{"product_id":"pharmacovigilance-medical-writing-justina-orleans-lindsay-9781119967262","title":"Pharmacovigilance Medical Writing","description":"\u003ci\u003ePharmacovigilance Medical Writing\u003c\/i\u003e 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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Justina Orleans-Lindsay\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1119967260\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781119967262\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Wiley-Blackwell\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 08\/13\/2012\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 288\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.65lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 8.40h x 5.40w x 0.50d","brand":"Justina Orleans-Lindsay","offers":[{"title":"Paperback","offer_id":44311193551103,"sku":"9781119967262","price":65.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_707a5ad6-0a58-44e7-bd0d-43a052176083.jpg?v=1695721542","url":"https:\/\/www.whiterainbookhouse.com\/products\/pharmacovigilance-medical-writing-justina-orleans-lindsay-9781119967262","provider":"WR Book House","version":"1.0","type":"link"}