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Rango Dietrich Glossary - Investigational Medicinal Product Hörbücher
 
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Views: 68 Hörbücher TV
1.4 The life cycle of a medicinal product
 
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1. Overview of the new legislation New Pharmacovigilance legislation training session for patient representatives Speaker: Nathalie Bere, Public Information and Stakeholder Networking, EMA
Views: 2385 emainfo
Rango Dietrich Glossary - Investigational Medicinal Product Hörbücher
 
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Rango Dietrich new single Glossary - Investigational Medicinal Product with a preview sample. Buy this Hörbücher records from Rango Dietrich - Glossary - Investigational Medicinal Product: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Glossary+-+Investigational+Medicinal+Product Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Glossary+-+Investigational+Medicinal+Product/ex/s~details,u~10070311,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Glossary+-+Investigational+Medicinal+Product www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Glossary - Investigational Medicinal Product Label: Pharmaudio Guidelines Date: 2014-03-14 Style: Hörbücher ID: 10244963 ISRC: DEAR41415018 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 11 Feiyr
Rango Dietrich Notes - Non-Investigational Medicinal Product Hörbücher
 
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Views: 28 Feiyr
"From Investigational New Drugs to Clinical Trials" with Stephen W. Frantz
 
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Stephen Frantz delivers a primer on Regulatory Drug Safety Testing and Guidelines.
Views: 5044 UW CoMotion
Rango Dietrich Notes - Non-Investigational Medicinal Product Hörbücher
 
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Views: 13 Hörbücher TV
Rango Dietrich Production - Principles Applicable to Compara Hörbücher
 
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Rango Dietrich new single Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators with a preview sample. Buy this Hörbücher records from Rango Dietrich - Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Production+-+Principles+Applicable+to+Comparator+Product+-+19.+Modifications+of+Comparators Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Production+-+Principles+Applicable+to+Comparator+Product+-+19.+Modifications+of+Comparators/ex/s~details,u~10070311,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Production+-+Principles+Applicable+to+Comparator+Product+-+19.+Modifications+of+Comparators www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Production - Principles Applicable to Comparator Product - 19. Modifications of Comparators Label: Pharmaudio Guidelines Date: 2014-03-14 Style: Hörbücher ID: 10244995 ISRC: DEAR41415048 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 7 Feiyr
Pharmaceutical Supply Chain Integrity and Security: Europe
 
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Pharmaceutical Supply Chain Integrity and Security - Part 1 Regulations in the U.S., Europe and Asia, and international standards Instructor: Arete-Zoe Delivery method: Indirect (Internet) Length: 4 hours of video content CPE credits: n/a The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and safety of pharmaceutical products. In the following modules, we will introduce and describe the regulatory environment in the United States, European Union, in major Asian economies such as Japan, India and China, regulatory policies in Russia, and international standards. The video presentations guide students through highly specialized and often disconnected national and supra-nationals regulatory environments that govern pharmaceutical supply chain. Although national variants of Good Distribution Practice guidelines are the key component, they are not the sole focus of this course. Strategic national interests drive national regulatory policies and direct or limit national and international enforcement efforts. Holistic understanding of regulatory environment in global context is essential for understanding of the challenges in pharmaceutical supply chain in the current globalized, inter-connected and inter-dependent economy. Learn more: http://www.aretezoe.com Systems Approach to Training: http://www.aretezoe.com/#!training-/c1hbi
Views: 436 Arete Zoe
Investigational Drug Accountability: DARF Basics
 
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This video from the NCI Pharmaceutical Management Branch will review the basics of using the NCI Investigational Agent Accountability Record Form, commonly referred to as the Drug Accountability Record Form (DARF). If you are a person with disability and are having difficulty experiencing the content of these videos, please contact the Pharmaceutical Management Branch (PMB), CTEP/DCTD/NCI/NIH, by telephone 240-276-6575 Monday through Friday from 8:30am to 4:30pm Eastern Time or by emailing [email protected] at any time. The Investigational Drug Accountability Training Videos can also be viewed directly on NCI’s website at http://ctep.cancer.gov/branches/pmb/drug_training_videos.htm.
annex 13 Edited
 
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Description
Views: 169 Alaa Matooq
What is New Drug Application?, Explain New Drug Application, Define New Drug Application
 
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#NewDrugApplication #audioversity ~~~ New Drug Application ~~~ Title: What is New Drug Application?, Explain New Drug Application, Define New Drug Application Created on: 2018-11-07 Source Link: https://en.wikipedia.org/wiki/New_Drug_Application ------ Description: The Food and Drug Administration's New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial drug candidates proceed through the entire multi-year process of drug development, concluding with an approved NDA, if successful.The goals of the NDA are to provide enough information to permit FDA reviewers to establish the complete history of the candidate drug. Among facts needed for the application are: Patent and manufacturing information Drug safety and specific effectiveness for its proposed use when used as directed Reports on the design, compliance, and conclusions of completed clinical trials by the Institutional Review Board Drug susceptibility to abuse Proposed labeling and directions for useExceptions to this process include voter driven initiatives for "medical" marijuana in certain states. ------ To see your favorite topic here, fill out this request form: https://docs.google.com/forms/d/e/1FAIpQLScU0dLbeWsc01IC0AaO8sgaSgxMFtvBL31c_pjnwEZUiq99Fw/viewform ------ Source: Wikipedia.org articles, adapted under https://creativecommons.org/licenses/by-sa/3.0/ license. Support: Donations can be made from https://wikimediafoundation.org/wiki/Ways_to_Give to support Wikimedia Foundation and knowledge sharing.
Views: 59 Audioversity
Good Manufacturing Practices Requirements
 
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FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1. Although the guidance appears to remove the need to follow GMPs for Phase 1 products, the need to follow GMPs is still present in the Food, Drug, and Cosmetic Act. Thus the nature and extent of GMP-related activities will depend upon the nature of the investigational drug and the extent of the study that is planned. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected]
Rango Dietrich Release of Batches - 38. Release of Investiga Hörbücher
 
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Views: 6 Hörbücher TV
Rango Dietrich Glossary - Manufacturer or Importer of Invest Hörbücher
 
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Views: 0 Hörbücher TV
Rango Dietrich Production - Labelling - 29. Special Requirem Hörbücher
 
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Views: 5 Feiyr
Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products
 
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Click here for more Information: http://www.audioeducator.com/pharma-biotech/guidance-on-ruo-iuo-products-07-21-2015.htmll Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products Presented By: Dev Raheja, MS, CSP Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 204 AudioEducator
GCP Update Course
 
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It's that time again - all those involved in Clinical Trials involving Investigational Medicinal Products (CTIMPs) need to ensure their Good Clinical Practice (GCP) training is up to date. This trailer, presented by Dr Allan Gaw, describes our half-day update course at the Glasgow Clinical Research Facility in Scotland.
Views: 868 Allan Gaw
Zion Medical - Gammora
 
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Investigational Medicinal Product (IMP) Gammora is a synthetic peptide compound derived from the HIV enzyme integrase, which is responsible for inserting the virus’s genetic material into the DNA of the infected cell. Gammora stimulates the integration of multiple HIV DNA fragments into the host cell’s genomic DNA, to an extent that triggers the self-destruction of the infected cell, called apoptosis. The peptide, produced by San Diego, California -based PolyPeptide Labs, has the potential to cure HIV infected patients, by destroying all cells carrying the HIV virus-genome. As opposed to the commercially available retroviral treatments, the so-called “cocktail,” which merely suppress the spreading of the virus, but do not cure the infection.
Views: 15732 Zion Medical
Rango Dietrich Production - Labelling - 29. Special Requirem Hörbücher
 
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Views: 1 Hörbücher TV
Rango Dietrich Glossary - Manufacturer or Importer of Invest Hörbücher
 
00:53
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Views: 13 Feiyr
What's in an IND? Guide to Writing IND For Biologics
 
01:01:34
This talk was presented by Dr. Zahra Shahrokh, a NINDS consultant at STC Biologics. Dr. Shahrokh addresses the requirements to file an Investigational Drug Application for a biologic therapy and describes the different sections of the IND with a focus on therapeutic proteins. The presentation ends by providing examples of common deficiencies and mis-steps that Sponsors are likely to make.
Views: 5253 NIHNINDS
Rango Dietrich Release of Batches - 38. Release of Investiga Hörbücher
 
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Views: 13 Feiyr
Rango Dietrich Quality Control - 34. Testing Hörbücher
 
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Rango Dietrich new single Quality Control - 34. Testing with a preview sample. Buy this Hörbücher records from Rango Dietrich - Quality Control - 34. Testing: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Quality+Control+-+34.+Testing Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Quality+Control+-+34.+Testing/ex/s~details,u~10069920,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Quality+Control+-+34.+Testing www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Quality Control - 34. Testing Label: Pharmaudio Guidelines Date: 2014-03-07 Style: Hörbücher ID: 10243649 ISRC: DEAR41413977 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 2 Hörbücher TV
Rango Dietrich Shipping - 47. Transfers of investigational m Hörbücher
 
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Views: 10 Feiyr
1.4. EAEU Pharmaceutical Market: General Principles of Granting a Marketing Authorization
 
15:49
This is a Special Video Series [in #English] describing principles of operation of the Single Market of Human Medicinal Products in the EAEU. We did it to highlight what is happening in this area for foreign companies and other interested parties for whom Russian is not the mother tongue. We hope that the provided information will help you to understand the basics of the EAEU Single Market rules better. The rules are quite robust but need further development to achieve a level equivalent to that effective in developed countries. Currently, great efforts are being made to complement the rules with other documents and procedures. This video deals with a number of important details concerning the Union pharmaceutical legislation.
Views: 291 PhED
Rango Dietrich Quality Control - 34. Testing Hörbücher
 
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Rango Dietrich new single Quality Control - 34. Testing with a preview sample. Buy this Hörbücher records from Rango Dietrich - Quality Control - 34. Testing: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Quality+Control+-+34.+Testing Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Quality+Control+-+34.+Testing/ex/s~details,u~10070311,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Quality+Control+-+34.+Testing www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Quality Control - 34. Testing Label: Pharmaudio Guidelines Date: 2014-03-14 Style: Hörbücher ID: 10245013 ISRC: DEAR41415064 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 3 Feiyr
Rango Dietrich Destruction - 53. Destruction of Unused and o Hörbücher
 
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Rango Dietrich new single Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products with a preview sample. Buy this Hörbücher records from Rango Dietrich - Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products/ex/s~details,u~10070311,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products Label: Pharmaudio Guidelines Date: 2014-03-14 Style: Hörbücher ID: 10245035 ISRC: DEAR41415085 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 12 Feiyr
Rango Dietrich Shipping - 47. Transfers of Investigational M Hörbücher
 
02:01
Rango Dietrich's new single Shipping - 47. Transfers of Investigational Medicinal Products from One Trial Site to Another with a promo sample. Buy this Hörbücher record at: Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Shipping+-+47.+Transfers+of+Investigational+Medicinal+Products+from+One+Trial+Site+to+Another Spotify: http://open.spotify.com/track/4GaxG3t2CsHhyJ7B8vJNve Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Shipping+-+47.+Transfers+of+Investigational+Medicinal+Products+from+One+Trial+Site+to+Another/ex/s~details,u~10069920,p1~mp3/xe/details.html Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Shipping+-+47.+Transfers+of+Investigational+Medicinal+Products+from+One+Trial+Site+to+Another Start your own monetized channel now and earn money with YouTube: http://goo.gl/bJs4Rb Feiyr.com - Sell your Music and eBooks online! Register online for free, upload your songs and start selling them on 300 online stores worldwide. A team of professional label managers will support you during the release process as well as when it comes to setting up promo campaigns. This is how digital music distribution works. Start now! Feiyr: http://www.feiyr.com Feiyr @ Twitter: https://twitter.com/feiyr Feiyr @ Instagram: https://instagram.com/feiyr/ Artist: Rango Dietrich Title: Shipping - 47. Transfers of Investigational Medicinal Products from One Trial Site to Another Date: 2014-03-07 Style: Hörbücher ID: 10243665 ISRC: DEAR41413993 Distributed by: https://www.feiyr.com/digital_music_distribution This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact https://www.feiyr.com/en/contact.html
Views: 9 Hörbücher TV
The Role of Post-Market Pharmacovigilance: Audio Educator
 
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Click here for more Information: http://www.audioeducator.com/pharma-biotech/value-of-post-market-pharmacovigilance-02-24-2015.html The Role of Post-Market Pharmacovigilance to Avoid Serious Adverse Events Presented By: Charles H Pierce Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 199 AudioEducator
Using Oracle's Argus Safety to Comply with ICH E2B(R3)
 
30:12
Learn about the new Individual Case Safety Report (ICSR) international standard and upcoming ICSR reporting changes. -- The new ISO Individual Case Safety Report (ICSR) standard is being finalized in 2011. A major revision of the ICH E2B guideline is progressing based on the new ICSR standard with an ICH step 2 consultation of the ICH E2B(R3) Implementation Guide expected by the end of June 2011. An overview of the proposed changes to the ICSR Final Draft International Standard (FDIS) and its implementation will be discussed, along with the expected changes to the ICSR reporting in the context of the new European pharmacovigilance legislation. Join BioPharm Systems' Andrew Mitchell, EMEA safety and pharmacovigilance practice lead, for this one-hour presentation that will include: -- Discussion of the upcoming ISO Individual Case Safety Report (ICSR) standard known as ICH E2B(R3) -- Electronic reporting of ICSRs and EudraVigilance in the context of the new European pharmacovigilance legislation -- Using Argus Safety to comply with the information and regulations above and how this affects your upgrade planning To view this webinar in its entirety, please visit: http://www.biopharm.com or https://cc.readytalk.com/r/f9da1w6pjn8f. Twitter: http://www.twitter.com/BioPharmSystems Facebook: http://www.facebook.com/BioPharmSystems LinkedIn: http://www.linkedin.com/companies/biopharm-systems-inc Google+: https://plus.google.com/104105608638786200757
Views: 21538 BioPharmSystems
GMP 101 - Intro to Good Manufacturing Practice [WEBINAR]
 
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The quality of starting materials dramatically influences the properties of the final cellular product. Therefore the ultimate success of your cell product depends on the quality of the raw materials used. For the development of cell-based and gene therapy products regulatory authorities may require the use of strict procedures according to GMP regulations https://www.miltenyibiotec.com/products/cell-manufacturing-platform/macs-gmp-portfolio.html Join Nicolas Danzenbächer and his webinar on Good Manufacturing Practice (GMP) and learn more about GMP guidelines in different countries and comparable regulations. MACS Academy: https://www.miltenyibiotec.com/macs-academy Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. Our innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Our technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, cell culture, molecular analysis, and preclinical imaging. Our more than 25 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer, and clinical research areas like hematology, graft engineering, and apheresis. In our commitment to the scientific community, we also offer comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec has more than 2,000 employees in 25 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.
Views: 47965 Miltenyi Biotec
Rango Dietrich Destruction - 53. Destruction of Unused and o Hörbücher
 
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Rango Dietrich's new single Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products with a promo sample. Buy this Hörbücher record at: Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products Spotify: http://open.spotify.com/track/3iyof4206x8JmAqcGjTuXS Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products/ex/s~details,u~10069920,p1~mp3/xe/details.html Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Destruction+-+53.+Destruction+of+Unused+and+or+Returned+Investigational+Medicinal+Products Start your own monetized channel now and earn money with YouTube: http://goo.gl/bJs4Rb Feiyr.com - Sell your Music and eBooks online! Register online for free, upload your songs and start selling them on 300 online stores worldwide. A team of professional label managers will support you during the release process as well as when it comes to setting up promo campaigns. This is how digital music distribution works. Start now! Feiyr: http://www.feiyr.com Feiyr @ Twitter: https://twitter.com/feiyr Feiyr @ Instagram: https://instagram.com/feiyr/ Artist: Rango Dietrich Title: Destruction - 53. Destruction of Unused and or Returned Investigational Medicinal Products Date: 2014-03-07 Style: Hörbücher ID: 10243671 ISRC: DEAR41413999 Distributed by: https://www.feiyr.com/digital_music_distribution This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact https://www.feiyr.com/en/contact.html
Views: 8 Hörbücher TV
Investigational Drug Accountability: Agent Returns
 
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This video from the NCI Pharmaceutical Management Branch (PMB) will review common reasons for returning investigational agents, the return process, how to document returns, and strategies to reduce the need for returns. If you are a person with disability and are having difficulty experiencing the content of these videos, please contact the Pharmaceutical Management Branch (PMB), CTEP/DCTD/NCI/NIH, by telephone 240-276-6575 Monday through Friday from 8:30am to 4:30pm Eastern Time or by emailing [email protected] at any time. The Investigational Drug Accountability Training Videos can also be viewed directly on NCI’s website at http://ctep.cancer.gov/branches/pmb/drug_training_videos.htm.
Investigational Drug Accountability: Local Destruction
 
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This video from the NCI Pharmaceutical Management Branch (PMB) will review when and how to perform local destruction of PMB-supplied agents for Division of Cancer Treatment and Diagnosis (DCTD)-sponsored trials. If you are a person with disability and are having difficulty experiencing the content of these videos, please contact the Pharmaceutical Management Branch (PMB), CTEP/DCTD/NCI/NIH, by telephone 240-276-6575 Monday through Friday from 8:30am to 4:30pm Eastern Time or by emailing [email protected] at any time. The Investigational Drug Accountability Training Videos can also be viewed directly on NCI’s website at http://ctep.cancer.gov/branches/pmb/drug_training_videos.htm.
FOR-DMD Study Webinar (April 2015)
 
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To find the clinical trial on ClinicalTrials.gov please search NCT01603407. Corticosteroids are the only treatment documented to improve strength and increase muscle mass in boys with Duchenne muscular dystrophy (Duchenne). Despite an American Academy of Neurology practice guideline and Cochrane report recommending their use, corticosteroid use is haphazard in timing, dosage schedule, and duration and in some countries not prescribed to most patients. The FOR-DMD study examines the three most commonly prescribed corticosteroid regimens. This webinar includes a presentation of the aims of the FOR-DMD study, along with discussion of why the study is particularly relevant in regard to current/future DMD clinical trials. A parent of one of the FOR-DMD study subjects was also available for participant questions.
PharmaFORUM Webcast International "eCTD worldwide" 5 July 2018
 
01:48:07
Would you like to learn more about our webcasts? No problem! Please find more information at www.forum-institut.com/pharma-webcast-international On 5 July 2018, Remco Munnik, Regulatory Information Director at Asphalion, gave a lecture on eSubmission in the PharmaFORUM Webcast international series. Remco made clear that NeeS will be phased out as from January 2019 in Europe, from which date eCTD will be mandatory for all submissions and all application types. He mainly addressed the current V 3.2 specifications but also gave an overview of eCTD version 4.0, which might be in optional use in the centralised procedure as from 2020. He not only addressed the regulatory requirements in the ICH region but also gave insights into (e)submission requirements in LATAM, Asia, the GCC states in the Middle East, South Africa and other countries. It became quite clear that most countries are switching to eSubmission and that the eCTD is the most widely used format. Remco also included some information on the SPOR project and the first steps with regard to ‘referentials’ and ‘organisations’. He recommended that everybody actively participate in this process. Author: Dr. Henriette Wolf-Klein [email protected]
Views: 61 FORUMInstitut
GMP for Phase 1 Products
 
01:46:48
This Video will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected]
Ankur Arora Murder Case Full Movie | Hindi Movies 2019 Full Movie | Kay Kay Menon | Tisca Chopra
 
02:08:22
#HindiMovies2019 #HindiDubbedMovies2019 #BollywoodMovies2019 #KayKayMenon #TiscaChopra Ankur Arora Murder Case which takes up an urgent and disturbing issue of death during surgery and is based on a real-life incident where a boy dies on the operation table due to medical negligence. For Latest Updates, follow us on Facebook http://www.facebook.com/bollykick G + http://www.google.com/+bollykick Twitter http://www.twitter.com/bollykick Romesh (Arjun Mathur) was a young medical intern who dared to dream. He was in awe of Dr. Asthana (Kay Kay Menon), the Chief of Surgery of the Shekhawat General Hospital. All he wanted was to be like him. He lived in with Riya, his co-intern and the love of his life.However, when an eight-year old boy, Ankur dies due to Dr.Asthana's medical negligence, Romesh realises that a good surgeon is not necessarily a good person.Together with Ankur's mother Nandita, Dr Romesh sets out on a turbulent journey to fight for what is right. A fight for justice against his mentor, the hospital and the love of his life
Views: 13144283 Bolly Kick
2.1. Russian Regulatory Framework: Pre-authorization Issues of Placing Pharmaceuticals on the Market
 
18:10
This is a Special Video Series [in #English] describing principles of operation of the Russian Market of Human Medicinal Products. We did it to highlight what is happening in this area for foreign companies and other interested parties for whom Russian is not the mother tongue. This video describes general regulatory framework and main pre-authorization issues, including GMP certification, non-clinical, and clinical testing. We hope that the provided information will help you to understand the basics of placing medicinal products for human use on Russian pharmaceutical market. The rules are not that stringent but rather protective. At the same time, great efforts are being made to develop a robust rules and procedures in the EAEU legal framework.
Views: 345 PhED
Rango Dietrich - Destruction - 55. Certificate of Destruction [Hörbücher]
 
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Rango Dietrich's new single Destruction - 55. Certificate of Destruction with a promo sample. Buy this Hörbücher record at: Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Destruction+-+55.+Certificate+of+Destruction Spotify: http://open.spotify.com/track/2bXDyxIg5DkwSBBoqQlMPA Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Destruction+-+55.+Certificate+of+Destruction/ex/s~details,u~10069920,p1~mp3/xe/details.html Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Destruction+-+55.+Certificate+of+Destruction Start your own monetized channel now and earn money with YouTube: http://goo.gl/bJs4Rb Feiyr.com - Sell your Music and eBooks online! Register online for free, upload your songs and start selling them on 300 online stores worldwide. A team of professional label managers will support you during the release process as well as when it comes to setting up promo campaigns. This is how digital music distribution works. Start now! Feiyr: http://www.feiyr.com Feiyr @ Twitter: https://twitter.com/feiyr Feiyr @ Instagram: https://instagram.com/feiyr/ Artist: Rango Dietrich Title: Destruction - 55. Certificate of Destruction Date: 2014-03-07 Style: Hörbücher ID: 10243673 ISRC: DEAR41414001 Distributed by: https://www.feiyr.com/digital_music_distribution This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact https://www.feiyr.com/en/contact.html
Views: 21 Hörbücher TV
U.S. Food and Drug Administration | Wikipedia audio article
 
53:07
This is an audio version of the Wikipedia Article: U.S. Food and Drug Administration 00:01:57 1 Organizational chart 00:02:07 2 Location 00:03:00 3 Regional facilities 00:05:53 4 Scope and funding 00:08:14 5 Regulatory programs 00:09:46 5.1 Canada-United States Regulatory Cooperation Council 00:10:43 5.2 Food and dietary supplements 00:11:51 5.2.1 "FDA-Approved" vs. "FDA-Accepted in Food Processing" 00:12:40 5.3 Medications 00:13:18 5.3.1 New medications 00:14:58 5.3.1.1 Advertising and promotion 00:15:51 5.3.1.2 Postmarket safety surveillance 00:17:25 5.3.2 Generic drugs 00:18:14 5.3.2.1 Generic drug scandal 00:20:36 5.3.3 Over-the-counter drugs 00:21:13 5.3.4 Ebola treatment 00:21:46 5.4 Vaccines, blood and tissue products, and biotechnology 00:22:56 5.5 Medical and radiation-emitting devices 00:24:07 5.5.1 "FDA-Cleared" vs "FDA-Approved" 00:24:47 5.6 Cosmetics 00:26:14 5.7 Veterinary products 00:26:56 5.8 Tobacco products 00:28:49 5.9 Regulation of living organisms 00:29:40 6 Science and research programs 00:30:17 7 Data management 00:30:38 8 History 00:37:39 8.1 Historical first: FDA and Endo Pharmaceutical's Opana ER (2017) 00:38:05 9 21st century reforms 00:38:15 9.1 Critical Path Initiative 00:38:47 9.2 Patients' rights to access unapproved drugs 00:40:14 9.3 Post-marketing drug safety monitoring 00:42:50 9.4 Pediatric drug testing 00:45:31 9.5 Priority review voucher (PRV) 00:46:28 9.6 Rules for generic biologics 00:47:44 9.7 Mobile medical applications 00:48:16 10 Criticisms 00:51:04 11 See also Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago. Learning by listening is a great way to: - increases imagination and understanding - improves your listening skills - improves your own spoken accent - learn while on the move - reduce eye strain Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone. You can find other Wikipedia audio articles too at: https://www.youtube.com/channel/UCuKfABj2eGyjH3ntPxp4YeQ You can upload your own Wikipedia articles through: https://github.com/nodef/wikipedia-tts "The only true wisdom is in knowing you know nothing." - Socrates SUMMARY ======= The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, who took over in May 2017.The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
Views: 15 wikipedia tts
Day 1 - Appropriate Use of Drug Therapies for Osteoporotic Fracture Prevention
 
07:37:22
More than 10 million people in the United States have osteoporosis, a skeletal disorder that causes bones to become weak and fragile as a result of low bone mass. The condition makes people more susceptible to fractures, which can impair their ability to live independently and even threaten their lives. The social and economic burden of osteoporotic fractures is substantial. Reducing osteoporosis prevalence and hip fracture incidence are among the major objectives of Healthy People 2020, the U.S. Department of Health & Human Services’ national health promotion and disease prevention initiative. Lifestyle changes—including getting adequate nutrition and regular exercise, quitting tobacco use, limiting alcohol use, and preventing falls—can help reduce a person’s risk of osteoporotic fractures. However, medications may be prescribed to prevent fractures if a person has very low bone mineral density or has experienced a prior fragility fracture. The U.S. Food and Drug Administration has approved several types of drugs to prevent osteoporotic fractures. Clinical guidelines by various medical organizations recommend bisphosphonates (BPs) as a first line of treatment for most people who have osteoporosis. BPs are effective for short-term use (up to 3–5 years) by people who are at high risk of fracture. However, the benefits and risks of longer-term treatment are less clear. Reports of rare but serious adverse events such as atypical femoral fractures and osteonecrosis (death of cells) of the jaw have raised questions about the safety of osteoporosis drug use, especially in people who use the drugs for more than 3–5 years or who had a low risk of fracture when they began treatment. Research Challenges There is a gap in scientific data about the appropriate long-term use of many osteoporosis drugs. There are uncertainties about which people will benefit or may be harmed if they take the drugs long-term. Public concern about these and other unanswered questions has coincided with a significant decrease in use of osteoporosis drugs and a leveling off in what had been a promising decline in the incidence of osteoporotic fractures. These changes have raised concerns within medical and professional communities that many people who might need the drugs are not being prescribed them, and those who are prescribed them are not taking them. In addition, evidence is limited regarding the initiation and length of “drug holidays” (a medical practice in which a patient stops taking medications for a period of time and then resumes treatment again, if the patient or their doctor believes it could be in their best interests), whether stopping treatment reduces the risk of serious adverse events while maintaining fracture prevention benefit, and which individuals should change treatments instead of simply taking a drug holiday from their current medication. Innovative research strategies are needed to address these knowledge gaps and to help better inform individuals and physicians in their decision-making about osteoporosis treatment. Workshop Goals This P2P workshop will assess the available scientific evidence to better understand the appropriate use of drugs for osteoporotic fracture prevention, specifically addressing the following questions: What are the benefits and risks (including major adverse events) of osteoporotic drugs with short-term use (from first-use up to 3–5 years of treatment)? What factors influence outcomes? What are the benefits and risks of osteoporotic drugs over the longer term (for treatment periods longer than 3–5 years)? What factors influence outcomes? Do drug holidays improve outcomes? What patient and clinician factors impact the use of and adherence to osteoporotic drugs? Workshop Sponsors National Institute on Aging National Institute of Arthritis and Musculoskeletal and Skin Diseases NIH Office of Disease Prevention
Views: 195 NIH ODP
Rango Dietrich Recalls and Returns - Returns - 51. Return On Hörbücher
 
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Rango Dietrich new single Recalls and Returns - Returns - 51. Return On Agreed Conditions with a preview sample. Buy this Hörbücher records from Rango Dietrich - Recalls and Returns - Returns - 51. Return On Agreed Conditions: Rango Dietrich at Amazon: http://www.amazon.de/s/field-keywords=Rango+Dietrich%20Recalls+and+Returns+-+Returns+-+51.+Return+On+Agreed+Conditions Rango Dietrich at Djshop.de: http://www.djshop.de/Download-Rango+Dietrich-Recalls+and+Returns+-+Returns+-+51.+Return+On+Agreed+Conditions/ex/s~details,u~10070311,p1~mp3/xe/details.html Rango Dietrich at Djtunes.com: http://www.djtunes.com/music?view=tracks&sorf=relevance&searchq=Rango+Dietrich+Recalls+and+Returns+-+Returns+-+51.+Return+On+Agreed+Conditions www.Feiyr.com - Load up your music! Distribute your music online. Easy, fast and competetive. We publish your music, audiobooks, eBooks and other audio productions worldwide on more than 300 Download Shops and music portals like iTunes, Amazon, Spotify, Google Play, Napster, Beatport, DJtunes.com, Deezer, Djshop, Youtube, Xbox Music, Juno Download and many more. In addition, we now also publish your books as eBooks. Start selling your music today! http://www.feiyr.com/c/en/partner Rango Dietrich on Facebook: http://www.google.de/#&q=Rango+Dietrich+facebook Rango Dietrich on Wikipedia: http://www.google.de/#&q=Rango+Dietrich+wikipedia Rango Dietrich on Twitter: http://www.google.de/#&q=Rango+Dietrich+twitter Rango Dietrich on Soundcloud: http://www.google.de/#&q=Rango+Dietrich+soundcloud Track info: Artist: Rango Dietrich Title: Recalls and Returns - Returns - 51. Return On Agreed Conditions Label: Pharmaudio Guidelines Date: 2014-03-14 Style: Hörbücher ID: 10245033 ISRC: DEAR41415083 This video was published on YouTube with the authorization of Pharmaudio Guidelines. If you want to request a delete of this video, please contact http://www.feiyr.com
Views: 5 Feiyr
Criticism of the Food and Drug Administration | Wikipedia audio article
 
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This is an audio version of the Wikipedia Article: Criticism of the Food and Drug Administration 00:01:09 1 Charges of over-regulation 00:01:26 1.1 Alleged problems in the drug approval process 00:04:18 1.2 Allegations that FDA regulation causes higher drug prices 00:06:18 1.3 Allegations of censorship in food and drug labeling 00:07:36 2 Charges of under-regulation 00:08:31 2.1 Allegations that the FDA covered up exportation of unsafe products 00:09:38 2.2 Allegations that unsafe drugs are approved 00:12:19 2.3 Allegations that unsafe food additives and processing technologies are approved 00:16:22 3 Charges of FDA bias 00:16:32 3.1 Allegations of undue pharmaceutical industry influence 00:16:44 3.1.1 Pressure to allow pharmaceuticals 00:18:28 3.1.2 Viewing the pharmaceutical industry as FDA clients 00:20:39 3.1.3 Bias toward more expensive drug 00:22:15 3.2 Allegations of bias against gay men in blood donation process 00:24:13 3.3 Criticism of FDA's rejection of medical cannabis 00:25:25 3.4 Allegations regarding management and FDA scientists 00:25:55 4 See also Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago. Learning by listening is a great way to: - increases imagination and understanding - improves your listening skills - improves your own spoken accent - learn while on the move - reduce eye strain Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone. You can find other Wikipedia audio articles too at: https://www.youtube.com/channel/UCuKfABj2eGyjH3ntPxp4YeQ You can upload your own Wikipedia articles through: https://github.com/nodef/wikipedia-tts "The only true wisdom is in knowing you know nothing." - Socrates SUMMARY ======= Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation. The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from animals sold as pets to donations of human blood and tissue.A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the FDA system for ensuring the safety of drugs on the American market. Overall, the authors called for an increase in the regulatory powers, funding, and independence of the FDA.
Views: 5 wikipedia tts
US Food and Drug Administration | Wikipedia audio article
 
53:07
This is an audio version of the Wikipedia Article: US Food and Drug Administration 00:01:57 1 Organizational chart 00:02:07 2 Location 00:03:00 3 Regional facilities 00:05:53 4 Scope and funding 00:08:14 5 Regulatory programs 00:09:46 5.1 Canada-United States Regulatory Cooperation Council 00:10:43 5.2 Food and dietary supplements 00:11:51 5.2.1 "FDA-Approved" vs. "FDA-Accepted in Food Processing" 00:12:40 5.3 Medications 00:13:18 5.3.1 New medications 00:14:58 5.3.1.1 Advertising and promotion 00:15:51 5.3.1.2 Postmarket safety surveillance 00:17:25 5.3.2 Generic drugs 00:18:14 5.3.2.1 Generic drug scandal 00:20:36 5.3.3 Over-the-counter drugs 00:21:13 5.3.4 Ebola treatment 00:21:46 5.4 Vaccines, blood and tissue products, and biotechnology 00:22:56 5.5 Medical and radiation-emitting devices 00:24:07 5.5.1 "FDA-Cleared" vs "FDA-Approved" 00:24:47 5.6 Cosmetics 00:26:14 5.7 Veterinary products 00:26:56 5.8 Tobacco products 00:28:49 5.9 Regulation of living organisms 00:29:40 6 Science and research programs 00:30:17 7 Data management 00:30:38 8 History 00:37:39 8.1 Historical first: FDA and Endo Pharmaceutical's Opana ER (2017) 00:38:05 9 21st century reforms 00:38:15 9.1 Critical Path Initiative 00:38:47 9.2 Patients' rights to access unapproved drugs 00:40:14 9.3 Post-marketing drug safety monitoring 00:42:50 9.4 Pediatric drug testing 00:45:31 9.5 Priority review voucher (PRV) 00:46:28 9.6 Rules for generic biologics 00:47:44 9.7 Mobile medical applications 00:48:16 10 Criticisms 00:51:04 11 See also Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago. Learning by listening is a great way to: - increases imagination and understanding - improves your listening skills - improves your own spoken accent - learn while on the move - reduce eye strain Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone. You can find other Wikipedia audio articles too at: https://www.youtube.com/channel/UCuKfABj2eGyjH3ntPxp4YeQ You can upload your own Wikipedia articles through: https://github.com/nodef/wikipedia-tts "The only true wisdom is in knowing you know nothing." - Socrates SUMMARY ======= The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, who took over in May 2017.The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
Views: 4 wikipedia tts
Food and Drug Administration (United States) | Wikipedia audio article
 
53:07
This is an audio version of the Wikipedia Article: Food and Drug Administration (United States) 00:01:57 1 Organizational chart 00:02:07 2 Location 00:03:00 3 Regional facilities 00:05:53 4 Scope and funding 00:08:14 5 Regulatory programs 00:09:46 5.1 Canada-United States Regulatory Cooperation Council 00:10:43 5.2 Food and dietary supplements 00:11:51 5.2.1 "FDA-Approved" vs. "FDA-Accepted in Food Processing" 00:12:40 5.3 Medications 00:13:18 5.3.1 New medications 00:14:58 5.3.1.1 Advertising and promotion 00:15:51 5.3.1.2 Postmarket safety surveillance 00:17:25 5.3.2 Generic drugs 00:18:14 5.3.2.1 Generic drug scandal 00:20:36 5.3.3 Over-the-counter drugs 00:21:13 5.3.4 Ebola treatment 00:21:46 5.4 Vaccines, blood and tissue products, and biotechnology 00:22:56 5.5 Medical and radiation-emitting devices 00:24:07 5.5.1 "FDA-Cleared" vs "FDA-Approved" 00:24:47 5.6 Cosmetics 00:26:14 5.7 Veterinary products 00:26:56 5.8 Tobacco products 00:28:49 5.9 Regulation of living organisms 00:29:40 6 Science and research programs 00:30:17 7 Data management 00:30:38 8 History 00:37:39 8.1 Historical first: FDA and Endo Pharmaceutical's Opana ER (2017) 00:38:05 9 21st century reforms 00:38:15 9.1 Critical Path Initiative 00:38:47 9.2 Patients' rights to access unapproved drugs 00:40:14 9.3 Post-marketing drug safety monitoring 00:42:50 9.4 Pediatric drug testing 00:45:31 9.5 Priority review voucher (PRV) 00:46:28 9.6 Rules for generic biologics 00:47:44 9.7 Mobile medical applications 00:48:16 10 Criticisms 00:51:04 11 See also Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago. Learning by listening is a great way to: - increases imagination and understanding - improves your listening skills - improves your own spoken accent - learn while on the move - reduce eye strain Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone. You can find other Wikipedia audio articles too at: https://www.youtube.com/channel/UCuKfABj2eGyjH3ntPxp4YeQ You can upload your own Wikipedia articles through: https://github.com/nodef/wikipedia-tts "The only true wisdom is in knowing you know nothing." - Socrates SUMMARY ======= The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, who took over in May 2017.The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
Views: 4 Subhajit Sahu
United States Food and Drug Administration | Wikipedia audio article
 
53:07
This is an audio version of the Wikipedia Article: United States Food and Drug Administration 00:01:57 1 Organizational chart 00:02:07 2 Location 00:03:00 3 Regional facilities 00:05:53 4 Scope and funding 00:08:14 5 Regulatory programs 00:09:46 5.1 Canada-United States Regulatory Cooperation Council 00:10:43 5.2 Food and dietary supplements 00:11:51 5.2.1 "FDA-Approved" vs. "FDA-Accepted in Food Processing" 00:12:40 5.3 Medications 00:13:18 5.3.1 New medications 00:14:58 5.3.1.1 Advertising and promotion 00:15:51 5.3.1.2 Postmarket safety surveillance 00:17:25 5.3.2 Generic drugs 00:18:14 5.3.2.1 Generic drug scandal 00:20:36 5.3.3 Over-the-counter drugs 00:21:13 5.3.4 Ebola treatment 00:21:46 5.4 Vaccines, blood and tissue products, and biotechnology 00:22:56 5.5 Medical and radiation-emitting devices 00:24:07 5.5.1 "FDA-Cleared" vs "FDA-Approved" 00:24:47 5.6 Cosmetics 00:26:14 5.7 Veterinary products 00:26:56 5.8 Tobacco products 00:28:49 5.9 Regulation of living organisms 00:29:40 6 Science and research programs 00:30:17 7 Data management 00:30:38 8 History 00:37:39 8.1 Historical first: FDA and Endo Pharmaceutical's Opana ER (2017) 00:38:05 9 21st century reforms 00:38:15 9.1 Critical Path Initiative 00:38:47 9.2 Patients' rights to access unapproved drugs 00:40:14 9.3 Post-marketing drug safety monitoring 00:42:50 9.4 Pediatric drug testing 00:45:31 9.5 Priority review voucher (PRV) 00:46:28 9.6 Rules for generic biologics 00:47:44 9.7 Mobile medical applications 00:48:16 10 Criticisms 00:51:04 11 See also Listening is a more natural way of learning, when compared to reading. Written language only began at around 3200 BC, but spoken language has existed long ago. Learning by listening is a great way to: - increases imagination and understanding - improves your listening skills - improves your own spoken accent - learn while on the move - reduce eye strain Now learn the vast amount of general knowledge available on Wikipedia through audio (audio article). You could even learn subconsciously by playing the audio while you are sleeping! If you are planning to listen a lot, you could try using a bone conduction headphone, or a standard speaker instead of an earphone. You can find other Wikipedia audio articles too at: https://www.youtube.com/channel/UCuKfABj2eGyjH3ntPxp4YeQ You can upload your own Wikipedia articles through: https://github.com/nodef/wikipedia-tts "The only true wisdom is in knowing you know nothing." - Socrates SUMMARY ======= The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription Drug User Fee Act.The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act, which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Public Health Service Act and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers, cellular phones, condoms and control of disease on products ranging from certain household pets to sperm donation for assisted reproduction. The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the current commissioner, who took over in May 2017.The FDA has its headquarters in unincorporated White Oak, Maryland. The agency also has 223 field offices and 13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico. In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom.
Views: 3 wikipedia tts