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Pharmacovigilance 2nd Edition Textbook Now Available
Drs. Ronald D. Mann and Elizabeth B. Andrews, Editors/Authors
posted 2007.2.7

Drs. Ronald D. Mann and Elizabeth B. Andrews, Editors/Authors

Co-edited and co-authored by University of Southampton’s Dr. Ronald Mann and RTI Health Solutions’ Dr. Elizabeth Andrews, the second edition of Pharmacovigilance is now available. Since publication of the first edition of Pharmacovigilance, relevant concepts have moved forward very rapidly with the publication by the EMEA of a guidance on risk management, and the publication of three guidance documents by the FDA relating to good pharmacovigilance and pharmacoepidemiology practices, premarketing risk assessment, and the development and use of risk minimization action plans (RiskMAPs).  These rapid strides forward have required a new edition of Pharmacovigilance, for the subject remains an area of ever-increasing research endeavor and activity.

Mann and Andrews have built on the success of the first edition by expanding the content to include reporting in Germany and Japan, plus a wider range of organ classes and current topics. Otherwise the book retains its structure and purpose – to be a comprehensive volume on the whole area of Pharmacovigilance.

More information is available on the publisher’s website. Pre-orders are now being accepted and first deliveries are expected for March 2007.

Pharmacovigilance, 2nd Edition Table of Contents:


1.   Introduction (Ronald D. Mann and Elizabeth B. Andrews)
2.   Legal Basis – EU (Nicholas Macfarlane, Paul Brown, Caroline Moore, Claire Taylor,Uwe Froehlich, Tanja Barton, Olivier Banchereau and Paola La Licata)
3.   Legal Basis – United States (Jayne P. Bultena)
4.   Ethical Oversight, Consent and Confidentiality (Donna A. Boswell and Elizabeth B. Andrews)
5.   Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation (Priya Bahri and Panos Tsintis)
6.   Periodic Safety Update Reports (Patrice Verpillat and Mondher Toumi)
7.   Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials (Patricia M. Reed, Stuart J. Mair and Stephen Freestone)
8.   Mechanisms of Adverse Drug Reactions (Munir Pirmohamed and B. Kevin Park)
9.   Micturin and Torsades de Pointes (Richard N. Wild)
10.   Withdrawal of Terodiline: A Tale of Two Toxicities (Rashmi R. Shah)
11.   Nomifensine and Haemolytic Anaemia (Peter D. Stonier and J. Guy Edwards)


12.   WHO Programme – Global Monitoring ( I. Ralph Edwards and Cecilia Biriell)
13.   Medical Dictionary for Regulatory Activities (MedDRA®) (Elliot Brown)
14.   Regulatory Pharmacovigilance in the EU (Priya Bahri, Panos Tsintis and Patrick C. Waller)
15.   Spontaneous Reporting – UK (Sarah Davis, Bridget King and June M. Raine)
16.   Spontaneous Reporting – France (Nicholas Moore, Carmen Kreft-Jais and Alban Dhanani)
17.   Spontaneous Reporting in Germany (Ulrich Hagemann and Norbert Paeschke)
18.   Spontaneous Reporting – United States (David J. Graham, Syed R. Ahmad and Toni Piazza-Hepp)
19.   Statistical Methods of Signal Detection (Stephen Evans)
20.   Statistical Methods of Evaluating Pharmacovigilance Data (Bernard Bégaud)
21.   Data Mining in Pharmacovigilance: A View from the Uppsala Monitoring Centre ( I. Ralph Edwards, Marie Lindquist, Andrew Bate and G. Niklas Norén)
22.   Pharmacovigilance in the Netherlands (Kees van Grootheest and Eugene van Puijenbroek)
23.   CIOMS Working Groups and their Contribution to Pharmacovigilance (Sue Roden and Trevor Gibbs)
24.   PEM in the UK (Saad A.W. Shakir)
25.   PEM in New Zealand (Mira Harrison-Woolrych and David M. Coulter)
26.   MEMO in the United Kingdom (Douglas Steinke, Josie M.M. Evans and Thomas M. Macdonald)
27.   The General Practice Research Database: Now and the Future (John Parkinson, Sarah Davis and Tjeerd Van Staa)
28.   Overview of North American Databases (Brian L. Strom and Judith L. Kinman)
29.   Other Databases in Europe for the Analytic Evaluation of Drug Effects (Miriam C.J.M. Sturkenboom)
30.   Surveillance for Medical Devices – USA (Thomas P. Gross)
31.   Pharmacovigilance and Risk Management in Japan (Kiyoshi Kubota and Hiroko Koyama)


32.   Dermatological ADRs (Laurence Allanore-Valeyrie and Jean-Claude Roujeau)
33.   Gastrointestinal ADRs (John R. Wood and Graham A. Pipkin)
34.   Haematological ADRs (Peter J. Carey)
35.   Hepatic ADRs (Guruprasad P. Aithal and Christopher P. Day)
36.   Ocular Side Effects of Prescription Medications (F.W. Fraunfelder)
37.   Drug Safety in Pregnancy (Christina D. Chambers and Elizabeth B. Andrews)
38.   Renal Adverse Drug Reactions (Gert A. Verpooten)
39.   Anaesthetic Adverse Drug Reactions (Anita Holdcroft)
40.   Pharmacovigilance in Pediatrics (Solomon Iyasu and M. Dianne Murphy)
41.   The Cardiovascular Spectrum of Adverse Drug Reactions (Judith Hsia, Jinping Mo, Laura Burleson and Annlouise R. Assaf)
42.   Drugs and the Elderly (Una Martin and Jamie J. Coleman)


43.   US Activities in Risk Management of Pharmaceutical Products (Jonca Bull)
44.   Risk Management – a European Regulatory View (June M. Raine)
45.   The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents (Julie Magno Zito and Daniel J. Safer)
46.   Pharmacoepidemiology of Hormone Therapy: An Evolving Picture (Annlouise R. Assaf, Laura E. Burleson and Joann E. Manson)
47.   NSAIDs – COX-2 Inhibitors – Risks and Benefits (K. Arnold Chan and S. Christopher Jones)
48.   Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences (John Urquhart and Bernard Vrijens)


49.   Teaching and Learning Pharmacovigilance (Frank May)
49b.   Practical Experience in Teaching Pharmacovigilance (Stephen Evans)
50.   Fatal Medication Errors and Adverse Drug Reactions – Coroners’ Inquests and Other Sources (R.E. Ferner, S.E. McDowell and A.K. Cotter)
51.   Pharmacogenetics and the Genetic Basis of ADRs (Penelope K. Manasco)
52.   Keynote Clinical Lessons from Pharmacovigilance (David H. Lawson and Keith Beard)


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