{"product_id":"pharmacovigilance-medical-writing-a-good-practice-guide-9781119967262","title":"Pharmacovigilance Medical Writing: A Good Practice Guide","description":"\u003cp\u003e • Author(s): Justina Orleans-Lindsay\u003cbr\u003e • Publisher: Wiley-Blackwell\u003cbr\u003e • Publisher Imprint: Wiley-Blackwell\u003cbr\u003e • BISAC: Pharmacology\u003c\/p\u003e\u003cp\u003e\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.\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Paperback","offer_id":45045967126679,"sku":"9781119967262","price":5981.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9781119967262.webp?v=1767262771","url":"https:\/\/atlanticbooks.com\/products\/pharmacovigilance-medical-writing-a-good-practice-guide-9781119967262","provider":"Atlantic Books","version":"1.0","type":"link"}