• 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Need of regulatory approval to set up an Indian company.

    published: 19 Jun 2012
  • FDA Regulation of Medical Devices (Part 1 of 3)

    (Part 1 of 3) General overview of medical device regulation.

    published: 28 Feb 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
  • 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
  • Drug Regulatory Affairs in a Pharmaceutical Company

    Drug Regulatory Affairs job profile in a pharmaceutical company.

    published: 20 Mar 2016
  • PAC-MAN WILD EDITION™ To AUSTRALIA (Subject to regulatory approval)

    Coming soon to Australian gaming floors! The iconic PAC-MAN character is one of the most recognisable figures in arcade game history and was the basis for the most successful arcade game of all time. Now, Ainsworth has transformed this game into a standalone progressive title and will soon release the PAC-MAN WILD EDITION™ in the A640® cabinet.

    published: 04 Aug 2017
  • 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
  • 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
  • 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
  • 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
  • Family bank secures regulatory approval to raise 10 billion shillings

    Mid-tier lender, family bank has secured regulatory approval to raise 10 billion shillings through a multi-currency medium-term note. The approval paves the way for the bank to raise additional capital to support its strategic growth plans in its quest to break into tier one banks. Watch KTN Live http://www.ktnkenya.tv/live Watch KTN News http://www.ktnnews.com Follow us on http://www.twitter.com/ktnkenya Like us on http://www.facebook.com/ktnkenya

    published: 23 Sep 2015
  • 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
  • Stocks E Trading Operators Confirm Regulatory Approval

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

    published: 21 Jul 2014
  • 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 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
  • 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
  • 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
  • Success Factors in Your IND Filing

    The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even expe...

    published: 15 Feb 2016
  • How to Obtain regulatory approval of food supplements and novel foods in the EU

    published: 07 Oct 2016
  • Need of regulatory approval to set up an Indian company.

    published: 19 Jun 2012
  • [CUBESAT2017] Australian Regulatory Approvals for the QB50 Project

    19th April 2017, UNSW Sydney Thai Loi, Helen Brown and Elias Aboutanios UNSW Legal Australian Regulatory Approvals for the QB50 Project

    published: 02 May 2017
  • Section 6 - Applicant Current and Previous Regulatory Approvals

    Section 6 - Applicant Current and Previous Regulatory Approvals - in relation to completing and submitting an Individual Questionnaire through the Central Bank of Ireland's Online Reporting System

    published: 27 Feb 2017
  • Open rack enhancements for regulatory approvals and support for telco use cases

    In order to deploy commercially OCP Open Rack, mandatory regulatory approvals needed (FCC, CE, KCCI..)

    published: 10 Mar 2016
7D Surgical - Regulatory Approval

7D Surgical - Regulatory Approval

  • Order:
  • Duration: 0:46
  • Updated: 23 Jan 2017
  • views: 3387
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
Accelerating the regulatory approval of autonomous vehicles

Accelerating the regulatory approval of autonomous vehicles

  • Order:
  • Duration: 26:01
  • Updated: 19 Dec 2016
  • views: 313
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
A guide to new medicines approval

A guide to new medicines approval

  • Order:
  • Duration: 2:20
  • Updated: 30 Jul 2015
  • views: 7599
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
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: 16
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
Is regulatory approval of oncology drugs complicated in USA? - Bradford Goodwin

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

  • Order:
  • Duration: 1:10
  • Updated: 14 Aug 2014
  • views: 24
videos
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
Webinar: Regulatory Approval of Aging Infrastructure Programs

Webinar: Regulatory Approval of Aging Infrastructure Programs

  • Order:
  • Duration: 1:00:04
  • Updated: 27 Sep 2016
  • views: 334
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
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: 42
videos
https://wn.com/Need_Of_Regulatory_Approval_To_Set_Up_An_Indian_Company.
FDA Regulation of Medical Devices (Part 1 of 3)

FDA Regulation of Medical Devices (Part 1 of 3)

  • Order:
  • Duration: 16:48
  • Updated: 28 Feb 2015
  • views: 12143
videos
(Part 1 of 3) General overview of medical device regulation.
https://wn.com/Fda_Regulation_Of_Medical_Devices_(Part_1_Of_3)
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: 3
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
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: 30
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
Drug Regulatory Affairs in a Pharmaceutical Company

Drug Regulatory Affairs in a Pharmaceutical Company

  • Order:
  • Duration: 1:36
  • Updated: 20 Mar 2016
  • views: 4133
videos
Drug Regulatory Affairs job profile in a pharmaceutical company.
https://wn.com/Drug_Regulatory_Affairs_In_A_Pharmaceutical_Company
PAC-MAN WILD EDITION™ To AUSTRALIA (Subject to regulatory approval)

PAC-MAN WILD EDITION™ To AUSTRALIA (Subject to regulatory approval)

  • Order:
  • Duration: 1:11
  • Updated: 04 Aug 2017
  • views: 356
videos
Coming soon to Australian gaming floors! The iconic PAC-MAN character is one of the most recognisable figures in arcade game history and was the basis for the most successful arcade game of all time. Now, Ainsworth has transformed this game into a standalone progressive title and will soon release the PAC-MAN WILD EDITION™ in the A640® cabinet.
https://wn.com/Pac_Man_Wild_Edition™_To_Australia_(Subject_To_Regulatory_Approval)
Trends in Supplier Control and Regulatory Approval - Dr. Chris Devine

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

  • Order:
  • Duration: 7:23
  • Updated: 01 Jun 2012
  • views: 286
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
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: 1275
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
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

  • Order:
  • Duration: 2:36
  • Updated: 26 Apr 2013
  • views: 79
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
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: 6740
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
Family bank secures regulatory approval to raise 10 billion shillings

Family bank secures regulatory approval to raise 10 billion shillings

  • Order:
  • Duration: 1:12
  • Updated: 23 Sep 2015
  • views: 58
videos
Mid-tier lender, family bank has secured regulatory approval to raise 10 billion shillings through a multi-currency medium-term note. The approval paves the way for the bank to raise additional capital to support its strategic growth plans in its quest to break into tier one banks. Watch KTN Live http://www.ktnkenya.tv/live Watch KTN News http://www.ktnnews.com Follow us on http://www.twitter.com/ktnkenya Like us on http://www.facebook.com/ktnkenya
https://wn.com/Family_Bank_Secures_Regulatory_Approval_To_Raise_10_Billion_Shillings
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: 768
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.
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
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: 1986
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 Does The FDA Approve New Drugs?

How Does The FDA Approve New Drugs?

  • Order:
  • Duration: 3:29
  • Updated: 20 Jul 2015
  • views: 72166
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
St. Jude Medical Announces European Regulatory Approval of Implanted Neurostimulation Device

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

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  • Duration: 0:20
  • Updated: 07 Sep 2011
  • views: 2201
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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
PSTI Cell Manufacturing Facility Receives German Regulatory Approval of 3D Manufacturing Process

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

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  • Duration: 1:36
  • Updated: 24 Jan 2014
  • views: 214
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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
Success Factors in Your IND Filing

Success Factors in Your IND Filing

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  • Duration: 1:01:47
  • Updated: 15 Feb 2016
  • views: 2002
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The successful filing of an Investigational New Drug application (IND) is a pivotal milestone for an emerging pharma company. This webinar is designed to address this crucial topic for the key industry segment. Citing the FDA website for an Investigational New Drug Application, “Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” This webinar is geared towards smaller pharma companies filing an IND for the first time but even experienced drug developers could benefit from an overview of the requirements and considerations. The goal of the webinar is to educate and enable our listeners in pursuit of this key objective. While this particular talk is geared towards small molecule active pharmaceutical ingredients (API) and drug products, much of it applies to biologic products as well. The Webinar features three prominent experts in the pharmaceutical development arena and each will highlight a different facet of the IND process. Jennifer Stanek has over 20 years of experience with key roles in CMC regulatory affairs, formulation development and analytical development. She has expertise in the coordination, preparation and management of global clinical trial applications, new marketing registrations, drug master file applications and their life-cycle management. Ms. Stanek began her career at G.D. Searle, moved into CMC consulting and is currently with Takeda where she serves as Director in Global Regulatory Affairs CMC. Jennifer will be providing an overview of the US IND format including an explanation of Modules 1-5, CMC (Chemistry, Manufacturing & Controls) submission timings, FDA meetings (timing, preparation, etc), and other CMC considerations. Dan Weissmueller is the Director of Quality at Regis Technologies. Dan’s experience and expertise include analytical development, process and analytical validation, IND support to Regis’ custom API customers, Drug Master File (DMF) regulatory approvals worldwide and FDA inspections. Dan has been with Regis for about 15 years where he has worked with numerous early phase API developments candidates and been the responsible person for the fillings of 3 approved drugs in over 20 countries. Dan is in the process of completing his Masters’ in Quality and Regulatory Sciences from Northwestern University. Working from the perspective of a custom manufacturing organization (CMO) quality assurance director, Dan has seen both the good and bad in terms of a customer’s preparation for an IND filing. Dan will be highlighting aspects of drug substance development and cGMP scale up as it applies to the IND requirements for small molecule API’s. Topics include the development lifecycle, validation considerations, equipment qualification and risk management. Steve Pondell brings over 30 years of experience in manufacturing and serves as Vice President of CMC at ESSA Pharmaceuticals and previously as a Principal at Integrated Biotech Solutions in Houston, Texas. Steve is a CMC expert in the manufacturing, compliance and regulatory aspects of product development from clinical manufacturing, through global regulatory approvals and into commercial production. Steve has served a variety of small to medium sized pharma and biotech companies with projects that include GMP Gap Analysis, Phase I product development programs, and cGMP compliance. Steve will focus his talk on the IND requirements for Drug Product along with the corresponding analytical considerations. Topics include container/closure, dosage form (e.g. oral, injectable, etc), analytical method requirements, specifications, validation requirements and product stability.
https://wn.com/Success_Factors_In_Your_Ind_Filing
How to Obtain regulatory approval of food supplements and novel foods in the EU

How to Obtain regulatory approval of food supplements and novel foods in the EU

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  • Duration: 12:03
  • Updated: 07 Oct 2016
  • views: 2
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https://wn.com/How_To_Obtain_Regulatory_Approval_Of_Food_Supplements_And_Novel_Foods_In_The_Eu
Need of regulatory approval to set up an Indian company.

Need of regulatory approval to set up an Indian company.

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  • Duration: 3:48
  • Updated: 19 Jun 2012
  • views: 42
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https://wn.com/Need_Of_Regulatory_Approval_To_Set_Up_An_Indian_Company.
[CUBESAT2017] Australian Regulatory Approvals for the QB50 Project

[CUBESAT2017] Australian Regulatory Approvals for the QB50 Project

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  • Duration: 14:29
  • Updated: 02 May 2017
  • views: 7
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19th April 2017, UNSW Sydney Thai Loi, Helen Brown and Elias Aboutanios UNSW Legal Australian Regulatory Approvals for the QB50 Project
https://wn.com/Cubesat2017_Australian_Regulatory_Approvals_For_The_Qb50_Project
Section 6 - Applicant Current and Previous Regulatory Approvals

Section 6 - Applicant Current and Previous Regulatory Approvals

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  • Duration: 3:49
  • Updated: 27 Feb 2017
  • views: 6
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Section 6 - Applicant Current and Previous Regulatory Approvals - in relation to completing and submitting an Individual Questionnaire through the Central Bank of Ireland's Online Reporting System
https://wn.com/Section_6_Applicant_Current_And_Previous_Regulatory_Approvals
Open rack enhancements for regulatory approvals and support for telco use cases

Open rack enhancements for regulatory approvals and support for telco use cases

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  • Duration: 23:21
  • Updated: 10 Mar 2016
  • views: 118
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In order to deploy commercially OCP Open Rack, mandatory regulatory approvals needed (FCC, CE, KCCI..)
https://wn.com/Open_Rack_Enhancements_For_Regulatory_Approvals_And_Support_For_Telco_Use_Cases