• A guide to new medicines approval

    Approvals from regulatory authorities such as the U.S. Food and Drug Administration (FDA) are essential to getting medicines to patients. If you were ever curious about what an approval actually entails, check out this short animation in which our Global Head of Drug Regulatory Affairs, Rob Kowalski, gives an overview. © 2015 Novartis AG

    published: 30 Jul 2015
  • Need of regulatory approval to set up an Indian company.

    Download Arinjay Academy app at : - https://play.google.com/store/apps/details?id=com.arinjayacademy You can access our content at https://www.arinjayacademy.com/learn Practice Accounts Exercise Class XII at - https://www.arinjayacademy.com/learn/Accounts-Class-XII?tab=3 Practice Maths Exercise Class VI at - https://www.arinjayacademy.com/learn/MathsClassVI?tab=3 Practice Maths Exercise Class VII at - https://www.arinjayacademy.com/learn/Maths--Class---7-?tab=3 Practice Hindi Exercise Class VI at - https://www.arinjayacademy.com/learn/Hindi---Class-6--?tab=3 Practice Economics Exercise Class XII at - https://www.arinjayacademy.com/learn/Economics---Class-12?tab=3

    published: 19 Jun 2012
  • BIOCASSAVA PLUS RECEIVES REGULATORY APPROVAL IN 2017 -BrosTV

    Cassava is a root vegetable, high in carbohydrates, that forms a major staple food in the developing world, providing a basic diet for over half a billion people. It is among the most drought-tolerant crops, able to grow on marginal soils. However, this vegetable has a number of downsides. With toxins including cyanide, improper preparation can lead to acute intoxication and goiters, or even ataxia and paralysis. It is also a poor source of protein and may cause protein-energy malnutrition, unless consumed as part of a more balanced and varied diet. Two diseases – Cassava Mosaic Disease (affecting the edible leaves) and Brown Streak Disease (which rots and kills the roots) – have caused devastating famines in the past. The latter is especially troublesome in coastal East Africa and around...

    published: 08 Mar 2017
  • 7D Surgical - Regulatory Approval

    7D Surgical has launched an innovative Machine-vision Image Guided Surgery system for spine surgery. This new technology employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. The 7D Surgical System can easily register spinal surgery patients automatically in an unprecedented entire workflow time of less than 20 seconds, while also eliminating intraoperative radiation. Our navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and along with foot pedal interaction of the software, puts the surgeon in total control. FDA 510(k) clearance and Health Canada approved for the Spinal Applicatio...

    published: 23 Jan 2017
  • How Does The FDA Approve New Drugs?

    Is China Fueling The Drug War? http://testu.be/1GzTYHN Subscribe! http://bitly.com/1iLOHml The Food and Drug Administration is one of the world's strictest regulatory agencies. So, how do drugs get approved for use in the U.S.? Learn More: Drug Safety/Drug Approval Process http://www.fda.gov/NewsEvents/Testimony/ucm161673.htm "Modern drugs provide unmistakable and significant health benefits." House overwhelmingly passes bill to speed FDA drug approvals http://www.washingtonpost.com/blogs/wonkblog/wp/2015/07/10/house-overwhelmingly-passes-bill-to-speed-fda-drug-approvals/ "A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning." Novel New Drugs 2013 Summary htt...

    published: 20 Jul 2015
  • Colorants in Devices: Integrated Strategies Toward Regulatory Approval

    Click here to register for free and to view the entire webinar: http://xtalks.com/Colorants-Medical-Devices.ashx?utm_source=YouTube&utm_medium=Teaser&utm_campaign=XTO787_Arazy_Toxikon%20 Speakers: Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc. John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation A challenge common to all medical device manufacturers, regardless of their products’ level of risk, indications of use, or technical specifications is pre-market approval. An integrated strategy towards regulatory approval is the most critical step for the future of any medical device. Leading regulatory consultancy Arazy Group and one of the world’s premier accredited research and testing facilities, Toxikon Corporation, ...

    published: 28 Jul 2015
  • How to obtain regulatory approval of food supplements & novel foods in the EU

    Dr Wilkinson who has over twenty years experience in the research & development of botanicals and regulatory affairs, outlines the approval steps for novel foods, nutraceuticals, exotic foods and supplements in the EU

    published: 23 Oct 2010
  • Covidien's Solitaire™ FR Revascularization Device Receives Regulatory Approval in Brazil

    Covidien's Solitaire FR device is used to restore blood flow to the brain in patients suffering acute ischemic stroke. http://www.businesswire.com/news/home/20120719005452/en/Covidien%E2%80%99s-Solitaire%E2%84%A2-FR-Revascularization-Device-Receives-Regulatory

    published: 19 Jul 2012
  • FDA Approved: How the FDA Approval Process Works

    Explains the process that drug makers have to go through to receive approval from the Food and Drug Administration.

    published: 28 Dec 2012
  • Webinar: Regulatory Approval of Aging Infrastructure Programs

    Regulatory Approval of Aging Infrastructure Programs Presented by Dr. Richard Brown, Principal Engineer with Exponent and Director of its Engineering Management Consulting September 27, 2016 11:00 a.m. PDT | 2:00 p.m. EDT Learn best practices for gaining regulatory approval of your aging infrastructure programs. Dr. Richard Brown, a leading expert in power distribution reliability and regulatory affairs, will walk you through: Aging infrastructure and rate cases Justifying proactive replacement programs Engaging regulators and commission staff Case Study: Aging Cables About Dr. Brown Dr. Richard E. Brown is the Practice Director for the Engineering Management Consulting practice of Exponent. He has published more than 90 technical articles and is author of the books Electric Power Distr...

    published: 27 Sep 2016
  • Putting adoptive T cell therapy on the path to regulatory approval

    Visit http://www.ecancer.org for more. Prof Ribas (UCLA Jonsson Comprehensive Cancer Center, Los Angeles, USA) talks to ecancertv at TAT 2015 about adoptive T-cell therapy approaches and their current stage of clinical development. He also discusses the challenges of moving this personalised approach to cancer therapy into the clinic.

    published: 20 Mar 2015
  • Non-Alcoholic Steatohepatitis (NASH) Covance Webinar: Progress Toward Regulatory Approval Pathways

    Learn more about the challenges of this "silent" liver disease along with therapeutic strategies to accelerate both clinical and regulatory efforts for this critical unmet medical need in Non-Alcoholic Steatohepatitis (NASH) studies.

    published: 19 Jun 2015
  • The FDA Drug Development Process: GLP, GMP and GCP Regulations

    This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.com Help us caption & translate this vid...

    published: 24 May 2016
  • Four Cubesats Snuck into Orbit Without Regulatory Approval, FCC Says

    Four unauthorized cubesats apparently launched atop this Indian Polar Satellite Launch Vehicle rocket in January 2018, according to the U.S.Federal Communications Commission.Concerns about space junk and satellite-launch regulations are swirling after the Federal Communications Commission (FCC) alleged that a U.S.company launched four tiny satellites without permission.As first reported in IEEE Spectrum, four miniature satellites called SpaceBee-1, 2, 3, and 4 launched to orbit from India aboard a Polar Satellite Launch Vehicle (PSLV) rocket in January, along with several dozen other cubesats and an Indian Earth-observing spacecraft.Launch documents did not identify the SpaceBees' operator.But the documents' description of the four satellites matches information that a California-based com...

    published: 16 Mar 2018
  • Accelerating the regulatory approval of autonomous vehicles

    Presentation by Alex Flamant at Transpolitica 2016. There are currently 3500 auto related deaths a day globally. Smart, connected, autonomous vehicles could significantly reduce that number. That’s a compelling reason to accelerate the regulatory approval of autonomous vehicles. The session was chaired by David Wood and the camera was operated by Kiran Manam. For more information about Notion Capital, see http://www.notioncapital.com/about/. For more information about the event Transpolitica 2016, see https://www.meetup.com/London-Futurists/events/233996384/. For more information about Transpolitica, see https://transpolitica.org/.

    published: 19 Dec 2016
  • Design for Regulatory Approval as Carefully as You Design Your Automation - Keith Rodwell

    Raytheon, a multinational Defense and Cybersecurity industry leader, is on a Digital Transformation journey including expanding its use of compliant Cloud based Service Providers. Embracing Digital Transformation requires cultural shifts, regulatory considerations and new approaches toward driving Regulatory Compliance. This presentation will cover several IT Security and Export/Import compliance challenges companies will likely face as they prepare for regulatory approval for the use of cloud based capabilities. Ensuring you start dialogs with your governing partners, with the right tenor and focus, will support the adoption of durable solutions and configurations, regardless of any particular entity’s needs. This presentation will cover architectural and service owner perspectives on n...

    published: 21 Dec 2017
  • Kiran Mazumdar-Shaw on Receiving Regulatory Approval for Insulin Glargine in Japan.

    Kiran Mazumdar- Shaw speaking on Biocon’s landmark achievement of receiving Regulatory Approval for its first Insulin Glargine from PMDA, MHLW in Japan. Proud moment for Biocon, Endorsement of our Capability in Biosimilars and Commitment to Quality. First Biosimilar From India to be approved in Japan. Prefilled Pen to be launched in Q1 FY17.

    published: 29 Mar 2016
  • News Update: AT&T close to regulatory approval for $2.35B deal

    AT&T (T) is said to be close to receiving approval from regulators for the proposed $2.35B purchase of rural U.S. wireless licenses from Verizon Wireless, a joint venture between Verizon Communications (VZ) and Vodafone (VOD), the Wall Street Journal reports. People familiar with the matter say that after a prolonged review, a vote in the FCC could happen in coming weeks.

    published: 17 Jun 2010
  • Is regulatory approval of oncology drugs complicated in USA? - Bradford Goodwin

    In USA regulatory approval of drugs is very restrictive. It requires detailed research and investigation: preclinical and clinical as well. It can be 10 or 20 years for an oncology drug to go from a lab to the market. Wprowadzanie na rynek wszystkich leków w USA wymaga przedstawienia wyników wielu szczegółowych badań, także przedklinicznych i klinicznych. Wyprowadzenie preparatu z laboratorium na rynek może zająć nawet 20 lat. Więcej ciekawych publikacji odnajdziesz na portalu biotechnologia.pl ©Biotechnologia.pl/Laborant.pl

    published: 14 Aug 2014
  • BUYING INTO BRITAM: Deal yet to get regulatory approval

    BUYING INTO BRITAM: Deal yet to get regulatory approval SUBSCRIBE to our YouTube channel for more great videos: https://www.youtube.com/ Follow us on Twitter: https://twitter.com/KTNNews Like us on Facebook: https://www.facebook.com/KTNNewsKenya For more great content go to http://www.standardmedia.co.ke/ktnnews and download our apps: http://std.co.ke/apps/#android KTN News is a leading 24-hour TV channel in Eastern Africa with its headquarters located along Mombasa Road, at Standard Group Centre. This is the most authoritative news channel in Kenya and beyond.

    published: 27 Sep 2017
  • The regulatory framework in the European Union (EU) for approval of new antibacterials:

    Speaker: Mair Powell, Infectious Disease Working Party, EMA The regulatory framework in the European Union (EU) for approval of new antibacterials: underlying principles, available options, impact on development of new, effective antibacterials and considerations to have rapid authorisations Session 1: Approval of new antibacterials Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem

    published: 04 Dec 2013
  • BitFlyer Receives Regulatory Approval to Operate in the European Union

    BitFlyer Receives Regulatory Approval to Operate in the European Union Europe has always been a relatively tepid market when it comes to Bitcoin and other cryptocurrencies. It almost seems as if there is a genuine disinterest in what this new form of money can mean for E... ************************************* Thank fof watching. Don't forget subscriber my channel.

    published: 25 Jan 2018
  • PSTI Cell Manufacturing Facility Receives German Regulatory Approval of 3D Manufacturing Process

    HAIFA, Israel, Jan. 23, 2014 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell product candidates, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), Germany's health authority, to supply cells from its advanced, fully automated, and proprietary 3D cell expansion manufacturing platform implemented at its new state-of-the-art GMP facility. Pluristem's new manufacturing facility has the capability to efficiently produce over 150,000 doses of PLX cells annually, which potentially translates into significant economic value. This marks the first regulatory approval of Pluristem's new facility where the company has implemented its large scale 3D bioreactor expansion of placental-derived mesenchymal-like A...

    published: 24 Jan 2014
  • St. Jude Medical Announces European Regulatory Approval of Implanted Neurostimulation Device

    The St. Jude Medical Genesis(TM) neurostimulation system is the only fully implantable neurostimulation system that is approved in Europe for peripheral nerve stimulation (PNS) of the occipital nerves for the management of the pain and disability for patients diagnosed with intractable chronic migraine. PNS for intractable chronic migraine involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and connected to the Genesis neurostimulator, a pacemaker-like device, which produces the pulses of stimulation. Animation provided by St. Jude Medical, Inc. (Business Wire) Business Wire Press Release available: http://www.businesswire.com/news/home/201109060...

    published: 07 Sep 2011
developed with YouTube
A guide to new medicines approval
2:20

A guide to new medicines approval

  • Order:
  • Duration: 2:20
  • Updated: 30 Jul 2015
  • views: 10307
videos
Approvals from regulatory authorities such as the U.S. Food and Drug Administration (FDA) are essential to getting medicines to patients. If you were ever curious about what an approval actually entails, check out this short animation in which our Global Head of Drug Regulatory Affairs, Rob Kowalski, gives an overview. © 2015 Novartis AG
https://wn.com/A_Guide_To_New_Medicines_Approval
Need of regulatory approval to set up an Indian company.
3:48

Need of regulatory approval to set up an Indian company.

  • Order:
  • Duration: 3:48
  • Updated: 19 Jun 2012
  • views: 43
videos
Download Arinjay Academy app at : - https://play.google.com/store/apps/details?id=com.arinjayacademy You can access our content at https://www.arinjayacademy.com/learn Practice Accounts Exercise Class XII at - https://www.arinjayacademy.com/learn/Accounts-Class-XII?tab=3 Practice Maths Exercise Class VI at - https://www.arinjayacademy.com/learn/MathsClassVI?tab=3 Practice Maths Exercise Class VII at - https://www.arinjayacademy.com/learn/Maths--Class---7-?tab=3 Practice Hindi Exercise Class VI at - https://www.arinjayacademy.com/learn/Hindi---Class-6--?tab=3 Practice Economics Exercise Class XII at - https://www.arinjayacademy.com/learn/Economics---Class-12?tab=3
https://wn.com/Need_Of_Regulatory_Approval_To_Set_Up_An_Indian_Company.
BIOCASSAVA PLUS RECEIVES REGULATORY APPROVAL IN 2017 -BrosTV
2:16

BIOCASSAVA PLUS RECEIVES REGULATORY APPROVAL IN 2017 -BrosTV

  • Order:
  • Duration: 2:16
  • Updated: 08 Mar 2017
  • views: 80
videos
Cassava is a root vegetable, high in carbohydrates, that forms a major staple food in the developing world, providing a basic diet for over half a billion people. It is among the most drought-tolerant crops, able to grow on marginal soils. However, this vegetable has a number of downsides. With toxins including cyanide, improper preparation can lead to acute intoxication and goiters, or even ataxia and paralysis. It is also a poor source of protein and may cause protein-energy malnutrition, unless consumed as part of a more balanced and varied diet. Two diseases – Cassava Mosaic Disease (affecting the edible leaves) and Brown Streak Disease (which rots and kills the roots) – have caused devastating famines in the past. The latter is especially troublesome in coastal East Africa and around the eastern lakes, where it is the single biggest threat to food security. In addition, cassava has a poor shelf life of only two to three days. In 2003, Bill Gates announced the "Grand Challenges in Global Health", a $200m effort to address healthcare and extreme poverty in the developing world. The following year, his charity – the Bill & Melinda Gates Foundation – selected BioCassava Plus, a biotechnology project to improve cassava. With genetic engineering and a range of crop breeding techniques, it would be possible to enrich the protein content, reduce the vegetable's toxicity, fortify it with vitamins A and E, iron and zinc, make it resistant to viruses and extend its shelf life ten-fold. After more than a decade of research and development, the project would obtain regulatory approval in 2017,* radically improving the health of many millions of people. Although generating controversy, genetic engineering remains a safe and effective method in food, with no cases of illness from over a trillion meals served.*
https://wn.com/Biocassava_Plus_Receives_Regulatory_Approval_In_2017_Brostv
7D Surgical - Regulatory Approval
0:46

7D Surgical - Regulatory Approval

  • Order:
  • Duration: 0:46
  • Updated: 23 Jan 2017
  • views: 4738
videos
7D Surgical has launched an innovative Machine-vision Image Guided Surgery system for spine surgery. This new technology employs cutting-edge 3D optical technologies and machine vision algorithms to eliminate the long-standing barriers to adoption of existing surgical navigational platforms. The 7D Surgical System can easily register spinal surgery patients automatically in an unprecedented entire workflow time of less than 20 seconds, while also eliminating intraoperative radiation. Our navigation technology is embedded in an onboard overhead surgical light, which eliminates line of sight frustrations in the operating room, and along with foot pedal interaction of the software, puts the surgeon in total control. FDA 510(k) clearance and Health Canada approved for the Spinal Application. Please contact 7D Surgical for information on regulatory clearance status of our products in your jurisdiction.
https://wn.com/7D_Surgical_Regulatory_Approval
How Does The FDA Approve New Drugs?
3:29

How Does The FDA Approve New Drugs?

  • Order:
  • Duration: 3:29
  • Updated: 20 Jul 2015
  • views: 78344
videos
Is China Fueling The Drug War? http://testu.be/1GzTYHN Subscribe! http://bitly.com/1iLOHml The Food and Drug Administration is one of the world's strictest regulatory agencies. So, how do drugs get approved for use in the U.S.? Learn More: Drug Safety/Drug Approval Process http://www.fda.gov/NewsEvents/Testimony/ucm161673.htm "Modern drugs provide unmistakable and significant health benefits." House overwhelmingly passes bill to speed FDA drug approvals http://www.washingtonpost.com/blogs/wonkblog/wp/2015/07/10/house-overwhelmingly-passes-bill-to-speed-fda-drug-approvals/ "A bipartisan bill that would make significant changes to the process for developing new drugs and medical devices overwhelmingly passed the House in a 344-77 vote Friday morning." Novel New Drugs 2013 Summary http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DrugInnovation/UCM381803.pdf "In Calendar Year 2013, FDA's Center for Drug Evaluation and Research (CDER) approved 27 novel new medicines, known as new molecular entities (NMEs)." As drug making goes global, oversight found lacking http://www.usatoday.com/story/news/2012/10/21/global-drug-manufacturing-oversight/1646487/ "The medicines you took this morning could have come from anywhere, and everywhere, in the world." Subscribe to TestTube Daily! http://bitly.com/1iLOHml _________________________ TestTube News is committed to answering the smart, inquisitive questions we have about life, society, politics and anything else happening in the news. It's a place where curiosity rules and together we'll get a clearer understanding of this crazy world we live in. Watch more TestTube: http://testtube.com/testtubenews Subscribe now! http://www.youtube.com/subscription_center?add_user=testtubenetwork TestTube on Twitter https://twitter.com/TestTube Trace Dominguez on Twitter https://twitter.com/TraceDominguez TestTube on Facebook https://facebook.com/testtubenetwork TestTube on Google+ http://gplus.to/TestTube Download the New TestTube iOS app! http://testu.be/1ndmmMq Special thanks to Julia Wilde for hosting TestTube! Check Julia on Twitter: https://twitter.com/Julia_SCI
https://wn.com/How_Does_The_Fda_Approve_New_Drugs
Colorants in Devices: Integrated Strategies Toward Regulatory Approval
7:03

Colorants in Devices: Integrated Strategies Toward Regulatory Approval

  • Order:
  • Duration: 7:03
  • Updated: 28 Jul 2015
  • views: 19
videos
Click here to register for free and to view the entire webinar: http://xtalks.com/Colorants-Medical-Devices.ashx?utm_source=YouTube&utm_medium=Teaser&utm_campaign=XTO787_Arazy_Toxikon%20 Speakers: Mark Thomson, MBA, NA Sales & Marketing Manager, Arazy Group Consultants Inc. John Iannone, Program Manager – Extractables/Leachables & Special Studies, Toxikon Corporation A challenge common to all medical device manufacturers, regardless of their products’ level of risk, indications of use, or technical specifications is pre-market approval. An integrated strategy towards regulatory approval is the most critical step for the future of any medical device. Leading regulatory consultancy Arazy Group and one of the world’s premier accredited research and testing facilities, Toxikon Corporation, have established a successful cooperation to aid medical device manufacturers to comply with safety requirements and achieve regulatory approval in global markets. In this webinar Mark Thomson, will talk about effective go-to-market strategies and how medical device registration can be streamlined, simplified, and expedited through Arazy Group’s cloud-based regulatory management system LICENSALE.COM™ in up to 100 countries worldwide. Moving from a broader discussion on regulatory strategies to a specific challenge faced by medical device manufacturers, John Iannone from Toxikon will discuss the regulation of colorants in medical devices and testing strategies to meet requirements for a successful regulatory submission. Key topics: 1. Effective go-to-market strategies and new ways to streamline and expedite global medical device registration 2. Colorants in medical devices: The spectrum of current regulatory expectations Biocompatibility & ISO 10993 Extractables and Leachables / Chemical Characterization of Materials When & How to Pool Samples FDA approved color additives 21 CFR, 73, 74, 81 & 82 Toxicology Risk Assessments
https://wn.com/Colorants_In_Devices_Integrated_Strategies_Toward_Regulatory_Approval
How to obtain regulatory approval of food supplements & novel foods in the EU
12:03

How to obtain regulatory approval of food supplements & novel foods in the EU

  • Order:
  • Duration: 12:03
  • Updated: 23 Oct 2010
  • views: 1329
videos
Dr Wilkinson who has over twenty years experience in the research & development of botanicals and regulatory affairs, outlines the approval steps for novel foods, nutraceuticals, exotic foods and supplements in the EU
https://wn.com/How_To_Obtain_Regulatory_Approval_Of_Food_Supplements_Novel_Foods_In_The_Eu
Covidien's Solitaire™ FR Revascularization Device Receives Regulatory Approval in Brazil
2:06

Covidien's Solitaire™ FR Revascularization Device Receives Regulatory Approval in Brazil

  • Order:
  • Duration: 2:06
  • Updated: 19 Jul 2012
  • views: 7351
videos
Covidien's Solitaire FR device is used to restore blood flow to the brain in patients suffering acute ischemic stroke. http://www.businesswire.com/news/home/20120719005452/en/Covidien%E2%80%99s-Solitaire%E2%84%A2-FR-Revascularization-Device-Receives-Regulatory
https://wn.com/Covidien's_Solitaire™_Fr_Revascularization_Device_Receives_Regulatory_Approval_In_Brazil
FDA Approved: How the FDA Approval Process Works
13:18

FDA Approved: How the FDA Approval Process Works

  • Order:
  • Duration: 13:18
  • Updated: 28 Dec 2012
  • views: 26628
videos
Explains the process that drug makers have to go through to receive approval from the Food and Drug Administration.
https://wn.com/Fda_Approved_How_The_Fda_Approval_Process_Works
Webinar: Regulatory Approval of Aging Infrastructure Programs
1:00:04

Webinar: Regulatory Approval of Aging Infrastructure Programs

  • Order:
  • Duration: 1:00:04
  • Updated: 27 Sep 2016
  • views: 375
videos
Regulatory Approval of Aging Infrastructure Programs Presented by Dr. Richard Brown, Principal Engineer with Exponent and Director of its Engineering Management Consulting September 27, 2016 11:00 a.m. PDT | 2:00 p.m. EDT Learn best practices for gaining regulatory approval of your aging infrastructure programs. Dr. Richard Brown, a leading expert in power distribution reliability and regulatory affairs, will walk you through: Aging infrastructure and rate cases Justifying proactive replacement programs Engaging regulators and commission staff Case Study: Aging Cables About Dr. Brown Dr. Richard E. Brown is the Practice Director for the Engineering Management Consulting practice of Exponent. He has published more than 90 technical articles and is author of the books Electric Power Distribution Reliability and Business Essentials for Utility Engineers. Dr. Brown earned his BSEE, MSEE, and PhD from the University of Washington in Seattle, and his MBA from the University of North Carolina at Chapel Hill. He is a Fellow of the IEEE and a registered Professional Engineer.
https://wn.com/Webinar_Regulatory_Approval_Of_Aging_Infrastructure_Programs
Putting adoptive T cell therapy on the path to regulatory approval
6:01

Putting adoptive T cell therapy on the path to regulatory approval

  • Order:
  • Duration: 6:01
  • Updated: 20 Mar 2015
  • views: 57
videos
Visit http://www.ecancer.org for more. Prof Ribas (UCLA Jonsson Comprehensive Cancer Center, Los Angeles, USA) talks to ecancertv at TAT 2015 about adoptive T-cell therapy approaches and their current stage of clinical development. He also discusses the challenges of moving this personalised approach to cancer therapy into the clinic.
https://wn.com/Putting_Adoptive_T_Cell_Therapy_On_The_Path_To_Regulatory_Approval
Non-Alcoholic Steatohepatitis (NASH) Covance Webinar: Progress Toward Regulatory Approval Pathways
1:01:14

Non-Alcoholic Steatohepatitis (NASH) Covance Webinar: Progress Toward Regulatory Approval Pathways

  • Order:
  • Duration: 1:01:14
  • Updated: 19 Jun 2015
  • views: 997
videos
Learn more about the challenges of this "silent" liver disease along with therapeutic strategies to accelerate both clinical and regulatory efforts for this critical unmet medical need in Non-Alcoholic Steatohepatitis (NASH) studies.
https://wn.com/Non_Alcoholic_Steatohepatitis_(Nash)_Covance_Webinar_Progress_Toward_Regulatory_Approval_Pathways
The FDA Drug Development Process: GLP, GMP and GCP Regulations
1:31:06

The FDA Drug Development Process: GLP, GMP and GCP Regulations

  • Order:
  • Duration: 1:31:06
  • Updated: 24 May 2016
  • views: 15949
videos
This Video provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations. This Video is ideal for those who are new to the Drug Development process and those experienced researchers that need an update on FDA requirements. This webinar will address the basic Drug Development Process, nonclinical trials and human clinical trials. In addition the two major FDA submissions during Drug Development will be covered - the IND submission and the NDA submission. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: support@globalcompliancepanel.com Help us caption & translate this video! http://amara.org/v/JGhy/
https://wn.com/The_Fda_Drug_Development_Process_Glp,_Gmp_And_Gcp_Regulations
Four Cubesats Snuck into Orbit Without Regulatory Approval, FCC Says
7:59

Four Cubesats Snuck into Orbit Without Regulatory Approval, FCC Says

  • Order:
  • Duration: 7:59
  • Updated: 16 Mar 2018
  • views: 83
videos
Four unauthorized cubesats apparently launched atop this Indian Polar Satellite Launch Vehicle rocket in January 2018, according to the U.S.Federal Communications Commission.Concerns about space junk and satellite-launch regulations are swirling after the Federal Communications Commission (FCC) alleged that a U.S.company launched four tiny satellites without permission.As first reported in IEEE Spectrum, four miniature satellites called SpaceBee-1, 2, 3, and 4 launched to orbit from India aboard a Polar Satellite Launch Vehicle (PSLV) rocket in January, along with several dozen other cubesats and an Indian Earth-observing spacecraft.Launch documents did not identify the SpaceBees' operator.But the documents' description of the four satellites matches information that a California-based company called Swarm Technologies filed in an application to the FCC last year.In the application, the company noted plans to launch four satellites on that same rocket and referred to the satellites as "Space BEES."[In Photos: India's PSLV rocket Launches Cartosat-2 Satellite & 30 More!] The FCC declined to comment for IEEE Spectrum's article, and the publication stated that Swarm Technologies did not respond to interview requests.But launch-services provider Spaceflight Industries confirmed to SpaceNews that it integrated the SpaceBees onto the PSLV for Swarm.Spaceflight Industries representatives told SpaceNews that the responsibility for getting the necessary FCC approvals lies with a satellites' developer."I always assumed that people wouldn't launch something if they couldn't" get those approvals, Curt Blake, president of Spaceflight Industries' launch services group, told SpaceNews."I thought that would be sort of a self-regulation function." On March 7, IEEE Spectrum reported, the FCC sent a letter to Swarm Technologies setting aside a grant to expand Swarm's satellite program, pending further review.The reason: "to permit assessment of the impact of the applicant's apparent unauthorized launch and operation of four satellites," according to the letter.Swarm Technologies is operating in stealth mode; its website reveals little information about the company's plans.The one-page site simply states that Swarm will offer "the world's smallest two-way communication satellites." Some more data is available via Swarm's FCC application for the launch.There, the company said the goal of the SpaceBee mission is "a technology demo for two-way communications satellites, data relay and a new attitude-control system."The target altitude was 360 miles (580 kilometers) — roughly 1.5times that of the International Space Station, which orbits at an average height of 250 miles (400 km).But the SpaceBees will sink closer to Earth over time, dragged down by the planet's atmosphere, the application noted.After the satellites' operational phase, they will likely remain in orbit for anywhere from 4.4to nine years, depending on the final orbit of the satellites and the influence o
https://wn.com/Four_Cubesats_Snuck_Into_Orbit_Without_Regulatory_Approval,_Fcc_Says
Accelerating the regulatory approval of autonomous vehicles
26:01

Accelerating the regulatory approval of autonomous vehicles

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  • Duration: 26:01
  • Updated: 19 Dec 2016
  • views: 349
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Presentation by Alex Flamant at Transpolitica 2016. There are currently 3500 auto related deaths a day globally. Smart, connected, autonomous vehicles could significantly reduce that number. That’s a compelling reason to accelerate the regulatory approval of autonomous vehicles. The session was chaired by David Wood and the camera was operated by Kiran Manam. For more information about Notion Capital, see http://www.notioncapital.com/about/. For more information about the event Transpolitica 2016, see https://www.meetup.com/London-Futurists/events/233996384/. For more information about Transpolitica, see https://transpolitica.org/.
https://wn.com/Accelerating_The_Regulatory_Approval_Of_Autonomous_Vehicles
Design for Regulatory Approval as Carefully as You Design Your Automation - Keith Rodwell
26:20

Design for Regulatory Approval as Carefully as You Design Your Automation - Keith Rodwell

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  • Duration: 26:20
  • Updated: 21 Dec 2017
  • views: 244
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Raytheon, a multinational Defense and Cybersecurity industry leader, is on a Digital Transformation journey including expanding its use of compliant Cloud based Service Providers. Embracing Digital Transformation requires cultural shifts, regulatory considerations and new approaches toward driving Regulatory Compliance. This presentation will cover several IT Security and Export/Import compliance challenges companies will likely face as they prepare for regulatory approval for the use of cloud based capabilities. Ensuring you start dialogs with your governing partners, with the right tenor and focus, will support the adoption of durable solutions and configurations, regardless of any particular entity’s needs. This presentation will cover architectural and service owner perspectives on navigating regulatory concerns for Digital Transformation and will include key talking points to ease your discussions with IT Security and Export/Import functions. Slides: https://www.slideshare.net/Pivotal/minimizing-compliance-resistance-to-digital-transformation-design-for-regulatory-approval-as-carefully-as-you-design-your-automation/Pivotal/minimizing-compliance-resistance-to-digital-transformation-design-for-regulatory-approval-as-carefully-as-you-design-your-automation Keith Rodwell, IT Cloud Architect, Raytheon Filmed at SpringOne Platform 2017
https://wn.com/Design_For_Regulatory_Approval_As_Carefully_As_You_Design_Your_Automation_Keith_Rodwell
Kiran Mazumdar-Shaw on Receiving Regulatory Approval for Insulin Glargine in Japan.
3:20

Kiran Mazumdar-Shaw on Receiving Regulatory Approval for Insulin Glargine in Japan.

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  • Duration: 3:20
  • Updated: 29 Mar 2016
  • views: 888
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Kiran Mazumdar- Shaw speaking on Biocon’s landmark achievement of receiving Regulatory Approval for its first Insulin Glargine from PMDA, MHLW in Japan. Proud moment for Biocon, Endorsement of our Capability in Biosimilars and Commitment to Quality. First Biosimilar From India to be approved in Japan. Prefilled Pen to be launched in Q1 FY17.
https://wn.com/Kiran_Mazumdar_Shaw_On_Receiving_Regulatory_Approval_For_Insulin_Glargine_In_Japan.
News Update: AT&T close to regulatory approval for $2.35B deal
0:35

News Update: AT&T close to regulatory approval for $2.35B deal

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  • Duration: 0:35
  • Updated: 17 Jun 2010
  • views: 1987
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AT&T (T) is said to be close to receiving approval from regulators for the proposed $2.35B purchase of rural U.S. wireless licenses from Verizon Wireless, a joint venture between Verizon Communications (VZ) and Vodafone (VOD), the Wall Street Journal reports. People familiar with the matter say that after a prolonged review, a vote in the FCC could happen in coming weeks.
https://wn.com/News_Update_At_T_Close_To_Regulatory_Approval_For_2.35B_Deal
Is regulatory approval of oncology drugs complicated in USA? - Bradford Goodwin
1:10

Is regulatory approval of oncology drugs complicated in USA? - Bradford Goodwin

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  • Duration: 1:10
  • Updated: 14 Aug 2014
  • views: 25
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In USA regulatory approval of drugs is very restrictive. It requires detailed research and investigation: preclinical and clinical as well. It can be 10 or 20 years for an oncology drug to go from a lab to the market. Wprowadzanie na rynek wszystkich leków w USA wymaga przedstawienia wyników wielu szczegółowych badań, także przedklinicznych i klinicznych. Wyprowadzenie preparatu z laboratorium na rynek może zająć nawet 20 lat. Więcej ciekawych publikacji odnajdziesz na portalu biotechnologia.pl ©Biotechnologia.pl/Laborant.pl
https://wn.com/Is_Regulatory_Approval_Of_Oncology_Drugs_Complicated_In_USA_Bradford_Goodwin
BUYING INTO BRITAM: Deal yet to get regulatory approval
1:27

BUYING INTO BRITAM: Deal yet to get regulatory approval

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  • Duration: 1:27
  • Updated: 27 Sep 2017
  • views: 40
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BUYING INTO BRITAM: Deal yet to get regulatory approval SUBSCRIBE to our YouTube channel for more great videos: https://www.youtube.com/ Follow us on Twitter: https://twitter.com/KTNNews Like us on Facebook: https://www.facebook.com/KTNNewsKenya For more great content go to http://www.standardmedia.co.ke/ktnnews and download our apps: http://std.co.ke/apps/#android KTN News is a leading 24-hour TV channel in Eastern Africa with its headquarters located along Mombasa Road, at Standard Group Centre. This is the most authoritative news channel in Kenya and beyond.
https://wn.com/Buying_Into_Britam_Deal_Yet_To_Get_Regulatory_Approval
The regulatory framework in the European Union (EU) for approval of new antibacterials:
17:22

The regulatory framework in the European Union (EU) for approval of new antibacterials:

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  • Duration: 17:22
  • Updated: 04 Dec 2013
  • views: 397
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Speaker: Mair Powell, Infectious Disease Working Party, EMA The regulatory framework in the European Union (EU) for approval of new antibacterials: underlying principles, available options, impact on development of new, effective antibacterials and considerations to have rapid authorisations Session 1: Approval of new antibacterials Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem
https://wn.com/The_Regulatory_Framework_In_The_European_Union_(Eu)_For_Approval_Of_New_Antibacterials
BitFlyer Receives Regulatory Approval to Operate in the European Union
4:40

BitFlyer Receives Regulatory Approval to Operate in the European Union

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  • Duration: 4:40
  • Updated: 25 Jan 2018
  • views: 5
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BitFlyer Receives Regulatory Approval to Operate in the European Union Europe has always been a relatively tepid market when it comes to Bitcoin and other cryptocurrencies. It almost seems as if there is a genuine disinterest in what this new form of money can mean for E... ************************************* Thank fof watching. Don't forget subscriber my channel.
https://wn.com/Bitflyer_Receives_Regulatory_Approval_To_Operate_In_The_European_Union
PSTI Cell Manufacturing Facility Receives German Regulatory Approval of 3D Manufacturing Process
1:36

PSTI Cell Manufacturing Facility Receives German Regulatory Approval of 3D Manufacturing Process

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  • Duration: 1:36
  • Updated: 24 Jan 2014
  • views: 228
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HAIFA, Israel, Jan. 23, 2014 (GLOBE NEWSWIRE) -- Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell product candidates, today announced it has received approval from the Paul-Ehrlich-Institute (PEI), Germany's health authority, to supply cells from its advanced, fully automated, and proprietary 3D cell expansion manufacturing platform implemented at its new state-of-the-art GMP facility. Pluristem's new manufacturing facility has the capability to efficiently produce over 150,000 doses of PLX cells annually, which potentially translates into significant economic value. This marks the first regulatory approval of Pluristem's new facility where the company has implemented its large scale 3D bioreactor expansion of placental-derived mesenchymal-like Adherent Stromal Cells (ASCs). The approval will enable the company to easily support ongoing trials and enter into multiple clinical trials using its scale-up capabilities for cell supply. The company is also in the process of getting approvals from other regulatory authorities including the US FDA. "We are very pleased to receive the PEI's approval. Following our multi-million dollar investment into the development of our proprietary high-throughput culturing technologies, 3D bioreactors, and proprietary downstream equipment, the PEI's approval confirms Pluristem's unique position in the cell therapy industry. Our proprietary 3D manufacturing process can create commercial quantities of cells with batch-to-batch consistency, so we are ready to expand and accelerate our clinical programs," stated Zami Aberman, Chairman and CEO of Pluristem. "In addition, the very encouraging results of our Phase I/II trial in muscle injury conducted in Germany suggest that our unique culturing technology may contribute to the quality and consistency of PLX clinical studies." About Pluristem's 3D Manufacturing Pluristem's state-of-the-art manufacturing site is located in MATAM industrial park, in Haifa, Israel and is equipped with 500 square meters of clean rooms in which cells can be manufactured to support clinical trials and for commercial demand at time of regulatory approval. Pluristem develops and manufactures its products in full compliance with international quality standards, including U.S. Food and Drug Administration (FDA), European Medicines Agencies (EMA), current Good Manufacturing Practices (cGMP) requirements and International Conference on Harmonization (ICH) quality guidelines. Pluristem believes that controlling the process is the key to success and therefore invests major efforts in developing highly efficient, cutting-edge culturing systems enabling advancement of its large PLX cell therapy product candidate's pipeline. About Pluristem Therapeutics Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapies. The Company's patented PLX (PLacental eXpanded) cells are a drug delivery platform that releases a cocktail of therapeutic proteins in response to a host of local and systemic inflammatory and ischemic diseases. PLX cells are grown using the company's proprietary 3D micro-environmental technology and are an "off-the-shelf" product that requires no tissue matching prior to administration. Pluristem has a strong intellectual property position, company-owned GMP certified manufacturing and research facilities, strategic relationships with major research institutions and a seasoned management team. For more information visit www.pluristem.com, the content of which is not part of this press release.
https://wn.com/Psti_Cell_Manufacturing_Facility_Receives_German_Regulatory_Approval_Of_3D_Manufacturing_Process
St. Jude Medical Announces European Regulatory Approval of Implanted Neurostimulation Device
0:20

St. Jude Medical Announces European Regulatory Approval of Implanted Neurostimulation Device

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  • Duration: 0:20
  • Updated: 07 Sep 2011
  • views: 2233
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The St. Jude Medical Genesis(TM) neurostimulation system is the only fully implantable neurostimulation system that is approved in Europe for peripheral nerve stimulation (PNS) of the occipital nerves for the management of the pain and disability for patients diagnosed with intractable chronic migraine. PNS for intractable chronic migraine involves the delivery of mild electrical pulses to the occipital nerves that are located just beneath the skin at the back of the head. A small electrical lead or leads are placed under the skin and connected to the Genesis neurostimulator, a pacemaker-like device, which produces the pulses of stimulation. Animation provided by St. Jude Medical, Inc. (Business Wire) Business Wire Press Release available: http://www.businesswire.com/news/home/20110906007202/en/St.-Jude-Medical-Announces-European-Regulatory-Approval
https://wn.com/St._Jude_Medical_Announces_European_Regulatory_Approval_Of_Implanted_Neurostimulation_Device
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