{"product_id":"pharmacovigilance-medical-writing-a-good-practice-guide-paperback-softback-9781119967262","title":"Pharmacovigilance Medical Writing; A Good Practice Guide (Paperback \/ softback) 9781119967262","description":"\u003cfont face=\"Georgia\"\u003e\r\n\u003cp\u003e\u003cfont size=\"6\"\u003ePharmacovigilance Medical Writing\u003c\/font\u003e\u003cbr\u003e\r\n\u003cfont size=\"5\"\u003eA Good Practice Guide\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\r\n\u003cp\u003e\u003cfont size=\"4\"\u003eJustina Orleans-Lindsay (Author)\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e9781119967262, Wiley\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003ePaperback \/ softback, published 27 July 2012\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e288 pages\u003cbr\u003e21.6 x 14 x 1.4 cm, 0.308 kg\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\r\n\u003cp align=\"justify\"\u003e\u003cem\u003e\u003cfont size=\"3\"\u003e\u003cp\u003e“This book is well structured and should prove useful for pharmacovigilance scientists and writers to have a reference text and checklist for regulatory pharmacovigilance documentation requirements.”  (\u003ci\u003ePharmaceutical Journal\u003c\/i\u003e, 9 February 2013)\u003c\/p\u003e\u003c\/font\u003e\u003c\/em\u003e\u003c\/p\u003e\r\n\r\n\u003cp align=\"justify\"\u003e\u003cstrong\u003e\u003cfont size=\"3\"\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\/font\u003e\u003c\/strong\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003e\u003cp\u003ePreface – Pharmacovigilance Medical Writing Comes of Age ix\u003c\/p\u003e \u003cp\u003eAcknowledgements xiii\u003c\/p\u003e \u003cp\u003eAbbreviations xv\u003c\/p\u003e \u003cp\u003e\u003cb\u003e1 Pharmacovigilance Medical Writing – An Overview Across the Drug Development Process 1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003e2 Pharmacovigilance Medical Writing for Clinical Trials 5\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2.1 Introduction 5\u003c\/p\u003e \u003cp\u003e2.2 The EU Annual Safety Report and US IND Annual Report – A Historical Look at Reporting from Clinical Studies 6\u003c\/p\u003e \u003cp\u003e2.3 The Development Safety Update Report 9\u003c\/p\u003e \u003cp\u003e2.4 References 30\u003c\/p\u003e \u003cp\u003e\u003cb\u003e3 Pharmacovigilance Medical Writing for Marketing Authorization 33\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3.1 Introduction 33\u003c\/p\u003e \u003cp\u003e3.2 The Summary of Clinical Safety 34\u003c\/p\u003e \u003cp\u003e3.3 The Integrated Summary of Safety 60\u003c\/p\u003e \u003cp\u003e3.4 The 120-Day Safety Update Report 73\u003c\/p\u003e \u003cp\u003e3.5 References 74\u003c\/p\u003e \u003cp\u003e\u003cb\u003e4 Pharmacovigilance Medical Writing in Risk Evaluation and Management 75\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e4.1 Introduction 75\u003c\/p\u003e \u003cp\u003e4.2 The EU Risk Management Plan 76\u003c\/p\u003e \u003cp\u003e4.3 The Risk Evaluation and Mitigation Strategies Report 96\u003c\/p\u003e \u003cp\u003e4.4 The Benefit-Risk Evaluation Report 106\u003c\/p\u003e \u003cp\u003e4.5 References 114\u003c\/p\u003e \u003cp\u003e\u003cb\u003e5 Pharmacovigilance Medical Writing for Marketed Products 117\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e5.1 Introduction 117\u003c\/p\u003e \u003cp\u003e5.2 The EU Periodic Safety Update Report 119\u003c\/p\u003e \u003cp\u003e5.3 The US Periodic Adverse Drug Experience Report 147\u003c\/p\u003e \u003cp\u003e5.4 The PSUR Addendum Report 157\u003c\/p\u003e \u003cp\u003e5.5 The Summary Bridging Report 163\u003c\/p\u003e \u003cp\u003e5.6 References 169\u003c\/p\u003e \u003cp\u003e\u003cb\u003e6 The Ad-Hoc Safety Review and Response to Questions Document 171\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6.1 Introduction 171\u003c\/p\u003e \u003cp\u003e6.2 The Ad-Hoc Safety Review 172\u003c\/p\u003e \u003cp\u003e6.3 The Response to Questions Document 179\u003c\/p\u003e \u003cp\u003e\u003cb\u003e7 The Rest of the World 185\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e7.1 Introduction 185\u003c\/p\u003e \u003cp\u003e7.2 Japan 186\u003c\/p\u003e \u003cp\u003e7.3 Canada 188\u003c\/p\u003e \u003cp\u003e7.4 Australia and New Zealand 188\u003c\/p\u003e \u003cp\u003e7.5 India 189\u003c\/p\u003e \u003cp\u003e7.6 Singapore and Taiwan 190\u003c\/p\u003e \u003cp\u003e7.7 References 191\u003c\/p\u003e \u003cp\u003eAppendices Appendix 1: Sample Line Listing 193\u003c\/p\u003e \u003cp\u003eAppendix 2: Sample Summary Tabulation 197\u003c\/p\u003e \u003cp\u003eAppendix 3: Another Look at the US IND Annual Report 199\u003c\/p\u003e \u003cp\u003eAppendix 4: The New Pharmacovigilance Legislation in the EU 211\u003c\/p\u003e \u003cp\u003eAppendix 5: The New EU Risk Management Plan 215\u003c\/p\u003e \u003cp\u003eAppendix 6: The New EU Periodic Safety Update Report\/Periodic Benefit-Risk Evaluation Report 227\u003c\/p\u003e \u003cp\u003eGlossary 253\u003c\/p\u003e \u003cp\u003eIndex 259\u003c\/p\u003e\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\u003cp\u003e\u003cfont size=\"3\"\u003eSubject Areas: Other branches of medicine [\u003ca title=\"See our other books on Other branches of medicine\" href=\"https:\/\/freshlyprintedbooks.co.uk\/search?q=%22Other%20branches%20of%20medicine%20%5BMM%5D%22\"\u003eMM\u003c\/a\u003e]\u003c\/font\u003e\u003c\/p\u003e\r\n\r\n\r\n\u003c\/font\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Brand New","offer_id":52173825278232,"sku":"9781119967262","price":38.79,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0730\/2037\/5320\/files\/9781119967262.jpg?v=1781173695","url":"https:\/\/freshlyprintedbooks.co.uk\/products\/pharmacovigilance-medical-writing-a-good-practice-guide-paperback-softback-9781119967262","provider":"Freshly Printed Books","version":"1.0","type":"link"}