[Book] How to Write a Drug/Medical Device Approval Application ★Free Price★

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. ...

others