|By PR Newswire||
|September 4, 2014 07:29 PM EDT||
The statement below was released today by the International Coalition of Medicines Regulatory Authorities (ICMRA) interim Management Committee following a recent international meeting in Rio. In addition to Health Canada, members include the Therapeutic Goods Administration, Australia; National Health Surveillance, Brazil; China Food and Drug Administration, China; European Medicines Agency; European Commission - Directorate General for Health and Consumers; Health Product Regulatory Authority, Ireland; Italian Medicines Agency, Italy; Ministry of Health, Labour and Welfare, and the Pharmaceuticals and Medical Devices Agency, Japan; Medicines Evaluation Board, Netherlands; Health Sciences Authority, Singapore; Medicines Control Council, South Africa; Medicines and Healthcare Products Regulatory Agency, United Kingdom; Food and Drug Administration, United States.
Medicines regulators to work together internationally to find innovative solutions to facilitate evaluation of and access to potential new medicines to counter Ebola outbreaks
OTTAWA, Sept. 4, 2014 /CNW/ - The largest, most severe and most complex outbreak of Ebola virus disease in history is highlighting the absence of authorised medicines to treat or prevent this terrible disease affecting people in a number of countries in West Africa.
In the face of this outbreak, medicines regulators worldwide have committed to enhanced cooperation with the World Health Organization (WHO) and between regulatory agencies to encourage submission of regulatory dossiers and evaluation of the submitted information on potential new medicines. The aim is to accelerate access to investigational treatments for patients most in need during the current outbreak. The enhanced cooperation also aims to ensure that in the future, public health authorities in countries affected by Ebola have safe and efficacious medicines at their disposal, and so strengthen their ability to respond effectively to outbreaks and to save lives.
This pledge was made by members of an interim International Coalition of Medicines Regulatory Authorities (ICMRA) in the margins of the 16th WHO International Conference of Drug Regulatory Authorities (ICDRA) held in Rio de Janeiro from 24-29 August 2014.
Over the past decade, research has been carried out into medicines and vaccines to protect against or to combat Ebola. Some of the investigational medicines or vaccines studied have shown encouraging results in the laboratory and in animal models. However, they have not yet been evaluated for safety and efficacy in humans for the treatment or prevention of Ebola virus disease and may pose risks that have not yet been identified. In addition, these products may be ineffective and it is even possible that some of these investigational medicines might worsen the ultimate outcome of Ebola virus disease.
The role of medicines regulators is to evaluate the detailed evidence generated in clinical studies and to determine that the benefit risk balance of using those medicines is positive for patients in need of prevention or treatment of disease. The countries most affected by the current outbreak of Ebola virus disease often do not have reliable systems for routine data collection. In the current crisis, it is a great challenge to come up with practical solutions to ensure that meaningful data is collected and assessed so that decisions on the benefits and risks of medicines can be taken on the basis of limited scientific evidence, avoiding undue risks to patients.
Regulatory agencies therefore have pledged at their Rio de Janeiro meeting to join their expertise to consider evidence from a wide range of sources to allow for decision-making under a greater degree of scientific uncertainty.
Although the development of medicines against Ebola is ongoing, the majority of patients affected by the virus do not have access to these treatments. Regulators therefore also stress that the search for pharmaceutical interventions must not detract from the need to strengthen basic healthcare measures such as fluids and electrolytes management and to carefully observe the impact and contribution of these measures in the overall response to the disease.
It is important to note that the most effective way to combat the current Ebola outbreak is through basic public health measures, such as good infection control, isolation, contact tracing, and use of personal protective equipment.
These issues will be discussed at a WHO CONSULTATION on potential Ebola therapies and vaccines on 4-5 September in Geneva with regulatory experts from leading agencies worldwide expected to play a key role.
Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media
SOURCE Health Canada
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 27, 2016 08:45 PM EDT Reads: 1,756
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 27, 2016 08:45 PM EDT Reads: 2,290
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Aug. 27, 2016 06:15 PM EDT Reads: 712
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Aug. 27, 2016 06:00 PM EDT Reads: 3,083
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
Aug. 27, 2016 06:00 PM EDT Reads: 723
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 27, 2016 05:15 PM EDT Reads: 1,571
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 27, 2016 05:00 PM EDT Reads: 1,876
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 27, 2016 04:45 PM EDT Reads: 1,626
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 27, 2016 04:00 PM EDT Reads: 570
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 27, 2016 03:15 PM EDT Reads: 760
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 27, 2016 02:45 PM EDT Reads: 3,446
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Aug. 27, 2016 12:45 PM EDT Reads: 2,343
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 27, 2016 12:30 PM EDT Reads: 3,616
SYS-CON Events announced today that eCube Systems, a leading provider of middleware modernization, integration, and management solutions, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. eCube Systems offers a family of middleware evolution products and services that maximize return on technology investment by leveraging existing technical equity to meet evolving business needs. ...
Aug. 27, 2016 12:00 PM EDT Reads: 640
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 27, 2016 12:00 PM EDT Reads: 661