Title: Teaching Pharmacovigilance: the WHO-Isop Core Elements of a Comprehensive Modular

Electronic supplementary material

Title: Teaching Pharmacovigilance: the WHO-ISoP Core Elements of a Comprehensive Modular Curriculum

Extensive list of literature references relating to the chapters (1 to 15) in Table 1 of the article

Drug Safety [ ], Adis International Limited, Springer International Publishing

Authors: Jürgen Beckmann, WHO Expert Advisory Panel on Medicine Safety, Berlin, Germany; Ulrich Hagemann, Senior Pharmacovigilance expert, Berlin, Germany; Priya Bahri, European Medicines Agency, London, UK;Andrew Bate, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, UK; Ian Boyd, Ian Boyd Consulting, Canberra, Australia; Gerald Dal Pan, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA;Brian Edwards, NDA Regulatory Science Ltd,Leatherhead, UK; Ralph Edwards, Uppsala Monitoring Centre, Uppsala, Sweden; Kenneth Hartigan-Go, Food and Drugs Administration, Department of Health, Philippines, Muntinlupa city, Philippines; Marie Lindquist, Uppsala Monitoring Centre, Uppsala, Sweden; John McEwen, Discipline of Pharmacy, University of Canberra, Canberra, Australia; Yola Moride, Faculty of Pharmacy, Université de Montréal,Montreal, Canada; Sten Olsson, Uppsala Monitoring Centre, Uppsala, Sweden; Shanthi Pal, World Health Organization, Safety and Vigilance, Geneva, Switzerland; Rachida Soulaymani Bencheikh, Centre Anti Poison et de Pharmacovigilance du Maroc, Rabat, Morocco; Marco Tuccori, Hospital of Pisa, Tuscan regional centre of Pharmacovigilance, Pisa, Italy; Claudia Vaca Gonzales, Universidad Nacional de Colombia/Pharmacy School, Bogotá, Colombia; Ian Wong, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong, China

Chapter 1: What is and why do we need pharmacovigilance (PV)?

1.01World Health Organization, the Uppsala Centre for International Drug Monitoring. The importance of pharmacovigilance - safety monitoring of medicinal products. Geneva: WHO; 2002.

1.02The Uppsala Monitoring Centre – WHO collaborating centre for international drug monitoring. Viewpoint 1: Watching for safer medicines – issues, controversies and science in the search for safer and more rational use of medicines. Uppsala:the Uppsala Monitoring Centre; 2002.

1.03Edwards IR. Pharmacovigilance. Br J Clin Pharmacol. 2012;73:979-982.

1.04Aronson JK. Adverse drug reactions: history, terminology, classification, causality, frequency,preventability. In:Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 1-120.

1.05Avorn J. The role of therapeutic agents in modern medicine – B: drug risks. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 9-13.

1.06Edwards IR. Adverse drug reactions. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 195-209.

1.07Jones JK, Kingery EE. History of pharmacovigilance. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 11-25.

1.08Britten N.Adverse drug reactions: societal considerations. In:Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012.pp. 573-584.

1.09Gyllensten H, Jönsson A, Rehnberg C, Carlsten A. How are the costs of drug-related morbidity measured?A systematic literature review. Drug Saf. 2012;35:207-219.

1.10Holm G, Snape JR, Murray-Smith R, et al. Implementing ecopharmacovigilance in practice:challenges and potential opportunities. Drug Saf. 2013;36:533-546.

1.11Snodin DJ, Suitters A. Toxicology and adverse drug reactions. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012.pp. 157-214

Chapter 2: Fundamental Clinical Aspects of ADRs

2.01Aronson JK. Adverse drug reactions: history, terminology, classification, causality, frequency,preventability. In:Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 1-120.

2.02Cobert B. Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury: Jones & Bartlett Learning; 2012.

2.03Pirmohamed M. Mechanisms of adverse drug reactions. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 465-487.

2.04Pushpakom SP, Pirmohamed M. Pharmacogenetics of adverse drug reactions. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 121-156.

2.05Evans WE, Relling MV. Moving towards individualized medicine with pharmacogenomics. Nature. 2004;429:464-468.

2.06Craig A.Clinical laboratory safety data. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012.pp. 291-348.

2.07Jaquenoud Sirot E, van der Velden JW, Rentsch K et al. Therapeutic drug monitoring and pharmacogenetic testsas tools in pharmacovigilance. Drug Saf. 2006;29:735-768.

2.08European Medicines Agency.Good pharmacovigilance practices (GVP ). Guidelineonconductofpharmacovigilancefor medicinesusedbythepaediatricpopulation (Rev. 1). 2007. Accessed 31 May 2014.

2.09World Health Organization. Promoting safety of medicines for children. Geneva: WHO; 2007.

2.10Murphy D, Cope J, Iyasu S. Pharmacovigilance in paediatrics. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 625-637.

2.11Coleman JJ. Drugs and the elderly. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 639-657.

2.12Drug Safety – Supplement “Adverse Drug Events in Older Geriatric Patients”. Drug Saf. 2012; 35 Suppl. 1.

2.13Chambers CD, Andrews EB. Special populations – drug safety in pregnancy. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 611-623.

Chapter 3: Important ADRs and ‘Risk Driving’ ADRs of Important Medicines

3.01Aronson JK, editor. Meyler’s side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. 15th ed. Amsterdam: Elsevier; 2006.

3.02Sweetman SC, editor. Martindale – the complete drug reference. 37th ed. London: Pharmaceutical Press; 2013.

3.03World Health Organization. WHO Model Formulary 2008. Geneva: WHO Press; 2009.

3.04Valeyrie-Allanore L, J-C Roujeau. Dermatological adverse drug reactions. In:Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 503-511.

3.05Carey PJ. Haematological adverse drug reactions. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 527-537.

3.06Aithal GP, Larrey D. Hepatic adverse drug reactions. In:Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 539-555.

3.07Abboud G, Kaplowitz N. Drug-induced liver injury. Drug Saf. 2007;30:277-294.

3.08Lee WM. Drug-induced hepatotoxicity. NEngl JMed. 2003;349:474-485.

3.09Verpooten GA. Renal adverse drug reactions. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 567-575.

3.10Lanas Arbeola A, Sostres Homedes C. Gastrointestinal adverse drug reactions. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 513-525.

3.11Ma RCW, Kong APS, Chan N, et al. Drug-induced endocrine and metabolic disorders. Drug Saf.2007;30:215-245.

3.12Djokomoeljanto R, Davis JRE. Endocrine disorders. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 659-682.

3.13Schubert C, Hsia J. The cardiovascular spectrum of adverse drug reactions. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 577-583.

3.14Murphy CA, Dargie HJ. Drug-induced cardiovascular disorders. Drug Saf. 2007;30:783-804.

3.15Walters BB. Neurological adverse events. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 585-609.

3.16Moore N, Bégaud B. Treatment of psychiatric disorders. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 583-593.

3.17Fraunfelder FW. Ocular side effects. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 557-565.

3.18Li J, Tripathi RC, Tripathi BJ. Drug-induced ocular disorders. Drug Saf. 2008;31:127-141.

3.19van Boxtel CJ. Analgesics, antirheumatics and drugs for the treatment of gout. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 387-395.

3.20van Boxtel CJ. Antimicrobial agents. In: Van Boxtel CJ, Edwards IR, Santoso B, editors. Drug benefits and risks – international textbook of clinical pharmacology. 2nded. Amsterdam: IOS Press; 2008. pp. 315-340.

3.21World Health Organization. A practical handbook on the pharmacovigilance of antiretroviral medicines.Geneva: WHO; 2009.

3.22World Health Organization. Pharmacovigilancefor antiretrovirals in resource-poor countries. Geneva: WHO; 2007.

3.23World Health Organization. A practical handbook on the pharmacovigilance of medicines used in the treatmentof tuberculosis - enhancing the safety of the TB patient. Geneva: WHO; 2012.

3.24World Health Organization. A practical handbook on the pharmacovigilance of antimalarial medicines. Geneva: WHO;2008.

3.25CIOMS, World Health Organization. Definition and application of terms for vaccine pharmacovigilance. Geneva: WHO;2012.

3.26Woo EJ, Labadie J, Braun MM. Vaccine safety surveillance. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 305-317.

3.27Labadie J. Vaccine safety. Int J Risk Saf Med. 2011;23:113-115.

3.28Miller E, Stowe J. Vaccine safety surveillance. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012.pp. 603-624.

3.29Erdman A, Nickas J, Brown B. Safety of biotherapeutics. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 585-602.

3.30World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva: WHO; 2004.

3.31Barnes J. Adverse drug reactions and pharmacovigilance of herbal medicines. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012.pp. 645-684.

3.32Centre for Tropical Clinical Pharmacology and Therapeutics – University of Ghana Medical School. PV Toolkit. Accessed 31 May 2014.

3.33Saokaew S, Suwankesawong W, Permsuwan U, Chaiykunapruk N. Safety of herbal products in Thailand.Drug Saf. 2011;34:339-350.

Chapter 4: “Individual Case Safety Reports” (ICSRs)

4.01Aronson JK. Adverse drug reactions: history, terminology, classification, causality, frequency,preventability. In:Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 1-120.

4.02Aronson JK. Case reports as evidence in pharmacovigilance. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014. pp. 121-137.

4.03CIOMS. Reporting adverse drug reactions: definitions of terms and criteria for their use. Geneva: WHO; 1999.

4.04CIOMS form: Suspect adverse reaction report. Accessed 31 May 2014.

4.05ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for expedited reporting.E2A. 1995. Accessed 31 May 2014.

4.06ICH harmonised tripartite guideline.Post-approval safety data management: definitions and standards for expedited reporting.E2D. 2003. Accessed 31 May 2014.

4.07Cobert B. Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury: Jones & Bartlett Learning; 2012.

4.08Medicines and Health products Regulatory Authority. Good pharmacovigilance practice guide. London: Pharmaceutical Press; 2009.

4.09Strutt KL, Arnold BDC. Regulatory aspects of pharmacovigilance. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell;. pp. 411-510.

4.10Banerjee AK, Okun S, Edwards IR, et al. Patient-Reported Outcome measures in Safety Event Reporting: PROSPER consortium guidance. Drug Saf. 2013;36:1129-1149.

4.11Bergvall T, Norén N, Lindquist M. VigiGrade: a tool to identify well-documented individual case reportsand highlight systematic data quality issues. Drug Saf. 2014;37:65-77.

4.12The Uppsala Monitoring Centre. The use of the WHO-UMC systemfor standardised case causality assessment.Uppsala: the Uppsala Monitoring Centre; 2013. Accessed 31 May 2014.

4.13World Health Organization. Causality assessment of an adverse event following immunization (AEFI). Usermanual for the revised WHOclassification. Geneva:WHO; 2013. Accessed 31 May 2014.

4.14Jones J, Kingery E. How we assess causality. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 319-329.

4.15Klepper MJ, Edwards B. Individual case safety reports – how to determine the onset dateof an adverse reaction - a survey. Drug Saf. 2011;34:299-305.

4.16Kelly WN, Arellano FM, Barnes J, et al. Guidelines for submitting adverse event reportsfor publication. Drug Saf. 2007;30:367-373.

Chapter 5: Pharmacovigilance in Clinical Trials

5.01CIOMS. Management of safety information from clinical trials: report of CIOMS Working Group VI. Geneva: WHO; 2005.

5.02ICHharmonised tripartite guideline: development safety update report. E2F. 2010. Accessed 31 May 2014.

5.03FDA Guidance for Industry. Premarketing risk assessment. March 2005.

5.04European Commission. Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use. 2006. Accessed 31 May 2014.

5.05Talbot J, Keisu M, Ståhle L. Clinical trials – collecting safety data and establishing the adverse drug reactions profile. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell;pp. 215-290.

5.06Berlin JA, Crowe B, Xia A. The evaluation of adverse events in clinical trials (with a particular focus on the use of meta analysis). In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester; Wiley-Blackwell; 2014. pp. 109-119.

5.07Cobert B. Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury: Jones & Bartlett Learning; 2012.

5.08Medicines and Health products Regulatory Authority. Good pharmacovigilance practice guide. London: Pharmaceutical Press; 2009.

5.09Banerjee AK, Okun S, Edwards RI, et al. Patient-Reported Outcome measuresin Safety Event Reporting:ROSPER consortium guidance. Drug Saf. 2013;36:1129-1149.

Chapter 6: Counterfeiting, Quality Defects and Medication Errors

6.01World Health Organization.General information on counterfeit medicines. Accessed 31 May 2014.

6.02World Health Organization, Department of Essential Drugs and Other Medicines. Guidelines for the development of measures to combat counterfeit drugs. Geneva: WHO; 1999.

6.03International Medical ProductsAnti-Counterfeiting Taskforce (IMPACT). Documentsdeveloped by the Assembly and the Working Groups2006-2010. Agenzia Italiana del Farmaco. 31 May 2014.

6.04World Health Organization, IMPACT. Counterfeit drugs can kill.Geneva: WHO; 2008. Accessed 31 May 2014.

6.05World Health Organization. Current Topics: Mechanism to combatsubstandard/spurious/falselylabelled/falsified/counterfeitmedical products. WHO Drug Inf. 2013;27, No. 1. Accessed 31 May 2014.

6.06World Health Organization.Quality and Safety of Medicines. WHO Drug Inf. 2013;27, No. 2. Accessed 31 May 2014.

6.07Labadie J. Forensic pharmacovigilance and substandard or counterfeit drugs. Int J Risk Safety Med. 2012;24:37-39.

6.08Medicines and Health products Regulatory Authority. Good pharmacovigilance practice guide. London: Pharmaceutical Press; 2009.

6.09Ferner RE, Aronson JK. Clarification of terminology in medication errors –definitions and classification. Drug Saf. 2006;29:1011-1022.

6.10Kohn LT, Corrigan JM, Donaldson MS. To err is human: building a safer health system. Washington DC: Natl Acad Press; 2000.

6.11Hartigan-Go K. Medication errors. Uppsala Reports. 2006;33:16-18.

6.12Wong ICK, Ghaleb MA, Franklin BD, Barber N. Incidence and nature of dosing errors in paediatric medications. Drug Saf. 2004;27:661-670.

6.13Temple ME, Robinson RF, Miller JC, et al. Frequency and preventability of adverse drug reactions in paediatricpatients. Drug Saf. 2004;27:819-829.

6.14American Geriatrics Society updated Beers criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2012;(Special Articles):1-16. Accessed 31 May 2014.

6.15Keers RN, Williams SD, Cooke J, Ashcroft DM. Causes of medication errors in hospitals:a systematic review of quantitative and qualitative experience. Drug Saf. 2013;36:1045-1067.

6.16Krähenbühl-Melcher A, Schlienger R, Lampert M, et al. Drug-related problems in hospitals. Drug Saf. 2007;30:379-407.

6.17Ferner RE, Aronson JK. Preventability of drug-related harms – part I. Systematic review. Drug Saf. 2010;33:985-994.

6.18US Department of Health and Human Services.Medication management guideline. Accessed 31 May 2014.

6.19Edwards IR. The WHO World Alliance for Patient Safety – a new challenge or an old one neglected? Drug Saf. 2005;28:379-386.

Chapter 7: Spontaneous ICSR Reporting Systems (SRS)

7.01Aronson JK. Adverse drug reactions: history, terminology, classification, causality, frequency,preventability. In:Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 1-120.

7.02The Uppsala Monitoring Centre – WHO collaborating centre for international drug monitoring. Viewpoint 2: Watching for safer medicines; the scientific and technical story - international collaboration, research and resources for the safer and more rational use of medicines.Uppsala: The Uppsala Monitoring Centre; 2004.

7.03ICH harmonised tripartite guideline. Clinical safety data management: definitions and standards for expedited reporting.E2A. 1995. Accessed 31 May 2014.

7.04ICH guideline E2B (R3) on electronic transmission of individual case safety reports (ICSRs): data elements and message specification - implementation guide. 2013. 31 May 2014.

7.05ICH harmonised tripartite guideline.Post-approval safety data management: definitions and standards for expedited reporting.E2D. 2003. Accessed 31 May 2014.

7.06WHO Drug Dictionary Enhanced (WHO DDE). Accessed 31 May 2014.

7.07Brown E, von Sydow D. Terminologies in pharmacovigilance. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 77-93.

7.08Brown EG, Harrison JE. Dictionaries and coding in pharmacovigilance. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 545-572.

7.09Cobert B. Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury: Jones & Bartlett Learning; 2012.

7.10Medicines and Health products Regulatory Authority. Good pharmacovigilance practice guide. London: Pharmaceutical Press; 2009.

7.11Medicines and Health products Regulatory Authority. Best practice in reporting of individual case safety reports (ICSRs). 2011. Accessed 31 May 2014.

7.12World Health Organization. WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems. Geneva: WHO; 2004.

7.13World Health Organization. Safety monitoring of medicinal products – reporting system for the general public. Geneva: WHO; 2012.

7.14Banerjee AK, Okun S, Edwards IR, et al. Patient-Reported Outcome measuresin Safety Event Reporting: PROSPER consortium guidance. Drug Saf. 2013;36:1129-1149.

7.15Van Hunsel F, Härmark L, Pal S,et al. Experiences with adverse drug reaction reporting by patients – an 11-country survey. Drug Saf. 2012;35:45-60.

7.16Lopez-Gonzales E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32:19-31.

7.17Gonzalez-Gonzalez C, Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Strategies to improve adverse drug reaction reporting: a critical and systematic review. Drug Saf. 2013;36:317-328.

7.18Oosterhuis I, van Hunsel FP, van Puijenbroek EP. Expectations for feedback in adverse drug reporting by healthcare professionals in the Netherlands. Drug Saf. 2012;35:221-232.

7.19Lindquist M. Data quality management in pharmacovigilance. Drug Saf. 2004;27:857-870.

7.20Bergvall T, Norén N, Lindquist M. VigiGrade: a tool to identify well-documented individual case reportsand highlight systematic data quality issues. Drug Saf. 2014;37:65-77.

7.21Lindquist M. VigiBase, the WHO global ICSR database system: basic facts. Drug Inf J. 2007;42:409-919

7.22The Uppsala Monitoring Centre database “vigiBase”.

7.23EudraVigilance human database.

7.24FDA Adverse Event Reporting System (FAERS).

Chapter 8: Signal Detection and Management

8.01CIOMS Working Group VIII - application of signal detection in pharmacovigilance. Geneva:WHO; 2010.

8.02The Uppsala Monitoring Centre – WHO collaborating centre for international drug monitoring. Viewpoint 2: Watching for safer medicines; the scientific and technical story - international collaboration, research and resources for the safer and more rational use of medicines.Uppsala: The Uppsala Monitoring Centre; 2004.

8.03Abou Chakra CN, Pariente A, Pinet M, et al.. Case series in drug safety. Drug Saf. 2010;33:1081-1088.

8.04Evans SJW, Nitsch D. Statistics - analysis and presentation of safety data. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 349-388.

8.05Bate A, Pariente A, Hauben M, Bégaud B. Quantitative signal detection and analysis in pharmacovigilance. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 331-353.

8.06Cobert B. Cobert’s manual of drug safety and pharmacovigilance. 2nd ed. Sudbury: Jones & Bartlett Learning; 2012.

8.07Medicines and Health products Regulatory Authority. Good pharmacovigilance practice guide. London: Pharmaceutical Press; 2009.

8.08Evans SJ, Bate A. Quantitative signal detection using spontaneous ADR reporting.Pharmacoepidemiol Drug Saf. 2009;8:427-436.

8.09Brown JS, Petronis KR, Bate A, et al. Drug adverse event detection in health plan data using the gamma Poisson shrinker and comparison to the tree-based scan statistic. Pharmaceutics. 2013;5:179-200.

8.10Hopstadius J, Norén GN, Bate A, Edwards IR. Impact of stratification on adverse drug reaction surveillance. Drug Saf. 2008;31:1035-1048.

Chapter 9: Post-Authorisation Observational Studies and Clinical Trials in PV

9.01Strom BL, Kimmel SE, Hennessy S, editors. Pharmacoepidemiology. 5th ed. Chichester: Wiley-Blackwell; 2012.

9.02Evans SJW, Nitsch D. Statistics - analysis and presentation of safety data. In: Talbot J, Aronson JK, editors. Stephens’ detection and evaluation of adverse drug reactions – principles and practice. 6th ed. Chichester: Wiley-Blackwell; 2012. pp. 349-388.

9.03International Society for Pharmacoepidemiology (ISPE). Guidelines for good pharmacoepidemiology practices (GPP). PharmacoepidemiolDrug Saf. 2008;17:200–208. Accessed 31 May 2014.

9.04Goedecke T, Arlett P. A description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a global resource for pharmacovigilance and pharmacoepidemiology. In: Andrews E, Moore N, editors. Mann’s Pharmacovigilance. 3rd ed. Chichester: Wiley-Blackwell; 2014.pp. 403-407.