- published: 30 Jul 2015
- views: 8590
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
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
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...
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/.
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...
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...
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
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, ...
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
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.
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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.
#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.
Sunwin International corporate website: http://sunwininternational.com/ Link to original press release: http://finance.yahoo.com/news/Sunwin-International-prnews-563757709.html?x=0&l=1 Sunwin International Neutraceuticals, Inc., is hereby providing cautionary statements identifying important factors that could cause our actual results to differ materially from those projected in forward-looking statements (as defined in such act). Any statements that are not historical facts and that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, indicated through the use of words or phrases such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "inte...
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.
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...
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
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: firstname.lastname@example.org Help us caption & translate this vid...
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.
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
(Part 1 of 3) General overview of medical device regulation.
http://ntvuganda.co.ug/ The World's fourth largest mobile phone operator, Bharti Airtel has signed an agreement to buy rival Warid Telecom Uganda. The deal with Uganda's No.3 mobile phone company adds 2.8 million customers to its total user base to 7.4 million.
Course Description: Manufacturers planning to market their devices in Europe are required to furnish clinical data in line with the European Directives. This course provides professionals with an expert overview of the EU regulations and how they can positively impact global market access as well as a detailed outline of the necessary steps to follow to achieve immediate and lasting compliance of their clinical evaluation.