{"product_id":"pharmacovigilance-medical-writing-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\u003cbr\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e\u003cb\u003eJustina Orleans-Lindsay\u003c\/b\u003e BSc, MSc, PhD is a Director of Acadustri (Medical Writing) Limited and Visiting Lecturer in pharmacovigilance at the University of Hertfordshire, UK.\u003c\/p\u003e\u003cbr\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":50848682180882,"sku":"9781119967262","price":60.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0831\/4771\/8930\/files\/img_af9d87f0-be00-4922-8a17-3a2173e4abeb.jpg?v=1737380285","url":"https:\/\/surprise-castle.myshopify.com\/products\/pharmacovigilance-medical-writing-9781119967262","provider":"Surprise Castle","version":"1.0","type":"link"}