers many services to individuals in the clinical research and pharmaceutical space. We always keep our "Why" of improving patients lives in mind with everything we do and are always looking to partner with people that are of like mind. Clinical Research is one of the hottest fields in the world right now and thousands of college graduates, masters candidates and phd graduates are looking to enter the clinical research world. Reach out by comment or email if we can help in any way. -~-~~-~~~-~~-~- Please watch: "CRA Tells The Truth About CRA Career Progression" https://www.youtube.com/watch?v=WiuEKKiftgs -~-~~-~~~-~~-~-
DIA 2018: Biologics Clinical Trials in Korea
 
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Youngshin Lee, SVP & Managing Director, South Korea & ASEAN, DIA, discusses biologics clinical trials in Korea with YunKyong Lee, Handok Inc., and Il Sun Hong, Samsung Bioepis.
Views: 77 DIA