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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: 704 emainfo
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/
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: 431 Dan Sfera
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: 286 ClinBiz
Clinical trials' International guidelines, laws and regulations - IITA video 3
 
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Clinical trials International guidelines, laws and regulations
Views: 29 Tokunbo Onabanjo
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: 5355 Chee-Onn Leong
Clinical Trials Data Management System Demo: DataInK v 0.9 by StatPharm
 
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Clinical Trials Data Management System Demo: DataInK v 0.9 by StatPharm DataInK: Data -- Information -- Knowledge
Views: 88 Stat Pharm
Clinical trials Phases 0 - IV
 
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The Phases of clinical trials
Views: 2157 Tokunbo Onabanjo
Adaptive Clinical Trials | Amgen Science
 
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In a bid to make clinical trials faster, less costly, and more successful, Amgen is making adaptive trial designs its default setting for clinical research. Visit AmgenScience.com to learn more.
Views: 673 Amgen
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: 639 CLINICAL RESEARCHER
The Great Debate: What is Enough … Women in Clinical Trials (complete recording)
 
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This is the full recording of "The Great Debate: What is Enough ... Women in Clinical Trials?". The program was recorded on May 16th, 2018, and sponsored by the FDA Office of Women’s Health. It includes an introduction by Office of Women’s Health Director Marsha Henderson, a keynote address by FDA Commissioner Scott Gottlieb, and the complete debate. The Great Debate centered on the challenges and complexity of the question “What is enough?” when determining participation of women in cardiovascular disease clinical trials. The debate participants were two leading cardiovascular experts: Ellis F. Unger, M.D., FDA Center for Drug Evaluation and Research, and Rita Redberg, M.D., M.Sc., F.A.C.C., UCSF. It was a robust discussion centering on a complex question that has been debated among academia, federal, and non-government and consumer organizations for more than a quarter century. 0:00:00 – 0:04:02 Opening Remarks, Marsha Henderson 0:04:03 – 0:14:40 Keynote Address, FDA Commissioner Scott Gottlieb, M.D. 0:15:06 – 0:19:54 Introduction, Marjorie Jenkins, M.D. 0:20:20 – 1:21:40 Debate
Views: 104 USFoodandDrugAdmin
Our team: clinical trials practitioner
 
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One of our clinical trial practitioners, Abigail, discusses the importance of supporting patients on clinical trials and their loved ones, as well as collecting data that could one day help treat future patients. If you would like to know more about our research studies and trials please visit our website http://www.guysandstthomas.nhs.uk/research/studies/studies-and-trials.aspx
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: 14 DIA
Classification Medical Device in EU (Medical Device Regulation MDR 2017/745)
 
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Medical Device Regulation Training - Within less than 10 minutes you'll learn how to classify a Medical Device in Europe with the new Medical Device Regulation MDR 2017/745. I'll tell you How many classes it exists, why this is important. I'll also inform you about all the rules that exist and in the end, you'll have some exercises to test your knowledge. I will also provide you with a free form to download so you can be more efficient when you'll have to classify your product. Look at the notes below for the link *************************** Links ************************** - Participate to the free Mini-Course on MDR 2017/745 (6 days challenge) https://easymedicaldevice.com/mdr - Free Form to classify your medical device https://easymedicaldevice.com/class - Article on Medical Device Classification in Europe https://easymedicaldevice.com/mdclass ------------------------------------------------------------------------------------------- Social Media to follow Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice -------------------------------------------------------------------------------------------- Monir El Azzouzi Easy Medical Device #medicaldevice #medtech #regulation
Views: 534 Easy Medical Device
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: 21 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
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: 2315 The Audiopedia
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: 196 Advarra
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: 692 ELIXIR - Europe
SOCRA Review: Investigator Roles and Responsibilities in Clinical Research
 
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Presented by: John Naim, Ph.D. Director, WVU Clinical Trials Research Unit
Views: 2303 WVCTSI
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: 126 Obsessionals
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
Module 01 - Setting the scene: introduction to the EU regulatory network
 
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Moderator: Agnès Saint-Raymond, EMA - The EU and the EU regulatory network - The EMA role
Views: 987 emainfo
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.
Phase 1 Clinical Trials
 
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Clinnovo Offers Services & Training In Clinical Research Course, Clinical Data Management Training, Sas, SDTM, ADaM, Medical Coding, Imaging, Pharmacovigilance and Drug Regulatory Affairs. Online Clinical Course, Class Room, Pg Diploma, Internships Available. Phase 1 Trials, Human Pharmacology study, Safety, protocol Document, Pharmacokinetics, pharmacodynamics, Maximum Tolerated Dose(MTD), Subjects, Safety Evaluation, Single ascending dose(SAD), Multiple ascending dose(MAD), Inform Consent form, Case Report Form, Investigator Brochure. For More Details Please Contact –http://www.clinnovo.com/ Phone: 040-64635501 OR 9912868928 Email: [email protected] Plot No: 4, Survey No:11/2, Khanamet, Opp To Shilparamam, Hitech City, Hyderabad – 81.
Transparency in Clinical Trials
 
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At the beginning of the Irish Presidency, as Rapporteur on the Clinical Trials Regulation, I ask the Irish Health Minister his opinion on the need for greater transparency in clinical trials.
Views: 108 GlenisWillmottMEP
Ethical Issues in Drug Research - Clinical Trials
 
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Trisha Karani in discussion with Upen Patil, who specializes in Clinical Data Management at Genentech. The growth and advancement of society and technology have added new medical challenges, and different forms of data collection, monitoring and management. The discussion focusses on the ethical practices by Pharma industries during data collection in different stages of drug research, human trials during FDA approval phases.
Views: 1325 Trisha Karani
Pharmacovigilance Europe 2018 London
 
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4th International Conference and Exhibition in Drug Safety, Regulatory Affairs, Risk Management and Clinical Trials | www.pveurope.com | #pveurope | London
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: 797 NSF International
[Webinar] Capricor Therapeutics' HOPE-Duchenne Clinical Trial - November 2017
 
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Capricor Therapeutics joined PPMD for a webinar on November 30, 2017 to discuss the 12-month results from Capricor's HOPE-Duchenne Clinical Trial, as well as the company’s plans for the HOPE-2 Clinical Trial in the first quarter of 2018, pending regulatory approval.
7 News Perth - Clinical Trials in Perth!
 
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Visit https://www.linear.org.au/trials/ to find out how you can get involved!
The FDA Reduces Lifespan Of Average American by 5-10 Years - Mary Ruwart of Death by Regulation
 
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Anarchast Ep.442 Jeff Berwick interviews Author and activist Mary Ruwart, topics include: ever increasing regulations, massive increase in drug discovery and development time and cost, making drugs expensive, FA approval process, many vital drugs not developed. adds up to 5 years off our lives, censored supplements, opioid drugs, political involvement and conflict of interest, Vioxx, Trump and 'right to try', 'free to choose medicine', return of 3rd party testing and certification, Anarchapulco 2019 Mary Ruwart's website: http://www.ruwart.com Anarchapulco February 14-17, 2019, Acapulco, Mexico Anarchapulco 2019 tickets now available at: http://anarchapulco.com Subscribe to Anarchapulco channel to view every speech from Anarchapulco 2018 being released regularly: https://www.youtube.com/c/Anarchapulco?sub_confirmation=1 Anarchast on Facebook: https://www.facebook.com/Anarchast/?ref=ts&fref=ts Anarchast: http://anarchast.com Enjoy our content and would like to see us get more amazing guests and spread the word of freedom? A donation to this BTC address will give us more resources to do so: 16AJs5DFEcfCuXkwmx1o54Ld4yXzPP1gVR
Views: 8601 TheAnarchast
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.
Clinical trials
 
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The...................video deals with IAS current affairs. ................Considering the latest pattern of general studies exam of UPSC, it is important to prepare thoroughly for the current affairs. You need to remember and write important terms in the exam. These videos will build your perspective on divergent issues. From prelims to interview, these videos will increase you understanding and presentation. Subscribe the channel and find more than 1000 videos for IAS preparation. -~-~~-~~~-~~-~- Please watch: "What is Bhima koregaon issue? | Current Affairs-6th Class" https://www.youtube.com/watch?v=HH4smPm8G5s -~-~~-~~~-~~-~-
Views: 338 Brainy IAS
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.
Topic 5: Transparency measures
 
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- Transparency measures regarding paediatric medicine development as planned by European Commission Fabio D’Atri, EC, DG Health and Food Safety - Transparency improvements through Clinical Trials Regulation Fergus Sweeney, EMA - Discussion - Conclusions and next steps
Views: 59 emainfo
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/
KGI PharmD Program: Careers in Pharmacy (Clinical Trials and Regulatory Affairs)
 
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Regulatory affairs (RA) professionals play critical roles throughout the lifecycle of pharmaceuticals, medical devices, biologics, and functional foods. They provide strategic, tactical, and operational direction, and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The regulatory professional's services can be utilized in research and development, clinical trials, extension of premarket approvals, manufacturing, labeling and advertising, and post-market surveillance. Knowledge of clinical research conduct and management involves the design, execution, and management of clinical trials as well as quality assurance and compliance principles are important RA professionals. Writing pre- and post- approval regulatory FDA submission documentation (INDs, NDAs, PMAs etc.) for product clearance or licensure is a common regulatory function. Pharmacists trained in this area can combine their expertise in medications and pharmacy practice with clinical trial management and regulatory affairs knowledge and skills to enhance the development of healthcare products. Learn how KGI is preparing future pharmacists to meet the needs of a rapidly changing landscape in pharmacy practice. Visit kgi.edu/pharmacy for more information.
Views: 10 KeckGrad
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: 65 nihvcast
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's Are Lacking In Critical Areas" https://www.youtube.com/watch?v=HXzpoFAfP1A -~-~~-~~~-~~-~-
The hidden side of clinical trials | Sile Lane | TEDxMadrid
 
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Around half of the clinical trials done on medicines we use today are not published. A tragic truth that needs to be changed, to help doctors do their job properly and to not betray the trust of all those who have volunteered to be part of those trials. Find out more about the AllTrials campaign ad references for claims made in the talk at www.AllTrials.net. In particular, read more about the claim that around half of all clinical trials on the medicines we use today have not published results here http://www.alltrials.net/wp-content/uploads/2016/03/AllTrials-briefing-doc-how-many-clinical-trials-unreported.pdf. Audiovisual producer: Daniel Goldmann. Editing: Xavi Fortino. Film team: Elena Salcedo, Josep Fernández, Daniel Davidson, Nicolás Mazzini, Nacho Valentín, David Ramos, Ignacio Fuentes and Fran Rubio. Síle Lane is director of campaigns and policy at Sense about Science, a charity concerned with the use and abuse of scientific evidence in public life. Síle helps run the global AllTrials campaign for clinical trial transparency which is supported by thousands of people and organisations worldwide. Find out more at www.alltrials.net This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at http://ted.com/tedx
Views: 64754 TEDx Talks
Change is Opportunity! ICH GCP E6 (R2) — 1 Mar 2018
 
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Focus – how regulatory changes will affect investigators and personnel at PHC sites: • An overview of types of clinical research, Canadian regulations and Health Canada • Good Clinical Practice (Revision 2) and Health Canada’s interpretation of the regulations • Help to the PHC clinical research community – PCHRI’s assistance with compliance and clinical research quality improvement • Accessing free resources to enable compliance
Views: 366 CHEOSNews
Clinical Trials Study Initiation
 
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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-study-initiation
Views: 12 DIA
The role of Cure Leukemia in improving access to clinical trials for patients
 
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Cure Leukemia is a leading center for the development of new drug and transplant treatments for patients with hematological cancers. Its aim is to improve the access to the latest clinical trials for patients in the UK with the assistance of research nurses, who play a pivotal role in recruiting patients for transplant clinical trials. In this talk, Charles Craddock, CBE, FRCP (UK), FRCPath, DPhil, from University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, mentions the recognition Cure Leukemia has received and why its role is crucial. Prof. Craddock was speaking from the 2018 European Society for Blood and Marrow Transplantation (EBMT) Annual Meeting in Lisbon, Portugal.
Opening Remarks and Update of Clinical Trial in Alzheimer’s
 
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Dr. Haakon Nygaard presents opening remarks at the UBC Hospital Clinic for Alzheimer Disease and Related Disorders annual Alzheimer Forum in 2017.

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