Guidebook for Drug Regulatory Submissions


Book Description

Destined to become every regulatory director's essential desktop companion Professionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tools, and advice including suggestions for preparation, checklists for submission, an FDA evaluation tool for review, and copies of relevant FDA guidelines. As well, vital information is provided on the most common types of submissions, including: Meeting Requests Orphan Drug Applications Investigatory New Drug Applications (INDAs) New Drug Applications (NDAs) 505(b)2 NDAs Abbreviated New Drug Applications (ANDAs) Annual Report This reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change the general nature and specific aspects of the submissions process over the near future. In addition, retired Canadian trade consul and regulatory consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia. Guidebook for Drug Regulatory Submissions is more than a useful guide—it is an essential tool to be kept on the desk of every regulatory director, submissions manager, vice president of Regulatory Affairs, and Food and Drug Administration reviewer responsible for the process of drug regulatory submissions.




Destination Japan


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Destination Japan


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Covers: marketing strategy, business customs and practices, Japanese government procurement, Japanese testing, standards and certification and export financing. Also focuses on property protection rights, including patents, trademarks, copyrights, designs, trade secrets and other intellectual property rights in Japan.




Illustrated World ...


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Japan Trade Concessions


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The Technical World


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Guidelines for Preparing Patent Landscape Reports


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These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks.




Handbook of Japanese Applied Linguistics


Book Description

Applied linguistics is the best single label to represent a wide range of contemporary research at the intersection of linguistics, anthropology, psychology, and sociology, to name a few. The Handbook of Japanese Applied Linguistics reflects crosscurrents in applied linguistics, an ever-developing branch/discipline of linguistics. The book is divided into seven sections, where each chapter discusses in depth the importance of particular topics, presenting not only new findings in Japanese, but also practical implications for other languages. Section 1 examines first language acquisition/development, whereas Section 2 covers issues related to second language acquisition/development and bilingualism/multilingualism. Section 3 presents problems associated with the teaching and learning of foreign languages. Section 4 undertakes questions in corpus/computational linguistics. Section 5 deals with clinical linguistics, and Section 6 takes up concerns in the area of translation/interpretation. Finally, Section 7 discusses Japanese sign language. Covering a wide range of current issues in an in an in-depth, comprehensive manner, the book will be useful for researchers as well as graduate students who are interested in Japanese linguistics in general, and applied linguistics in particular. Chapter titles Chapter 1. Cognitive Bases and Caregivers' Speech in Early Language Development (Tamiko Ogura, Tezukayama University) Chapter 2. Literacy Acquisition in Japanese Children (Etsuko Haryu, University of Tokyo) Chapter 3. Age Factors in Language Acquisition (Yuko Goto Butler, University of Pennsylvania) Chapter 4. Cross-lingual Transfer from L1 to L2 Among School-age Children (Kazuko Nakajima, University of Toronto) Chapter 5. Errors and Learning Strategies by Learners of Japanese as an L2 (Kumiko Sakoda, Hiroshima University/NINJAL) Chapter 6. Adult JFL Learners' Acquisition of Speech Style Shift (Haruko Minegishi Cook, University of Hawai'i at Manoa) Chapter 7. Japanese Language Proficiency Assessment (Noriko Kobayashi, Tsukuba University) Chapter 8. The Role of Instruction in Acquiring Japanese as a Second Language (Kaoru Koyanagi, Sophia University) Chapter 9. The Influence of Topic Choice on Narrative Proficiency by Learners of Japanese as a Foreign Language (Masahiko Minami, San Francisco State University) Chapter 10. CHILDES for Japanese: Corpora, Programs, and Perspectives (Susanne Miyata, Aichi Shukutoku University) Chapter 11. KY Corpus (Jae-Ho Lee, Tsukuba University) Chapter 12. Corpus-based Second Language Acquisition Research (Hiromi Ozeki, Reitaku University) Chapter 13. Assessment of Language Development in Children with Hearing Impairment and Language Disorders (Kiyoshi Otomo, Tokyo Gakugei University) Chapter 14. Speech and Language Acquisition in Japanese Children with Down Syndrome (Toru Watamaki, Nagasaki University) Chapter 15. Revisiting Autistic Language: Is "literalness" a Truth or Myth? Manabu Oi (Osaka University/Kanazawa University) Chapter 16. Towards a Robust, Genre-based Translation Model and its Application (Judy Noguchi, Mukogawa Women's University; Atsuko Misaki, Kwansei Gakuin University; Shoji Miyanaga, Ritsumeikan University; Masako Terui, Kinki University) Chapter 17. Japanese Sign Language: An Introduction (Daisuke Hara, Toyota Technological Institute) Chapter 18. Japanese Sign Language Phonology and Morphology (Daisuke Hara, Toyota Technological Institute) Chapter 19. Japanese Sign Language Syntax (Noriko Imazato, Kobe City College of Technology) Chapter 20. Sign Language Development and Language Input (Takashi Torigoe, Hyogo University of Teacher Education)




Guide to Japanese Reference Books


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