• ¥5,400

発行者による作品情報

Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e.g. scheduling, source data, department/functions involved in document preparation/review, appropriate timelines and planning activities), ending with a generic model document compliant with the current guidelines, which can be modified to meet specific company and product requirements.

ジャンル
職業/技術
発売日
2012
6月22日
言語
EN
英語
ページ数
288
ページ
発行者
Wiley
販売元
John Wiley & Sons, Inc.
サイズ
1.7
MB