[Book] How to Write a Drug/Medical Device Approval Application ★Free Price★
How to Write and Organize a Pharmaceutical/Medical Device Approval Application
List price (catalog price): 80,000 yen (excluding tax) ⇒ ⇒ Selling price (free price): 30,000 yen (excluding tax)
We will sell books that have been published for several years at a low price as a free price. -------------------------------- 【Title】 How to Write and Organize Approval Applications for Pharmaceuticals/Medical Devices ~ How to Obtain Essential Data and Information for Review ~ ☆ Make the most of over 10 years from development to approval and hundreds of billions of yen in development costs!! ~ Make the reviewers say and feel that it was easy to review! ~ -------------------------------- ◆ Six Points This Book Solves! ◆ 1. From collecting evidence on the quality, safety, and efficacy of pharmaceuticals and medical devices to organizing the final deliverables such as applications and notifications! 2. How to compile application documents that are easy to read, persuasive, and mindful of the reviewer's perspective, without excess or deficiency! 3. What points are considered compliant during GCP compliance inspections, compliance document inspections, and GPSP compliance inspections, including preparation, on-the-day responses, and investigations? 4. Tips on the timing of face-to-face advice, how to ask questions, and how to rehearse! 5. The validity of the data to be published... 6. ...
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basic information
Table of Contents Chapter 1: How to Obtain and Organize Data and Information for Drug Clinical Trial Applications Chapter 2: How to Obtain and Organize Data and Information for Drug Application Document Preparation Chapter 3: How to Obtain and Organize Data and Information Related to Non-Clinical Studies Chapter 4: How to Obtain and Organize Data and Information Related to Clinical Studies Chapter 5: Key Points of Development Regulatory Strategy Chapter 6: Key Points to Consider Regarding Regulations on Drug Quality (CMC) Chapter 7: Key Points for Obtaining High Drug Prices and Insurance Coverage in Various Countries and for Different Products Chapter 8: Key Points for Obtaining and Organizing Data and Information by Product Type Chapter 9: Key Points for Data Acquisition Required for Each Disease ● Published on June 30, 2014 ● Format: A4, 491 pages ● Authors: 79 ● For more details, please download the catalog or contact us.
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30,000 yen (excluding tax) List price (catalog price): 80,000 yen (excluding tax) ⇒ ⇒ Selling price (free price): 30,000 yen (excluding tax)
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The Technical Information Association works to shape information for engineers and researchers. We research what kind of information engineers and researchers active in fields such as "research and development," "materials," "electronics," and "pharmaceuticals/medical devices" need, and create products such as seminars, books, and distance learning courses!