• 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
  • Howard Bancorp Given Regulatory Approval To Acquire First Mariner Bank

    Howard Bancorp has been given approval to acquire First Mariner Bank, the Federal Reserve Board announced Monday.

    published: 13 Feb 2018
  • 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
  • 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
  • WEBINAR: Content Uniformity by Transmission Raman – Gaining Regulatory Approval

    Cobalt's December 2014 video looked at the regulatory aspects of transmission Raman submissions as an alternative to content uniformity and bulk assay by HPLC. Cobalt's Transmission Raman experts were joined by experts in the field of pharma regulatory submission, Dr Phil Doherty of Process Analytics Ltd, and Dr Gemma Robinson of Acorn Regulatory

    published: 15 Dec 2015
  • Biosimilar Generic Biologics In The USA Approval Pathway

    This video presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The video also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss. 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/JGYo/

    published: 24 May 2016
  • 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
  • Need of regulatory approval to set up an Indian company.

    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
  • 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
  • Stocks E Trading Operators Confirm Regulatory Approval

    For more information log on to www.channelstv.com.

    published: 21 Jul 2014
  • 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
  • Webinar on Regulatory and Procedural Aspects of Type I variations

    15 November 2016 Webinar on Regulatory and Procedural Aspects of Type I variations Procedure Managers in Human Medicines Evaluation Division, EMA

    published: 13 Dec 2016
  • 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
  • TFKable announces new CEO, regulatory approval for JDR acquisition

    #oilwire - Group TELE-FONIKA Kable, a global producer of wires and cables, today announces that regulatory approval for its acquisition of JDR Cable Systems Ltd., a supplier of subsea umbilicals and power cables to the offshore energy industry, has been granted. The completion, which is expected within a week pending final legal and administrative proceedings, comes as JDR introduces its new CEO, Richard Turner. Richard joined JDR as chief operating officer in 2014 to lead the global manufacturing, project management and supply chain functions. He came with a background of senior management positions at Komatsu, Terex and Technip and holds mechanical engineering and MBA degrees.

    published: 25 Aug 2017
  • 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
  • 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
  • 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
  • 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
  • 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
  • Trends in Supplier Control and Regulatory Approval - Dr. Chris Devine

    Interview with Dr.Chris Devine at Medical Device Summit's Supplier Controls Conference discusses challenges in supplier controls and virtual medical device companies. Large or small the FDA holds you responsible for regulatory issues and effective design and manufacturing process validation.

    published: 01 Jun 2012
  • 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
  • VA Approval and Regulatory Process Carol Wampler Part 1

    published: 23 Jun 2011
  • Does the industry need to rethink its approach to regulatory approval in light of low approval rates

    World Vaccine Congress & Expo 2013 We asked attendees at the World Vaccine Congress: does the industry need to rethink its approach to vaccine regulatory approval in light of low approval rates? The World Vaccine Congress & Expo is now in its 13th year and is the biggest and most comprehensive event for the industry. Covering everything from the latest R&D to manufacturing to the corporate development strategies you'll be sure to find answers to all your questions. Visit our Website: http://www.terrapinn.com/2013/world-vaccine-congress-washington/index.stm Read our blog: http://blogs.terrapinn.com/vaccinenation/ Follow us on Twitter: @vaccinenation Join our Linkedin group: http://www.linkedin.com/groups/Vaccine-Nation-1351197

    published: 26 Apr 2013
  • 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
developed with YouTube
7D Surgical - Regulatory Approval

7D Surgical - Regulatory Approval

  • Order:
  • Duration: 0:46
  • Updated: 23 Jan 2017
  • views: 4392
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
Howard Bancorp Given Regulatory Approval To Acquire First Mariner Bank

Howard Bancorp Given Regulatory Approval To Acquire First Mariner Bank

  • Order:
  • Duration: 0:29
  • Updated: 13 Feb 2018
  • views: 5
videos
Howard Bancorp has been given approval to acquire First Mariner Bank, the Federal Reserve Board announced Monday.
https://wn.com/Howard_Bancorp_Given_Regulatory_Approval_To_Acquire_First_Mariner_Bank
Design for Regulatory Approval as Carefully as You Design Your Automation - Keith Rodwell

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

  • Order:
  • Duration: 26:20
  • Updated: 21 Dec 2017
  • views: 193
videos
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
Accelerating the regulatory approval of autonomous vehicles

Accelerating the regulatory approval of autonomous vehicles

  • Order:
  • Duration: 26:01
  • Updated: 19 Dec 2016
  • views: 344
videos
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
WEBINAR: Content Uniformity by Transmission Raman – Gaining Regulatory Approval

WEBINAR: Content Uniformity by Transmission Raman – Gaining Regulatory Approval

  • Order:
  • Duration: 1:26:24
  • Updated: 15 Dec 2015
  • views: 148
videos
Cobalt's December 2014 video looked at the regulatory aspects of transmission Raman submissions as an alternative to content uniformity and bulk assay by HPLC. Cobalt's Transmission Raman experts were joined by experts in the field of pharma regulatory submission, Dr Phil Doherty of Process Analytics Ltd, and Dr Gemma Robinson of Acorn Regulatory
https://wn.com/Webinar_Content_Uniformity_By_Transmission_Raman_–_Gaining_Regulatory_Approval
Biosimilar Generic Biologics In The USA Approval Pathway

Biosimilar Generic Biologics In The USA Approval Pathway

  • Order:
  • Duration: 1:32:09
  • Updated: 24 May 2016
  • views: 420
videos
This video presents an overview of FDA's requirements for approval/marketing of a Biosimilar (Generic Biologic) product. The webinar covers the Biosimilar product testing requirements (clinical and nonclinical) and the Biosimilar approval pathway. The video also reviews the Regulatory/Scientific/Quality principles involved along with the 3 FDA Biosimilar guideline documents. In addition, the FDA Stepwise Approach and the FDA Totality of the Evidence concepts will be discuss. 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/JGYo/
https://wn.com/Biosimilar_Generic_Biologics_In_The_USA_Approval_Pathway
BIOCASSAVA PLUS RECEIVES REGULATORY APPROVAL IN 2017 -BrosTV

BIOCASSAVA PLUS RECEIVES REGULATORY APPROVAL IN 2017 -BrosTV

  • Order:
  • Duration: 2:16
  • Updated: 08 Mar 2017
  • views: 65
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
Need of regulatory approval to set up an Indian company.

Need of regulatory approval to set up an Indian company.

  • Order:
  • Duration: 3:48
  • Updated: 19 Jun 2012
  • views: 43
videos
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.
How Does The FDA Approve New Drugs?

How Does The FDA Approve New Drugs?

  • Order:
  • Duration: 3:29
  • Updated: 20 Jul 2015
  • views: 76359
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
Stocks E Trading Operators Confirm Regulatory Approval

Stocks E Trading Operators Confirm Regulatory Approval

  • Order:
  • Duration: 2:25
  • Updated: 21 Jul 2014
  • views: 31
videos
For more information log on to www.channelstv.com.
https://wn.com/Stocks_E_Trading_Operators_Confirm_Regulatory_Approval
Kiran Mazumdar-Shaw on Receiving Regulatory Approval for Insulin Glargine in Japan.

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

  • Order:
  • Duration: 3:20
  • Updated: 29 Mar 2016
  • views: 855
videos
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.
Webinar on Regulatory and Procedural Aspects of Type I variations

Webinar on Regulatory and Procedural Aspects of Type I variations

  • Order:
  • Duration: 1:52:45
  • Updated: 13 Dec 2016
  • views: 1538
videos
15 November 2016 Webinar on Regulatory and Procedural Aspects of Type I variations Procedure Managers in Human Medicines Evaluation Division, EMA
https://wn.com/Webinar_On_Regulatory_And_Procedural_Aspects_Of_Type_I_Variations
Colorants in Devices: Integrated Strategies Toward Regulatory Approval

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
TFKable announces new CEO, regulatory approval for JDR acquisition

TFKable announces new CEO, regulatory approval for JDR acquisition

  • Order:
  • Duration: 3:08
  • Updated: 25 Aug 2017
  • views: 18
videos
#oilwire - Group TELE-FONIKA Kable, a global producer of wires and cables, today announces that regulatory approval for its acquisition of JDR Cable Systems Ltd., a supplier of subsea umbilicals and power cables to the offshore energy industry, has been granted. The completion, which is expected within a week pending final legal and administrative proceedings, comes as JDR introduces its new CEO, Richard Turner. Richard joined JDR as chief operating officer in 2014 to lead the global manufacturing, project management and supply chain functions. He came with a background of senior management positions at Komatsu, Terex and Technip and holds mechanical engineering and MBA degrees.
https://wn.com/Tfkable_Announces_New_Ceo,_Regulatory_Approval_For_Jdr_Acquisition
The FDA Drug Development Process: GLP, GMP and GCP Regulations

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

  • Order:
  • Duration: 1:31:06
  • Updated: 24 May 2016
  • views: 13049
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
News Update: AT&T close to regulatory approval for $2.35B deal

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

  • Order:
  • Duration: 0:35
  • Updated: 17 Jun 2010
  • views: 1987
videos
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
How to obtain regulatory approval of food supplements & novel foods in the EU

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

  • Order:
  • Duration: 12:03
  • Updated: 23 Oct 2010
  • views: 1319
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
FDA Approved: How the FDA Approval Process Works

FDA Approved: How the FDA Approval Process Works

  • Order:
  • Duration: 13:18
  • Updated: 28 Dec 2012
  • views: 25683
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
Covidien's Solitaire™ FR Revascularization Device Receives Regulatory Approval in Brazil

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

  • Order:
  • Duration: 2:06
  • Updated: 19 Jul 2012
  • views: 7201
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
Trends in Supplier Control and Regulatory Approval - Dr. Chris Devine

Trends in Supplier Control and Regulatory Approval - Dr. Chris Devine

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  • Duration: 7:23
  • Updated: 01 Jun 2012
  • views: 289
videos
Interview with Dr.Chris Devine at Medical Device Summit's Supplier Controls Conference discusses challenges in supplier controls and virtual medical device companies. Large or small the FDA holds you responsible for regulatory issues and effective design and manufacturing process validation.
https://wn.com/Trends_In_Supplier_Control_And_Regulatory_Approval_Dr._Chris_Devine
Non-Alcoholic Steatohepatitis (NASH) Covance Webinar: Progress Toward Regulatory Approval Pathways

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

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  • Duration: 1:01:14
  • Updated: 19 Jun 2015
  • views: 962
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
VA Approval and Regulatory Process   Carol Wampler Part 1

VA Approval and Regulatory Process Carol Wampler Part 1

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  • Duration: 13:06
  • Updated: 23 Jun 2011
  • views: 82
videos
https://wn.com/Va_Approval_And_Regulatory_Process_Carol_Wampler_Part_1
Does the industry need to rethink its approach to regulatory approval in light of low approval rates

Does the industry need to rethink its approach to regulatory approval in light of low approval rates

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  • Duration: 2:36
  • Updated: 26 Apr 2013
  • views: 80
videos
World Vaccine Congress & Expo 2013 We asked attendees at the World Vaccine Congress: does the industry need to rethink its approach to vaccine regulatory approval in light of low approval rates? The World Vaccine Congress & Expo is now in its 13th year and is the biggest and most comprehensive event for the industry. Covering everything from the latest R&D to manufacturing to the corporate development strategies you'll be sure to find answers to all your questions. Visit our Website: http://www.terrapinn.com/2013/world-vaccine-congress-washington/index.stm Read our blog: http://blogs.terrapinn.com/vaccinenation/ Follow us on Twitter: @vaccinenation Join our Linkedin group: http://www.linkedin.com/groups/Vaccine-Nation-1351197
https://wn.com/Does_The_Industry_Need_To_Rethink_Its_Approach_To_Regulatory_Approval_In_Light_Of_Low_Approval_Rates
Webinar: Regulatory Approval of Aging Infrastructure Programs

Webinar: Regulatory Approval of Aging Infrastructure Programs

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  • Duration: 1:00:04
  • Updated: 27 Sep 2016
  • views: 372
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