Sabtu, 18 Januari 2014

[I475.Ebook] Download Ebook Comprendre Michael Porter. Concurrence. Stratégie.From EYROLLES

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  • Dimensions: 5.55" h x .59" w x 8.86" l,
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Selasa, 14 Januari 2014

[G734.Ebook] Get Free Ebook Medical Device Development: Regulation and Law, by Jonathan S. Kahan

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Medical Device Development: Regulation and Law, 2nd Edition, is the must-have resource for the novice or veteran medical device regulatory affairs professional. This practical reference provides the most comprehensive and updated analysis of US medical device and diagnostics development and approval requirements anywhere. This book also features in-depth analysis on how emerging developments and trends are reshaping medical device and combination product regulations in the US. The second edition of this popular and authoritative resource addresses the latest regulatory and legal developments that guide how medical devices are developed today: * The Medical Device User Fee and Modernization Act of 2002, including user fees, third party inspections, reprocessed single use devices, and the establishment of the Office of Combination Products. * The Food and Drug Administration Amendments Act of 2007, including unique device identifiers, ClinicalTrials.gov registration, pediatric device promotion, and postmarket surveillance and medical device reporting changes. * The current and future landscape of electronic 510(k) and PMA submissions. New chapters and features in the second edition include: * Medical Device Compliance and Postmarket Surveillance requirements. * Quality System Regulation, including management controls, design controls, risk analysis and corrective and preventive action, and other QSR provisions. * In Vitro Diagnostics, including IVD clinical studies, ASR regulation, LDTs, CLIA, and IUO/RUO requirements. * Combination Products and Product Jurisdiction, including a description of FDA s jurisdictional decision-making for single entity products, the establishment of the Office of Combination Products and its jurisdiction and processes, with a detailed discussion of the new definition of the primary mode of action. * A glossary and comprehensive index of terms and concepts.

  • Sales Rank: #1098330 in Books
  • Published on: 2009-08-17
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.50" h x 6.50" w x 1.50" l, 2.54 pounds
  • Binding: Hardcover
  • 550 pages

About the Author
Jonathan S. Kahan, Partner, Hogan & Hartson LLP in Washington, D.C., is a co-director of the firm's food, drug, medical device, and agriculture group. Jonathan has been practicing in FDA law for 35 years. His practice focuses primarily on assisting medical device companies in navigating the U.S. Food and Drug Administration (FDA) regulatory process. He also has an extensive practice in combination products, which includes combinations of drugs, devices, and biologics. In addition to the daily counseling of clients in FDA-related matters, he represents many clients in administrative hearings and trials, and in the federal courts. Jonathan has published numerous law review and other articles concerning FDA regulatory issues.

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5 of 5 people found the following review helpful.
Very Inciteful
By Richard Mackenzie
Great book for a beginner learning about process, or an experienced practitioner in the field. I used prior addition, until i realized it was updated - i testify on matters of value in the field of medical devices, and nothing helps the court understand faster - than a text book you can cite documenting the process of a 510(k) application or a PMA!

1 of 1 people found the following review helpful.
Great Book for Medical Device Knowledge
By MAB
I purchased this book for school and learned so much from it that I'm keeping it and not selling it back. If you have limited knowledge and are in the Industry of Biotechnology and want to learn about Medical Device Regulations etc. this is the book for you.

0 of 0 people found the following review helpful.
Required it for school. Great book
By C. Jacob
Very thorough information on medical devices. I have been using quite frequently for classes. Includes historical laws that have been implemented.

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Minggu, 12 Januari 2014

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Téa Stilton est la sœur de Géronimo Stilton, le célèbre écrivain. Elle aime aussi écrire des histoires. Ses livres racontent les aventures incroyables qu'elle partage avec ses cinq amies et intrépides enquêteuses: les Téa Sisters!
Le code du dragon: «Que cachent les souterrains de l'antique Collège de Raxford? Et qui a enlevé Hans Ratello? Pour résoudre cette énigme, il faut un groupe de filles vraiment spéciales: les Téa Sisters! Voici l'histoire de leur première et fantastique aventure...»

  • Sales Rank: #3178888 in Books
  • Published on: 2006-05-01
  • Original language: French
  • Number of items: 1
  • Dimensions: .90" h x 5.60" w x 8.30" l, .80 pounds
  • Binding: Paperback

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Selasa, 07 Januari 2014

[I525.Ebook] Free Ebook Empirical Legal Research: A Guidance Book for Lawyers, Legislators and Regulators, by Frans Leeuw, Hans Schmeets

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'In 1788 John Adams created a sublime ambition for all nations - 'a government of laws and not of men'. In the intervening years we have come to learn that legislation itself works through the interpretations of the many men and women who work on the inside and the outside of the law. Effective regulation thus depends not only on scrupulous legal analysis, with its appeal to precedent, conceptual clarity and argumentation, but also on sound empirical research, which often reveals diversity in implementation, enforcement and observance of the law in practice. In this outstanding, worldly-wise book Leeuw and Schmeets demonstrate how to bridge the gap between the letter and the delivery of the law. It is packed with examples, cases and illustrations that will have international appeal. I recommend it to students and practitioners engaged across all domains of legislation and regulation.'
- Ray Pawson, University of Leeds, UK


Empirical Legal Research describes how to investigate the roles of legislation, regulation, legal policies and other legal arrangements at play in society. It is invaluable as a guide to legal scholars, practitioners and students on how to do empirical legal research, covering history, methods, evidence, growth of knowledge and links with normativity. This multidisciplinary approach combines insights and approaches from different social sciences, evaluation studies, Big Data analytics and empirically informed ethics.

The authors present an overview of the roots of this blossoming interdisciplinary domain, going back to legal realism, the fields of law, economics and the social sciences, and also to civilology and evaluation studies. The book addresses not only data analysis and statistics, but also how to formulate adequate research problems, to use (and test) different types of theories (explanatory and intervention theories) and to apply new forms of literature research to the field of law such as the systematic, rapid and realist reviews and synthesis studies. The choice and architecture of research designs, the collection of data, including Big Data, and how to analyze and visualize data are also covered. The book discusses the tensions between the normative character of law and legal issues and the descriptive and causal character of empirical legal research, and suggests ways to help handle this seeming disconnect.

This comprehensive guide is vital reading for law practitioners as well as for students and researchers dealing with regulation, legislation and other legal arrangements.

  • Sales Rank: #3524545 in Books
  • Published on: 2016-05-25
  • Original language: English
  • Dimensions: 9.50" h x 6.50" w x 1.00" l,
  • Binding: Hardcover
  • 320 pages

Review
In a world increasingly seeking laws that are evidence-based, this book provides a much needed and original approach to empirical legal studies. The book masterfully shows how empirical work is relevant to the law and offers highly accessible guidance on how to do empirical work in law. This book makes indispensable reading for academics, policymakers and practitioners alike. --Jan M. Smits, Maastricht University, the Netherlands

This thoughtful book provides an excellent guide for lawyers and legislators to empirical research which assumes increasing importance in an evidence-based political and legal economy. Set in the context of a history of empirical research, the authors offer a comprehensive and accessible account of qualitative and quantitative methods, data collection and theory-building infused with practical examples. I strongly recommend this intelligent and informative book. --Mike McConville, The Chinese University of Hong Kong

About the Author
Frans L. Leeuw, Professor of Law, Public Policy and Social Science Research, Maastricht University; Faculty of Law and Director, Security and Justice Research Center (WODC), the Hague

with Hans Schmeets, Professor in Social Statistics, Maastricht University and Senior Researcher, Statistics Netherlands, the Netherlands

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Don't Let the Pigeon Drive the Bus!, by Mo Willems

When a bus driver takes a break from his route, a very unlikely volunteer springs up to take his place-a pigeon! But you've never met one like this before. As he pleads, wheedles, and begs his way through the book, children will love being able to answer back and decide his fate.

In his hilarious picture book debut, popular cartoonist Mo Willems perfectly captures a preschooler's temper tantrum.

  • Sales Rank: #1196 in Books
  • Brand: Hyperion Press
  • Model: 9780786819881
  • Published on: 2003
  • Released on: 2003-04-01
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.25" h x .43" w x 9.25" l, .70 pounds
  • Binding: Hardcover
  • 40 pages
Features
  • 2 years & up. A belly-laugh picture book with a smidgeon of pigeon!
  • When the bus driver goes away Pigeon comes to play
  • Children will love deciding the fate of this crazy little bird that thinks he can drive
  • Each hilarious scenario is full of the over-the-top pleads and wheedles of Pigeon
  • A fun way to learn about human behavior. Hardcover. 40 pages.

Amazon.com Review

Amazon Exclusive: The Pigeon: A Life in Pictures
(Click on images to enlarge)

Back in 1993, I was cartooning for a ’zine. Due to a lack of other material, we decided to make the December issue a sketchbook with just my cartoons. I have been producing small cartoon and story sketchbooks for clients and pals every year since then. In 1998, my sketchbook featured a new character, the Pigeon. Born in the margins of a 1997 notebook filled with potential picture book ideas, he was complaining that his ideas were better than mine. To mollify him, I put him in that year’s sketchbook. The original sketchbook was much longer than the final published volume, but some of the lines were the same. In late 1999, an agent essentially agreed with the Pigeon and rejected my picture book ideas. She suggested I revisit my sketchbook with an eye to turning it into a picture book. My wife was working at a school library at the time and had read the sketchbook to her kids, who had enjoyed it. So I suppose it wasn’t too crazy an idea. I started to revise the layout and work with color. At the end of 2001, after several dozen rejections because the book was “unusual,” an editor decided that “unusual” was a good thing. Plus, it made her laugh. I began reworking and rewriting. The Pigeon was now starting to look more like his mature self. Don’t Let the Pigeon Drive the Bus! was published in April 2003 and, to my surprise, proved to be popular quite quickly. Thankfully, that Pigeon doodle in the notebook back in 1997 was so insistent. He was right!

From School Library Journal
PreSchool-Grade 2-A brilliantly simple book that is absolutely true to life, as anyone who interacts with an obdurate three-year-old can attest. The bus driver has to leave for a while, and he makes one request of readers: "Don't let the pigeon drive the bus." It's the height of common sense, but the driver clearly knows this determined pigeon and readers do not-yet. "Hey, can I drive the bus?" asks the bird, at first all sweet reason, and then, having clearly been told no by readers, he begins his ever-escalating, increasingly silly bargaining. "I tell you what: I'll just steer," and "I never get to do anything," then "No fair! I bet your mom would let me." In a wonderfully expressive spread, the pigeon finally loses it, and, feathers flying and eyeballs popping, screams "LET ME DRIVE THE BUS!!!" in huge, scratchy, black-and-yellow capital letters. The driver returns, and the pigeon leaves in a funk-until he spies a huge tractor trailer, and dares to dream again. Like David Shannon's No, David (Scholastic, 1998), Pigeon is an unflinching and hilarious look at a child's potential for mischief. In a plain palette, with childishly elemental line drawings, Willems has captured the essence of unreasonableness in the very young. The genius of this book is that the very young will actually recognize themselves in it.
Dona Ratterree, New York City Public Schools
Copyright 2003 Reed Business Information, Inc.

From Booklist
PreS. In his winning debut, Willems finds the preschooler in a pigeon: a cajoling, tantrum-throwing, irresistible bird. "I've got to leave for a little while," says a uniformed bus driver as he strolls off the opening pages. "I thought he'd never leave," says the big-eyed pigeon as he marches onto the next spread and begins his campaign to drive the bus. His tactics, addressed to an unseen audience, are many: he reasons ("I tell you what: I'll just steer"); he whines ("I never get to do anything!"); he's creative ("Let's play 'Drive the Bus'! I'll go first"); he bargains ("C'mon! Just once around the block!"). Finally he erupts in a feather-flying tantrum, followed by a drooping sulk that ends only when a truck arrives, and new road fantasies begin. Librarians may struggle with the endpapers, which contain important story content, but the design is refreshingly minimal, focusing always on the pigeon; he's the only image on nearly every earth-toned spread. Willems is a professional animator, and each page has the feel of a perfectly frozen frame of cartoon footage--action, remarkable expression, and wild humor captured with just a few lines. Preschoolers will howl over the pigeon's dramatics, even as they recognize that he wheedles, blows up, and yearns to be powerful just like they do. Gillian Engberg
Copyright © American Library Association. All rights reserved

Most helpful customer reviews

405 of 424 people found the following review helpful.
One of the funniest picture books you'll ever peruse
By E. R. Bird
Because this book won a 2003 Caldecott Honor, you're probably going to hear a lot of people complaining about it. "Oh the art isn't beautiful". "Oh my four-year-old child could've drawn it". "Oh it isn't Caldecott-worthy" (whatever that may mean). The fact of the matter is, I was a little shocked too. This book won a Caldecott honor? The one where an amusing pigeon tries every bit of persuasion he can think of to wheedle himself into the driving seat of a bus? Now I've loved this book since it was first published. When I first read it I laughed out loud. Quick! Recite the children's books you love that make you laugh out loud! Not so easy to think of, are they? So I've returned to this little treasure in the hopes of discovering why that Caldecott nominating committee loved this book as much as my pretty self. Could it have been the artwork? Deceptively simple is the best way to describe its style. The pigeon isn't exactly a Michaelangelo. He's drawn with thick black lines, shaded in with blue and yellow. But has a Michaelangelo ever really amused you? Look a little closer at this pigeon and you realize the book's genius. His oversized eyeballs exquisitely display every emotion possible. From sweet and innocent to consumed with an all-encompassing rage. The pages wherein the pigeon completely freaks out and screams at the top of his lungs, "LET ME DRIVE THE BUS!!!" is the temper tantrum of a two-year-old rendered into an aviary form.
But do kids like this book? Well, ladies and gentlemen, the answer is yes. In fact, clever readers let the kids hearing this tale say, "NO!" every time the pigeon tries a new tactic. When the pigeon says, "Please", the kids say no. When the pigeon says, "I tell you what: I'll just steer", the kids say no. When the pigeon says, "Hey, I've got an idea. Let's play `Drive the Bus'. I'll go first", the kids say no. And when Mr. Pigeon collapses in a fury, the kids do not relent. Finally, they have been placed in the position of their parents. They get to tell someone exactly what he cannot do. And they love it.
In the end, it's hilarious. Who can resist this foul when he pulls every trick out of his feathery bag? From, "How `bout I give you five bucks", to a mock-innocent wide-eyed, "I have dreams you know!". In the end, the pigeon goes on to bigger and better dreams (complete with CB radio) and the children reading the story know they've participated in the happy ending. Joy all around. Is this book deserving of a Caldecott Honor? No ladies and gentlemen. It is deserving of a Caldecott MEDAL. But like the pigeon's, this is just a dream.

128 of 141 people found the following review helpful.
Simply Hilarious!
By David LaRochelle
Truly a masterpiece! After many readings, this story still makes me laugh out loud. With only a few simple lines and a minimal amount of dialouge, Mo Willems has created a memorable character in this coniving pigeon who will do anything to drive a bus.
The local librarian told me that this book was a big hit at story hour, with the children actively telling the pigeon "No! You can't drive the bus!" Maybe I still have the mind set of a preschooler, because I found it just as entertaining, so much so that my best friend gave it to me for my 43rd birthday. In my opinion, it's one of the best children's books of the year.
True story.

60 of 64 people found the following review helpful.
As much fun for me as for my four-year-old!
By Chris B.
My four-year-old has gone totally gah-gah over this book (we've read it ever night for the past two weeks since checking it out at the library)! Most of the picture books she's attracted to have brightly colored, detailed illustrations. In contrast, Don't Let the Pigeon Drive the Bus utilizes simple line drawings (with a hip 60's flair) in light, cool-toned hues. Initially, I thought the rather plain presentation might not hold my daughters interest, but just the opposite has proved to be true -- rather than spreading her attention all over the page, she concentrates on the subject at hand (usually the pigeon, sometimes the bus driver) and what he is saying. She laughs hysterically at the way in which the pigeon presents his various arguments for driving the bus. She says, "Mom, he sounds just like me when I try to talk you into letting me do things that you say I'm not old enough to do yet." She also says she likes how the pigeon is always looking at us when he talks.

This is a book adult readers will enjoy every bit as much as the young listeners they're reading to.

See all 698 customer reviews...

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Minggu, 05 Januari 2014

[C515.Ebook] Ebook Download G. Henle Verlag Rondo Capriccioso Op. 14 Piano Solo , by Mendelssohn, by Hal Leonard

Ebook Download G. Henle Verlag Rondo Capriccioso Op. 14 Piano Solo , by Mendelssohn, by Hal Leonard

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G. Henle Verlag Rondo Capriccioso Op. 14 Piano Solo , by Mendelssohn, by Hal Leonard

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G. Henle Verlag Rondo Capriccioso Op. 14 Piano Solo , by Mendelssohn, by Hal Leonard

Ullrich Scheideler has edited one of Mendelssohn's most important and beautiful piano works, comparing it again with the sources. Henle Publishers is now issuing it in a revised edition with his comprehensive commentary. The sparkling bravura piece was called an Etude in the first version of 1828. Two years later Mendelssohn wanted to present the work to the young piano virtuoso Delphine von Schauroth, whom he was courting at the time. He reworked it under the new title Rondo capriccioso, making it even more brilliant and adding a moving introductory adagio (thus described in a letter to Fanny). In this form, the work still presents all good pianists with a rewarding challenge.

  • Sales Rank: #1177647 in Books
  • Brand: G. Henle Verlag
  • Model: 51480919
  • Published on: 2009
  • Binding: Sheet music
Features
  • BOOK24 pagesSize: 12" x 9-1/4"Editor: Ullrich Scheideler

Most helpful customer reviews

2 of 3 people found the following review helpful.
Perfect for the advancing student to learn to play with taste, power, and speed.
By Craig Matteson
The Mendelssohn family was wealthy from its banking interests. They produced two wonderful prodigies in the same generation: Felix, who went on to become one of the world's great musicians, composers, pianists, and conductors. But his older sister, Fanny, was also a brilliant musician and composer. However, because she was both female and from a wealthy family, it was considered unseemly for her to have a public career. Felix did help promote some of her works. Learning her story is quite interesting, as is taking time to understand the deep love between Fanny and Felix. They each died young of strokes and Felix only about six months after Fanny.

Felix was one of the truly great child prodigies the Western musical world has ever known. He ranks with the more famous Mozart. And unlike most child prodigies, he actually matured into a greater musician than he was as a child. While he was popular throughout the nineteenth and early twentieth centuries, after World War II, his reputation underwent revision for the worse, but shows signs of a just revival. I have always loved his music and admire him endlessly.

Felix composed this brilliant work when he was just fifteen and it has been a staple for students and some performers ever since. It is worth learning and performing. Students can gain a great deal by learning it. The Andante invites a sense of tone and drama that must be expressed without going over the top, as young people are wont to do.

The Presto leggiero is a terrific opportunity for a student to learn to play very fast with lightness and control. What is very nice about this work is that the music repeats in a way that allows the student to learn the work and master the technique without have to learn oceans of material.

In other words, the advancing student will be challenged and invited to improve without being crushed under the weight and demands of the work.

This is a terrific edition and I recommend it strongly as I do all Henle editions.

Reviewed by Craig Matteson, Saline, MI

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Kamis, 02 Januari 2014

[Q873.Ebook] PDF Ebook CLIL: Content and Language Integrated Learning, by Do Coyle, Philip Hood, David Marsh

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CLIL: Content and Language Integrated Learning, by Do Coyle, Philip Hood, David Marsh

CLIL (Content and Language Integrated Learning) has emerged since the millennium as a major trend in education. Written by Do Coyle, Philip Hood and David Marsh and drawing on their experience of CLIL in secondary schools, primary schools and English language schools across Europe, this book gives a comprehensive overview of CLIL. It summarises the theory which underpins the teaching of a content subject through another language and discusses its practical application, outlining the key directions for the development of research and practice. This book acknowledges the uncertainty many teachers feel about CLIL, because of the requirement for both language and subject knowledge, while providing theoretical and practical routes towards successful practice for all.

  • Sales Rank: #530939 in Books
  • Published on: 2010-04-30
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.69" h x .39" w x 7.44" l, .87 pounds
  • Binding: Paperback
  • 184 pages

Most helpful customer reviews

0 of 0 people found the following review helpful.
"Using languages to learn, and learning to use languages"
By Eunice Hee-Jung Kang
CLIL is a vaild educational pradiem, particularly in terms of teacher development. First of all,I believe that CLIL encourages professional mobility and gives the benefits of naturalistic early language learning.
CLIL integrates the content, language and skills. It is teacher's decision when, why and how he/she might wish to emphasise any one of these elements above the other.
It is the best option for teachers and students in teaching and learning any foreign languages.
That's why I gave 5 stars! I love it.

0 of 0 people found the following review helpful.
Five Stars
By César Pablo
It's an interesting book full of concepts that anyone who wants to start using CLIL can turn to.

0 of 0 people found the following review helpful.
A good way to start
By Martin J. Caicedo Pereira
Good book if you want to start a clil road, you might want to customize it or look for something more specific such as lesson plans, somwhere else. More best practices, examples and case studies would have been of help.

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