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![]() ![]() The EU ct regulation introduces a new procedure, new timelines, and revised application content. Investigational medicinal product dossier/ĮU Paediatric Investigation Plan decision Suitability of investigators and facilities Justification for the classification as a low intervention Table A: New CT application summary Part I Table B provides a summary of the CT application procedural timelines. The portal will determine when the milestones such as the validation date have been met. If a sponsor fails to reply to a request for information by the deadline, this will lead to the automatic (tacit) withdrawal of the application in all CMSs. If the RMS does not provide validation feedback within the defined time frame, for example, this will be considered a tacit validation of the application. The regulation requires strict adherence to the maximum timelines for each phase of the application procedure and has provisions to ensure that delays from any party do not hold up the process. The validation date is the date the RMS notifies the sponsor of the end of validation, or the natural end of the 10 or 10 + 15 days, whichever comes first. A 15-day extension can be allocated if needed to resolve issues this provides an additional 10 days for the sponsor to respond/update the application and 5 days for member state confirmation, based on the information provided. Member state requests for information during validation should be sent within 10 days of the submission. During this period the member states may request additional information from the sponsor. Validationįollowing submission, there is a validation period to assess whether the application is complete and whether the application is in scope of the regulation. The sponsor’s RMS proposal may not always be accommodated, and in these cases the member state that has either self-nominated or been selected will instead be the RMS. At the time of application, the sponsor proposes a reporting member state (RMS), who will be confirmed by day 6 following submission. The application is submitted via the portal to all concerned member states (CMSs) in which the sponsor intends to conduct the CT (Figure 1). We will learn more as development of the portal and database progress, but we do know that there will be provision for both compiling an application within a workspace facility and for uploading an application that has been compiled outside of the system. User training will be essential it is expected that the EMA will offer system training. Process and timelinesįor many sponsors, the application process may require internal administration to support sponsor registration and role allocation where required by the CT arrangements (e.g., allocating work to contract resource organizations, affiliates, or personnel). There is provision for cross-referencing to existing applications, which will further reduce the current administrative burden of EU CT applications. The application content and assessment are divided into two parts: Part I contains scientific and medicinal product documentation Part II contains the national and patient-level documentation (see Table A). Note: This article does not cover notifications of milestones or unexpected events that are required by the new regulation. In addition, the regulation defines procedural timelines, harmonizes document requirements, and aims to reduce the administrative burden of applications. This procedure not only combines the content of what can be currently referred to as the “regulatory” and “ethics” applications, but also combines the scientific, technical, and ethical review necessary to receive approval to conduct a CT in the EU. The regulation introduces a single approach for the application and maintenance of a CT authorization, and applies to both single or multiple member state trials. While this is a major change, it is also seen by many as a key benefit. The regulation will be applicable by no later than October 2018. ![]() According to the most recent European Medicines Agency (EMA) confirmation, 1 The regulation’s effective date is dependent on the availability of the portal and its associated database, which are now in development and subject to user acceptance testing by EMA stakeholders. One of the major changes introduced by the European Union (EU) regulation 536/2014 is an application procedure that will require sponsors to apply for authorization to conduct an interventional/low-intervention clinical trial (CT) via a new EU portal. ![]() He procured a drive from his friends at HP and proposed to Bob Belleville that we figure out how to interface it to the Mac as soon as possible, while we negotiate a deal with Sony. George Crow, the analog engineer who designed the Mac's analog board, had come from HP prior to working at Apple and was sold on the superiority of the Sony drives. If we couldn't find a suitable replacement quickly enough, we'd have to slip the entire project indefinitely.įortunately, we were aware of Sony's new 3.5 inch drive that they started to ship in the spring of 1983 through Hewlett-Packard, their development partner. It looked like the Twiggy drive was never going to be reliable or cost effective enough for the Macintosh, but we were stuck without an alternative. We were using a single Twiggy drive as our floppy disk, and we didn't have a hard disk to fall back on. ![]() Meanwhile, the Mac team was beginning to panic. Finally, Lisas were shipped to customers in June 1983, even though there continued to be production and reliability problems with the disk drives. There were problems in a number of areas, but the biggest one was the low yield of the Twiggy drives, whose high error rate greatly limited production. Lisa was announced to great fanfare in January 1983, but it still wasn't ready to ship. Soon, the hard disk became mandatory, upping the minimum price of a Lisa by more than a thousand dollars. Besides, the Lisa operating system designers were used to working on systems that swapped memory from disk, which wasn't really feasible to pull off at floppy disk speeds. The Twiggy drive was also slower than expected, because of the high error rate as well as the way the variable motor speed trick increased seek times, since you had to wait for the speed change to stabilize. As the Twiggy designers encountered unexpected difficulties in achieving an acceptable error rate, Lisa came to rely on the hard drive instead. The Lisa also supported an optional, external hard drive through a built-in parallel port. Instead, the Lisa hardware designers (Paul Baker, Bob Paratore and others) solved the problem by including a little Apple II, with its own memory and microprocessor (but clocked twice as fast), inside the Lisa to control the Twiggy drives. ![]() Twiggy used a Woz-style disk controller, which created a problem for the Lisa designers, since that required exact timing from the microprocessor and therefore couldn't tolerate interrupts, which was perhaps OK for a simple system like the Apple II but was unacceptable for a more sophisticated system like Lisa. The Lisa was designed to include two built-in Twiggy drives, so it made sense for the Macintosh to use Twiggy as well. Twiggy was a fairly ambitious project, more than quadrupling the capacity of standard floppy disks by doubling the data rate (which required higher density media) and employing other innovative tricks like motor speed control, which slowed down the disk rotation speed on the outer tracks to cram more data on them. Woz's Apple II floppy disk design was way ahead of the rest of the industry, so Apple felt confident that it could continue to innovate to extend its lead. At Rod Holt's request, I had written some early diagnostics for Twiggy using an Apple II, but I felt lucky that they asked Rich Williams instead of me to transfer to the disk division as their software guy, since focusing exclusively on disks seemed pretty limiting. Both were intended to be used first by the Lisa project, and eventually across Apple's entire product line. In 1980, Apple reorganized again, splitting off a new "Disk Division" headed by John Vennard, responsible for developing a hard disk code-named "Pippin" and a next generation floppy disk code-named "Twiggy". ![]() Ability to process fields of tag and file name.Auto completion of the date if a partial is entered.Read file header informations (bitrate, time.Can set a field (artist, title.) to all other files.Recursion for tagging, removing, renaming, saving. ![]() Process selected files of the selected directory.Ability to rename files and directories from the tag (using masks) or by loading a text file.Auto tagging: parse filename and directory to complete automatically the fields (using masks).Can edit more tag fields: Title, Artist, Album, Disc Album, Year, Track Number, Genre, Comment, Composer, Original Artist/Performer, Copyright, URL and more.Take a look at what this program has to offer: It features a nive interface and it's also very easy to use. Nevertheless, this one’s free and available to developers to build their own versions.ĮasyTAG is a tool that enables you to view and edit ID3 tags for a wide variety of music files, including MP3, AAC, FLAC, Ogg Vorbis, Monkey's Audio and WavPack formats. The biggest issue you would just face is that compared to other tag editor tools, it doesn’t perform as quickly as them. Using it for the first time isn’t a hassle. It’s straightforward with its interface design despite its appearance. Slow to load but still usefulĪll in all, EasyTAG is a great audio file metadata editor that’s recommended for everyone. This is highly user-friendly even without looking up tutorials or its official website’s documentation-and the fact that it’s an open-source project makes it a desirable choice for developers, as well. Most are either empty fields you can write on, drop-down lists, or toggleable buttons for settings. However, the features themselves are easy to use. In terms of interface design, this tag editor can look a bit bland and boring, despite its streamlined navigation. For file searching, this tool offers CDDB (Compact Disc Database) support, as well-using and servers for manual and automatic searches. It can set selected fields to all other files, undo and redo last changes, auto-complete dates if you typed in a partial one, and even generate a playlist for you. This program also offers an advanced feature such as a recursion function for tagging, removing tags, renaming, saving, and the like. You can directly edit them on this panel and even view and change their images. Lastly, the right panel has all of the metadata information of the currently-selected file. The middle one is for the files themselves, which displays their current filename. The left one contains the tree-based browser that lets you manually select the source location or folder of a file. Highly user-friendlyĮasyTAG’s main interface displays three panels. The program will notify you if you don’t have it and will prompt for an installation. However, take note that you will need GTK+ preinstalled for it to work. Thus, it can be operated by any type of user, whether they’re familiar with tag editors or not. It’s also a cross-platform program that can work on other PC operating systems. This software supports formats such as MP3, MP2, MP4/AAC, FLAC, Ogg Opus, Ogg Speex, Ogg Vorbis, MusePack (MPC), Monkey's Audio (APE), and WavPack. ![]() I really love this game because not only am I able to drive trains, but I am able to edit routes like “City and Country USA” in my own image, as well as get new stuff from the new routes, and or sessions I downloaded, and being able to create my own sessions. Prepare yourself for the most realistic Train Simulator on any mobile device! You can build a fun layout in minutes, faithfully recreate a railroad from days gone by or develop a fully-fledged prototypical route the choice is yours. Trainz Simulator 2 for iPad includes everything you need to build and operate your own dream railroad. Accessibility take Trainz with you anytime, anywhere.īased on the successful PC & Mac franchise, Trainz Simulator 2 allows you to Build and operate the railroad of your dreams. Touch input makes driving Trains, laying tracks, creating layouts and completing scheduled tasks a breeze. Build and customize your own living railroad using our advanced route creation tool called “Surveyor”. Has a lot of cool locomotives and steam trains, and I love the fact I can make my own routes ![]() I would very highly recommend Trainz Simulator 2! The Al traffic is amazing and it is Avery fun scenario. It is very engaging and very fun!! Up The Mountains Part 1 is one of the scenarios that is available for purchase (only 99 cents!), and it is an amazing scenario. This app is absolutely amazing! Although it is not as detailed as computer versions are, it is amazing what they have done considering this for iPads/iPhones. He's a train and iPad lover - so this is perfect! Routes Locos & rolling stock will keep the most demanding rail enthusiasts busy for hours! Trainz 2 is an amazing mobile rail simulation. Enjoy the varied scenery, weather and other adjustments for some great gameplay. Trainz Simulator 2 is for the young, the young at heart or anyone who loves the power of a loco at full throttle! For the latest and greatest experience upgrade to Trainz Simulator 3 - available now.Įxperience being a train driver on a variety of routes throughout the world, choose from a wide range of steam, diesel or electric trains, and create your own rail line with the intuitive world building tools. Some pieces may require sanding or some minor fixes, all of which should be done before applying a coat of paint. Thus, while this paint rarely requires any surface preparation, it is recommended that you thoroughly clean and scrub any dirt or grime off of your piece before painting it. In many cases, chalk paint is used on furniture that is worn and old. This paint is naturally quick-drying, although it will dry more quickly when in a more open space. Thus, it is best to paint your piece of furniture in an airy, open space indoors so as to prevent any outside debris falling onto the wet paint. As you become more adept at using chalk paint, you may want to begin experimenting with more unconventional tools to create interesting finishes.Ĭhalk paint is generally considered to be non-toxic with a very low risk of VOCs. Wax will be required for the protective seal at the end. Brushes and rollers are great staple tools, in addition to tape, stirrers, old rags, sanding paper (if distressing) and even a can opener. You will require a few basic tools when using chalk paint. Some brands may be more appropriate to use on certain surface areas than others, so it is important to choose a chalk paint that will work for the item you wish to refurbish. See our chalk paint review above or do your own research to find a brand that works for you in terms of price, color selection, and usability. It is recommended that you choose a brand of paint that is of a high quality. You do not always have to use chalk paint on antique furniture, however, as this paint can also be used to personalize a mass-produced item or to create a more shabby-chic aesthetic. You cannot begin a painting project without something to paint! Chalk paint is best used on old furniture, as a fresh coat of color can do wonders for a tired chair or set of drawers. The matte, chalky finish of this paint makes it perfect for painting glass mason jars for a cute storage idea.The best chalk paint can be used on both indoor and outdoor pieces, and is therefore a great idea for decorating your old garden pots and planters.You can also use this paint to add a pop of color to your front door! You do not only have to use your chalk paint on furniture, however.This paint will make your old pieces look brand new, complete with an elegant matte-like finish! You can also use the best chalk paint for furniture that is old or unwanted.Chalk paint is ideal for creating a “shabby-chic” look, where a piece of furniture is painted and distressed so as to appear vintage.Chalk paint can be blended easily to create a color gradient or various shades. Any piece of furniture can receive a total makeover simply by giving it a fresh coat of paint. This is the best furniture paint due to its versatility.However, you can also use chalky paint for a variety of other DIY projects! ![]() Most people use the best chalk paint for furniture, particularly in order to revitalize an older piece or to make newer pieces appear weathered and old. You can remedy this by using a primer on the piece. This paint is more porous than others, and may not completely cover the reddish hues of some woods or old stains.If sealing with wax, this process can be strenuous.Once you have finished painting, it needs to be sealed.Some pieces may still need to be prepared or sanded before being painted.This chalk paint is easy to use and quick to dry, making it ideal for DIY projects!Īs is the case with any product, there are a number of pros and cons of chalked paint that will help you to decide if this is the best choice of paint for you. This is the best furniture paint to use when wanting to redecorate an old piece of furniture, as it can even be used on items that have already been painted. Where it is necessary to sand or prime a surface before using most other paints, you can apply chalk paint directly to almost any surface as long as it is clean and dry. The best chalk paint can be used by anyone at a moment’s notice, as it requires little to no preparation. The matte and chalky finish provided by chalk paint has revolutionized the ways a person can decorate their home. ![]()
![]() This cookie is set by GDPR Cookie Consent plugin. This cookie is used for determining whether the user has accepted the cookie consent box. This cookie is set by the provider bidr.io. Aceste cookie-uri asigură funcționalități de bază și caracteristici de securitate ale site-ului web, în mod anonim. Cantecele sunt excelente mijloace mnemonice…Ĭookie-urile necesare sunt absolut esențiale pentru ca site-ul web să funcționeze corect. Acest efect il are muzica si mai tarziu: de exemplu, Coranul se invata recitand. Un alt efect de calmare il are prolactina, prezenta in lacrimi… Daniel Levitin spune ca acesta ar fi motivul pentru care cei deprimati asculta muzica trista, care ii face sa planga si mai si…īebelusii de sapte luni recunosc muzica ce li s-a cantat cu doua saptamani in urma, iar cantecelele din copilarie sunt bune mijloace de memorizare. De ce? Pentru ca are pattern-uri repetitive, de ritm, de motive, si asta ii da un element de predictibilitate pe care limbajul simplu nu il are si care poate fi calmant. Oamenii prefera sa cante impreuna, sa danseze impreuna… Hipotalamusul, amigdala, cortexul motor… Zonele corticale legate de miscare si emotie se aprind cand cantam sau dansam impreuna, iar oxitocina, hormon al linistirii si atasamentului, curge in valuri… Muzica ne face mai sexy… Altfel, cum se explica imensul succes al solistilor rock? Sex appeal-ul celor cu abilitati muzicale e incontestabil, fie ca vorbim despre cei care canta mai mult decat splendid la pian sau de Steve Tyler… In plus, muzica favorizeaza conexiunea sociala. Muzica a evoluat din limbaj, spune si Steven Pinker, psiholog evolutionist american. Orice cultura poseda muzica – asadar, ea are un loc central in identitatea noastra umana. ![]() ![]() Levitin e muzician transformat in neuroscientist (si prieten cu Sting, pe care l-a pus la RMN, in timp ce acesta asculta doua tipuri de muzica: tehno si Bach – pe muzica lui Bach s-au „aprins“ toate zonele placerii din creierul artistului). „Americanii cheltuiesc mai multi bani pe muzica decat pe medicamente ori sex in medie, un american aude cam cinci ore de muzica pe zi“, scrie Daniel Levitin, in The World in 6 Songs. Industria muzicala, la nivel mondial,concureaza serios incasarile industriei porno. Cel mai probabil e ca ar fi util sa asculti, timp de cateva momente, altceva… Cui pe cui se scoate! Din pacate, nu ofera o solutie pentru a scapa de acesti paraziti pe note. Cum altfel se explica un mic refren iritant pe care il auzi dimineata in metrou si de care nu mai poti scapa? Oliver Sachs numeste aceste mici iritari muzicale brainworms. Muzica pare sa locuiasca in creierele noastre, in circuitele noastre neuronale. Stimularea muzicala poate contribui la recuperarea cuiva cu AVC sau la insertia sociala a unui copil cu autism. In mai toate cazurile, par sa aiba loc mici miracole. ![]() Oliver Sachs, neurologul american-vedeta pasionat de muzica clasica si de efectele sale asupra creierului, a studiat in detaliu efectele muzicii asupra celor cu autism, cu accidente vasculare cerebrale, etc. Nu degeaba cercetarile merg in directia meloterapiei si a altor terapii, asociate cu diversele expresii muzicale. Un refren ritmat si un videoclip cu fete frumoase te scoate din depresie. In plus, ne poate schimba in bine dispozitia. Si nu costa prea mult, adica e o stimulare la indemana. Face parte din zgomotul de fond al existentei noastre, ne face viata plina, ne amuza, ne energizeaza, ne da aripi libidoului cand mergem la club, la un dans, sau ne da adevarata dimensiune a unei vieti pasionale, arhaice si bucolice, cand ascultam o Mesecina cantata din suflet de Goran Bregović. Descarcam MP3 fara jena.Į clar: muzica e un produs de care avem nevoie, nu e doar o simpla placere. Dam banii pe concerte cu Dire Straits, ACDC, Metallica, Inna etc. Cantam cu prietenii la distractie, la dus, in jurul unui foc de tabara sau in fata oglinzii. Dar ce este ea si cum am ajus sa o numaram printre nevoile noastre zilnice? Linistea totala parca e stresanta…Īscultam muzica atunci cand facem sport, cand conducem masina, cand gatim sau facem alte treburi. Fie ca e cel mai recent refren simplut al zurliei Inna sau piesele de la Festivalul Enescu, muzica ne marcheaza viata cotidiana. ![]() In any case, I've found Bookshelf to be quite annoying and slow, so I took out some time to figure out the format. ![]() VitalSource Bookshelf Access your eTextbooks with our powerful eReader platform. Get the tools you need to study effectively. Seamless Instant access to over a million online textbooks anytime, anywhere and on any device. Smart Highlight text, take notes, search for specific content. New features are added continually to help you study smarter. VitalSource Bookshelf Supercharges Digital Textbooks Access your course materials on any laptop, tablet, or smartphone device with VitalSource Bookshelf, the textbook app for smarter reading, studying, and learning. Vitalsource Converter is tools to convert bookshelf ebook to PDF file. It take screenshot of page in bookshelf through whole. vbk ebook, and save o pdf file, user can read. ![]() vbk ebook in ipad, tablet or share with friend, it has windows and Mac version, support Bookshelf Ver 6.7.2 and up.Įxtractor.epub for VitalSource Bookshelf. This EPUB file allows you to convert books in VitalBook EPUBBook format into regular EPUB books. PDF and EPUB files can be read in Bookshelf Both file types can be read with a screen reader such as, but not limited to, JAWS and NVDA Readers can resize text using our content controls located at the bottom of the screen or change the zoom percentage of the entire page By sideloading Extractor.epub, the content of other EPUBBooks loaded in Bookshelf can be packaged into a regular EPUB file which you can then use on other ebook readers. While convert vitalbook file to pdf may be too cause is unknown and the only consistent symptom is the pain fiel has made it skin to wake up dormant neck and shoulders area, and muscles to grow. The fact that I cannot print any of my books to PDF to more than 20 pages is pathetic The fact that I cannot print any of my books to PDF to more than 20 pages is pathetic PDF's will always rule over this inferior app and vbk extensions. The VitalSource Bookshelf application lets you perform a number of. there is no conversion program that can convert a VBK file into a PDF file. Bookshelf takes plain text (TXT) files and displays. This program is an alternative PDF reader that allows you to browse your PDF documents in an amusing way. Vitalsource bookshelf to pdf converter vistalsource drm removal, vitalsource bookshelf to pdf converter vistalsource drm removal, convert vitalsource bookshelf to pdf by vitalsource converter pro. vitalsource drm removal convert vbk to pdf. the easiest way to convert vitalsource vbk to pdf. VitalSource Bookshelf's eTextbooks need to be downloaded to your computer. The file size of a textbook can range from a few MB to 1GB depending on the type of book, size of book, and contents of the eTextbook. Once you have sucessfully downloaded the eTextbook to your computer you do not need to be connected to the internet to view it again. Progressive retinal atrophy (PRA) is a degenerative eye disorder and is detectable years before the dog shows any signs of blindness, though that is the eventual result. We Found the Best Dog Food for Large Breed Puppies for 2022.The Best Dog Food for Small Dogs (Puppy, Adult, Senior) for 2022 – Reviewed and Ranked.The Best Dog Food for Labrador Retrievers for 2022 - (Senior, Puppy, and Adult). ![]() The Best Wet Food for Senior Dogs for 2022.Health and Entertainment for your Dachshund In many cases, this condition can be controlled by medication which can be provided by a veterinarian. Epilepsy in dogs can be genetic or brought about by a hard fall or blow to the head. This can lead to dehydration, bladder issues, and paralysis in certain cases. This is also the most common spinal disease in dogs. The most common health issue in doxies is intervertebral disc disease. The standard height for doxies is 8 to 9 inches tall at the shoulders. Standard doxies usually weigh between 16 and 32 pounds while their miniature counterparts may weigh under 11 pounds at full maturity. See all of our entertaining and insightful animal articles. Dachshund vs Doxin: Is There a Difference?. ![]()
They can equip their character with military equipment including armored vests, armored rigs, and ballistic helmets. Weapons can be built by the player by customizing all its constituent parts, such as selecting the dust cover, grip, stock and scope. ![]() Combat Įscape from Tarkov 's gameplay has been compared to military simulation games such as the ARMA series. These bonuses include reducing the cooldown timer to play as a Scav, increasing experience gained, and the ability to craft items. Players have an upgradeable "Hideout" living area, which is an underground bomb shelter that – once upgraded with scavenged or purchased materials – gives the players in-game bonuses. These traders also task the player with completing quests which increase their trader loyalty, enabling access to more items and quests. While not in a raid, players can sell unwanted loot to traders or other players via the flea market and purchase new equipment. Each raid lasts between 15 and 45 minutes depending on the map, and may contain up to 14 players. After finishing a scavenger raid, there is a cooldown timer until the mode becomes available again for the player. In scavenger raids (known as scav runs) players are given a random set of equipment, instead of items from their personal stash, and enter a raid that is already in progress at a random location. Players can insure weapons and equipment they brought in which enables that gear to be returned to them if not taken by other players. When players die in a raid, they lose everything, including loot and the equipment they brought into the raid. The game has a minimal HUD, with little on-screen information presented to the player. ![]() In addition to combat, players can also find loot in these maps such as firearms, equipment, and armor, and once extracted, can store their loot in a stash to use in future raids or can be sold to other players in a virtual flea market if having a "found in raid" status. In addition to these standard extractions, players are also given the opportunity to use "optional" extraction points near the middle of the map, but in order to do so you must meet various requirements per extract such as paying roubles (the primary in-game currency), not having a backpack, or having certain items equipped on their character. Once in-game, the players are given an extraction point on the other side of the map, and must fight against other players and non-player characters to reach that point in order to escape. In these raids, players can choose to play solo or in groups and spawn on one side of a variety of maps to choose from in the game. In its current state, Escape from Tarkov incorporates three different modes for the players to play: online PMC raids, Scav (short for "scavenger") raids, and a temporary offline mode. The developers of Escape from Tarkov refer to the game as a realistic and hardcore first-person shooter, survival video game that borrows elements from massively multiplayer online games. |