, 3 mois). Les autres études duraient minimum 18 mois. 2 études duraient 3 ans (Durrieu, Seule 1 étude sur les 9 sélectionnées ne duraient que quelques mois, 1999.

, Les Entreprises du Médicaments LEEM. Les essais cliniques en 10 questions

T. Kennedy-martin, S. Curtis, D. Faries, S. Robinson, and J. Johnston, A literature review on the representativeness of randomized controlled trial samples and implications for the external validity of trial results, Trials, vol.16, issue.3, 2015.

-. Autorisations, Agence nationale de sécurité du médicament et des produits de santé

, Annual Report on EudraVigilance for the European Parliament, the Council and the Commission, 2016.

L. Hazell and S. Shakir, Under-reporting of adverse drug reactions : a systematic review, Drug Saf, vol.29, issue.5, pp.385-96, 2006.

, Conseil National de l'Ordre des Médecins, vol.326, 2016.

, ANSM. Bulletins des vigilances -ANSM : Agence nationale de sécurité du médicament et des produits de santé, 2016.

D. Sur,

B. S. Bloom, Effects of continuing medical education on improving physician clinical care and patient health: a review of systematic reviews, Int J Technol Assess Health Care, vol.21, issue.3, pp.380-385, 2005.

C. Pagotto, F. Varallo, and P. Mastroianni, Impact of educational interventions on adverse drug events reporting, Int J Technol Assess Health Care, vol.29, issue.4, pp.410-417, 2013.

C. Gonzalez-gonzalez, E. Lopez-gonzalez, M. Herdeiro, and A. Figueiras, Strategies to Improve Adverse Drug Reaction Reporting: A Critical and Systematic Review, Drug Saf. mai, vol.36, issue.5, pp.317-345, 2013.

J. Grange, A general practitioner's one year record of adverse drug reactions

, Therapie. juin, vol.67, issue.3, pp.237-279, 2012.

P. Michel, A. Mosnier, I. Dupie, J. Quenon, and J. Brami, Événements indésirables en médecine générale, enquête nationale en soins primaires, Soins. avr, vol.61, issue.804, pp.20-22, 2016.

, Assurance Maladie. ameli.fr -Activité et prescriptions

J. Lundkvist and B. Jönsson, Pharmacoeconomics of adverse drug reactions, Fundam Clin Pharmacol. juin, vol.18, issue.3, pp.275-80, 2004.

D. Formica, J. Sultana, P. Cutroneo, S. Lucchesi, A. R. Crisafulli et al., The economic burden of preventable adverse drug reactions: a systematic review of observational studies, Expert Opin Drug Saf. 3 juill, vol.17, issue.7, pp.681-95, 2018.

, Commission of the European Communities : Staff Working Document : Impact assesment of PV, 2008.

W. Lenz, A short history of thalidomide embryopathy, Teratology. sept, vol.38, issue.3, pp.203-218, 1988.

, ). veille sanitaire, agences sanitaires, afssa, afsset, afssaps, invs, efs, abm, -Politiques publiques -repères -vie-publique.fr, Veille et évaluation des risques sanitaires, La sécurité sanitaire, 1990.

D. Sur,

, Rapport sur l'application de la loi n° 98-535 du 1er juillet 1998 relative au renforcement de la veille sanitaire et du contrôle de la sécurité sanitaire des produits destinés à l'homme

B. Toussaint, Comment éviter les prochaines affaires Vioxx, 2005.

, Enquête sur le MEDIATOR -IGAS -Inspection générale des affaires sociales

, Arnaud Robinet sur le projet de loi , après engagement de la procédure accélérée, relatif au renforcement de la sécurité sanitaire du médicament et des produits de santé (n°3714, N° 3725 -Rapport de M

D. Sur,

, Répertoire des spécialités pharmaceutiques, ANSM -Accueil

, Annual Report on EudraVigilance for the European Parliament, the Council and the Commission, vol.25, 2018.

. Umc-|-vigibase,

J. Srba, V. Descikova, and J. Vlcek, Adverse drug reactions: analysis of spontaneous reporting system in Europe in 2007-2009, Eur J Clin Pharmacol. juill, vol.68, issue.7, pp.1057-63, 2012.

. Ansm, 29. selincro-PSUSA-00010120-201408-scientific conclusions grounds recommending variation

F. R. Varallo, . Guimarães-s-de, . Op, S. Abjaude, C. Mastroianni-p-de et al., Causes for the underreporting of adverse drug events by health professionals: a systematic review, Rev Esc Enferm USP. août, vol.48, issue.4, pp.739-786, 2014.

E. Lopez-gonzalez, M. T. Herdeiro, and A. Figueiras, Determinants of Under-Reporting of Adverse Drug Reactions, Drug Saf. janv, vol.32, issue.1, pp.19-31, 2009.

, List of All Journals Cited in PubMed®

A. Us-|-cochrane,

T. Matthews, LibGuides: Web of Science platform: Web of Science: Summary of Coverage

, Biomedical research -Embase

D. Sur, ABES : Catalogue Sudoc Public -Catalogue Sudoc public -Sudoc

, Disponible sur

C. Wohlin, Guidelines for snowballing in systematic literature studies and a replication in software engineering, Proceedings of the 18th International Conference on Evaluation and Assessment in Software Engineering -EASE '14

E. London and U. Kingdom, , pp.1-10, 2014.

W. H. Inman, Attitudes to adverse drug reaction reporting, Br J Clin Pharmacol. mai, vol.41, issue.5, pp.434-439, 1996.

A. Liberati, D. G. Altman, J. Tetzlaff, C. Mulrow, P. C. Gøtzsche et al., The PRISMA Statement for Reporting Systematic Reviews and Meta-Analyses of Studies That Evaluate Health Care Interventions: Explanation and Elaboration, PLoS Med. 21 juill, vol.6, issue.7, p.1000100, 2009.

, Niveau de preuve et gradation des recommandations de bonne pratique, HAS

R. Bracchi, J. Houghton, F. J. Woods, S. Thomas, S. A. Smail et al., A distance-learning programme in pharmacovigilance linked to educational credits is associated with improved reporting of suspected adverse drug reactions via the UK yellow card scheme, Br J Clin Pharmacol. août, vol.60, issue.2, pp.221-224, 2005.

J. Jacquot, H. Bagheri, and J. Montastruc, La notification d'effet indésirable au secours de l'ordonnance « non substituable » ! Therapie, juin, vol.69, issue.3, pp.259-61, 2014.

R. Gerritsen, H. Faddegon, F. Dijkers, K. Van-grootheest, and E. Van-puijenbroek, Effectiveness of Pharmacovigilance Training of General Practitioners A Retrospective Cohort Study in the Netherlands Comparing Two Methods, Drug Saf, vol.34, issue.9, pp.755-62, 2011.

X. Humbert, B. Chretien, M. Sassier, A. Coquerel, J. Alexandre et al., Evaluation of a new pharmacovigilance tool: simplified online reporting for general practitioners, Sante Publique (Bucur). avr, vol.30, issue.2, pp.225-257, 2018.

G. Durrieu, J. Jacquot, D. Baudrin, M. Mege, V. Rousseau et al., Apport de la visite d'assistants de recherche clinique aux cabinets de médecins généralistes sur la notification des effets indésirables médicamenteux, Therapie. juin, vol.72, issue.3, pp.351-356, 2017.

J. Sanglier, La déclaration des effets indésirables médicamenteux en médecine générale: étude descriptive sur une période de trois mois évaluant l'intérêt d'une fiche de déclaration simplifiée, 2007.

C. Outters, Un nouvel outil de notification des effets indésirables médicamenteux à destination des médecins généralistes en Midi-Pyrénées: www.mediceo.fr, 2009.

C. Biagi, N. Montanaro, E. Buccellato, G. Roberto, A. Vaccheri et al., Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region), Eur J Clin Pharmacol. févr, vol.69, issue.2, pp.237-281, 2013.

M. Tabali, E. Jeschke, A. Bockelbrink, C. M. Witt, S. N. Willich et al., Educational intervention to improve physician reporting of adverse drug reactions (ADRs) in a primary care setting in complementary and alternative medicine, BMC Public Health. 31 juill, vol.9, p.274, 2009.

M. Bäckström and T. Mjörndal, A small economic inducement to stimulate increased reporting of adverse drug reactions--a way of dealing with an old problem?, Eur J Clin Pharmacol. mai, vol.62, issue.5, pp.381-386, 2006.

M. Johansson, G. Brunlöf, C. Edward, and S. M. Wallerstedt, Effects of e-mails containing ADR information and a current case report on ADR reporting rate and quality of reports, Eur J Clin Pharmacol. mai, vol.65, issue.5, pp.511-515, 2009.
URL : https://hal.archives-ouvertes.fr/hal-00534937

M. Johansson, S. Hägg, and S. Wallerstedt, Impact of information letters on the reporting rate of adverse drug reactions and the quality of the reports: a randomized controlled study, BMC Clin Pharmacol, vol.11, p.14, 2011.

J. Ateudjieu, B. Stoll, G. Nguefack-tsague, C. Tchangou, and B. Genton, Vaccines safety; effect of supervision or SMS on reporting rates of adverse events following immunization (AEFI) with meningitis vaccine (MenAfriVac (TM)): A randomized controlled trial, Vaccine. 29 sept, vol.32, issue.43, pp.5662-5670, 2014.

A. Figueiras, M. T. Herdeiro, J. Polónia, and J. J. Gestal-otero, An educational intervention to improve physician reporting of adverse drug reactions: a clusterrandomized controlled trial, JAMA. 6 sept, vol.296, issue.9, pp.1086-93, 2006.

E. Lopez-gonzalez, M. T. Herdeiro, M. Piñeiro-lamas, and A. Figueiras, Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial, Drug Saf. févr, vol.38, issue.2, pp.189-96, 2015.

S. M. Wallerstedt, G. Brunlöf, M. Johansson, C. Tukukino, and L. Ny, Reporting of adverse drug reactions may be influenced by feedback to the reporting doctor, Eur J Clin Pharmacol. mai, vol.63, issue.5, pp.505-513, 2007.

J. M. Castel, A. Figueras, C. Pedrós, J. Laporte, and D. Capellà, Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including yellow cards in prescription pads, Drug Saf, vol.26, issue.14, pp.1049-55, 2003.

M. T. Herdeiro, I. Ribeiro-vaz, M. Ferreira, J. Polónia, A. Falcão et al., Workshop-and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal, Drug Saf. 1 août, vol.35, issue.8, pp.655-65, 2012.

M. T. Ferreira-herdeiro, Improving adverse drug reaction reporting in portuguese health professional : case-control studies and cluster-randomized trial, 2005.

R. Varallo, F. Vera, Z. Marta, M. De-carvalho-mastroianni, and P. , An approach to increase adverse drug events reports in Mercosur, Afr J Pharm Pharmacol. 8 déc, vol.9, issue.45, pp.1062-70, 2015.

D. Sanghavi, P. Dhande, K. Yogita, S. Sahasrabudhe, R. et al., Impact of series of interventions on clinicians' awareness about pharmacovigilance system in Western India, Asian J Pharm Clin Res. 1 janv, vol.7, pp.14-20, 2014.

M. Alshakka and W. Badulla, Pharmacovigilance: Our experience in Aden, World J Pharm Sci, vol.6, issue.11, pp.57-61, 2018.

K. Santosh, P. Tragulpiankit, P. Gorsanam, I. R. Edwards, and K. Alam, Strengthening the Pharmacovigilance Programme in Nepal, Nepal J Epidemiol. 30 mars, vol.3, issue.1, pp.230-235, 2013.

P. R. Shankar, P. Subish, P. Mishra, and A. K. Dubey, Teaching pharmacovigilance to medical students and doctors, Indian J Pharmacol. 9 janv, vol.38, issue.5, p.316, 2006.

B. Jeudy-brosset, Utilisation d'un module semi-automatique de déclaration des effets indésirables médicamenteux: une proposition pour simplifier la démarche du médecin généraliste, 2014.

B. Ferry, Exploitation systématique de la iatrogénie identifiée en Médecine Générale à des fins de Pharmacovigilance, 2015.

B. Finn and B. C. Carlstedt, Reporting adverse drug reactions in an ambulatory care setting, Am J Health-Syst Pharm AJHP Off J Am Soc Health-Syst Pharm. 1 déc, vol.52, issue.23, pp.2704-2710, 1995.

A. Alharf, N. Alqahtani, G. Saeed, A. Alshahrani, M. Alshahrani et al., Saudi Vigilance Program: Challenges and lessons learned, Saudi Pharm J. 1 mars, vol.26, issue.3, pp.388-95, 2018.

F. Montastruc, H. Bagheri, I. Lacroix, C. Damase-michel, L. Chebane et al., Adverse Drug Reaction Reports Received Through the Mobile App, VigiBIP®: A Comparison with Classical Methods of Reporting, Drug Saf, vol.41, issue.5, pp.511-515, 2018.

V. Stoynova, I. N. Getov, E. K. Naseva, H. V. Lebanova, and E. E. Grigorov, Physicians' knowledge and attitude towards adverse event reporting system and result to intervention--randomized nested trial among Bulgarian physicians, Med Glas Off Publ Med Assoc Zenica-Doboj Cant Bosnia Herzeg. août, vol.10, issue.2, pp.365-72, 2013.

S. U. Dombrowski, P. Campbell, H. Frost, A. Pollock, J. Mclellan et al., Interventions for sustained healthcare professional behaviour change: a protocol for an overview of reviews, vol.5, 2016.

K. Dwan, D. G. Altman, J. A. Arnaiz, J. Bloom, A. Chan et al., Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias, PLoS ONE, vol.3, issue.8, 2008.

D. Sur,

D. Motola, A. Vargiu, R. Leone, A. Conforti, U. Moretti et al., Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy, Drug Saf, vol.31, issue.7, pp.609-625, 2008.

D. Sur,

A. D. Oxman, M. A. Thomson, D. A. Davis, and R. B. Haynes, No magic bullets: a systematic review of 102 trials of interventions to improve professional practice, CMAJ Can Med Assoc J J Assoc Medicale Can, vol.153, issue.10, pp.1423-1454, 1995.

M. Tuccori, G. Giustarini, C. Blandizzi, A. Capogrosso-sansone, M. Rossi et al., Quality of Adverse Drug Reaction (QADRA) reports: an algorithm to appraise the efficiency of spontaneous reporting systems in pharmacovigilance, J Public Health. août, vol.21, issue.4, pp.365-72, 2013.

P. Bhatt and A. Singh, Comparative evaluation of adverse drug reaction reporting forms for introduction of a spontaneous generic ADR form, J Pharmacol Pharmacother, vol.3, issue.3, p.228, 2012.

. Who-u, The Form Of The Form, 2014.

M. Reumerman, J. Tichelaar, B. Piersma, M. C. Richir, and M. A. Van-agtmael, Urgent need to modernize pharmacovigilance education in healthcare curricula: review of the literature, Eur J Clin Pharmacol. oct, vol.74, issue.10, pp.1235-1283, 2018.

T. Schutte, J. Tichelaar, M. O. Reumerman, R. Van-eekeren, L. Rolfes et al., Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study, Drug Saf, vol.40, issue.5, pp.409-427, 2017.

A. Tomlin, D. Reith, S. Dovey, and M. Tilyard, Methods for retrospective detection of drug safety signals and adverse events in electronic general practice records, Drug Saf. 1 sept, vol.35, issue.9, pp.733-776, 2012.

H. Dormann, U. Muth-selbach, S. Krebs, M. Criegee-rieck, I. Tegeder et al., Incidence and Costs of Adverse Drug Reactions During Hospitalisation: Computerised Monitoring Versus Stimulated Spontaneous Reporting, Drug Saf, vol.22, issue.2, pp.161-170, 2000.

J. A. Linder, J. S. Haas, A. Iyer, M. A. Labuzetta, M. Ibara et al., Secondary use of electronic health record data: spontaneous triggered adverse drug event reporting, Pharmacoepidemiol Drug Saf. déc, vol.19, issue.12, pp.1211-1216, 2010.

I. Convertino, S. Ferraro, C. Blandizzi, and M. Tuccori, The usefulness of listening social media for pharmacovigilance purposes: a systematic review, Expert Opin Drug Saf. nov, vol.17, issue.11, pp.1081-93, 2018.

. Who-u, Uppsala Monitoring Centre Annual Report, 2017.