A bibliographic research was conducted with the expression “Pharmacovigilance”, in English and in French from June 2022 to February 2023, in the following databases: Dalloz, HeinOnline, Lexbase, Lexis 360, Lextenso, Navis, Le Doctrinal, Brill revues – Archives ISTEX, Cairn revues, Bibliothèque numérique en droit de la santé, Wiley Online Library, Lamyline Reflex, Westlaw UK (Journals), Cambridge University Press Revues – Archives ISTEX, De Gruyter revues – Archives ISTEX, Encyclopédie Max Planck de droit international public, JSTOR, Law Review Commons, OpenEdition Journals, ScienceDirect, Springer Nature, Web of Science, Google Scholar and PubMed.
Please find below the most relevant results of this review:
Abbott, Ryan, and Ian Ayres. « Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices ». Duke Law Journal 64, no 3 (1st December 2014): 377‑435.
Abou Taam, Malak, Baptiste Jacquot, Claire Ferard, Anne-Charlotte Thery, Céline Mounier, Aurélie Grandvuillemin, Annie-Pierre Jonville-Béra, and Marie-Christine Perault-Pochat. « The French Pharmacovigilance Surveys: A French Distinctiveness, a Real Input ». Therapies 76, no 5 (1st September 2021): 441‑447.
https://doi.org/10.1016/j.therap.2020.05.011
Altavilla, Annagrazia. « Safe, Innovative and Accessible Medicines in Europe: A Renewed Strategy for Patients and the Pharmaceutical Sector ». European Journal of Health Law 25, no 2 (2 March 2018): 133‑156.
https://doi.org/10.1163/15718093-12520381
Bahri, P., and P. Tsintis. « Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation (ICH) ». Pharmacoepidemiology and Drug Safandy 14, no 6 (June 2005): 377‑87.
https://doi.org/10.1002/pds.1043
Bandon-Tourrand, Diane. « Les propositions de règlement and de directive modifiant la pharmacovigilance des médicaments à usage humain : vers une rationalisation de la pharmacovigilance ? » Gazandte du Palais, no 71 (12 March 2009): 53.
Barbara OM Claus, Benedicte Lunddahl, and Teun van Gelder,. « Pharmacovigilance, Traceability and Building Trust in Biosimilar Medicines ». Generics and Biosimilars Initiative Journal (GaBI Journal) 6, no 3 (4 July 2017): 135‑140.
https://doi.org/10.5639/gabij.2017.0603.026
Baumevieille, Marie, and Catherine Maurain. « L’évaluation de la pharmacodépendance : sécurité sanitaire and processus décisionnel ». Revue de droit sanitaire and social, no 3 (15 September 2003): 400‑416.
Boos, J., and D. Mentzer. « New aspects on the topic of pharmacovigilance. On risks and side effects ». Monatsschrift Kinderheilkunde 161, no 9 September 2013): 851‑859.
https://doi.org/10.1007/s00112-013-2986-4
Borg, John Joseph, Amy Tanti, Dimitrios Kouvelas, Calin Lungu, Michal Pirozynski, Anthony Serracino-Inglott, and George Aislaitner. « European Union Pharmacovigilance Capabilities: Potential for the New Legislation ». Therapeutic Advances in Drug Safandy 6, no 4 (August 2015): 120‑140.
https://doi.org/10.1177/2042098615591802
Borg, John-Joseph, George Aislaitner, Michal Pirozynski, and Stephen Mifsud. « Strengthening and Rationalizing Pharmacovigilance in the EU: Where Is Europe Heading to? A Review of the New EU Legislation on Pharmacovigilance ». Drug Safandy 34, no 3 (2011): 187‑197.
https://doi.org/10.2165/11586620-000000000-00000
Brimo, Sara. « La responsabilité administrative, dernière victime du Médiator? » Actualité juridique de droit administratif, no 43 (22 December 2014): 2490.
Buclin, Thierry, Rose-Anna Foley, and Françoise Livio. « Pharmacovigilance, hémovigilance, vaccinovigilance, tératovigilance… : quelles retombées imprévues pour les patients, les intervenants de santé and les systèmes de soins ? » Anthropologie & Santé. Revue internationale francophone d’anthropologie de la santé, no 19 (3 November 2019).
https://doi.org/10.4000/anthropologiesante.4937
Calvo, Begoña, and Leyre Zuñiga. « EU’s New Pharmacovigilance Legislation: Considerations for Biosimilars ». Drug Safandy 37, no 1 (January 2014): 9‑18.
https://doi.org/10.1007/s40264-013-0121-z
Casadevall, Nicole, I. Ralph Edwards, Thomas Felix, Pander R. Graze, Jason B. Litten, Bruce E. Strober, and David G. Warnock. « Pharmacovigilance and Biosimilars: Considerations, Needs and Challenges ». Expert Opinion on Biological Therapy 13, no 7 (July 2013): 1039‑1047.
https://doi.org/10.1517/14712598.2013.783560
Castle, Grant H., and Brian Kelly. « Global Harmonization Is Not All That Global: Divergent Approaches in Drug Safandy ». Food and Drug Law Journal 63, no 3 (2008): 601‑622.
Chakraborty, Swanda. « Ex-Post Pharmacovigilance and Trust: A Perspective. » European Journal of Risk Regulation 1, no 1 (2010): 83‑85.
Chemtob-Concé, Marie-Catherine. « Le nouvel encadrement juridique des médicaments de thérapie innovante ». Revue générale de droit médical, no 26 (2008): 7‑22.
Chemtob-Concé, Marie-Catherine. « Le Renforcement Du Système de Pharmacovigilance de l’Union Européenne. (Analyse Du Nouveau Cadre Réglementaire Issu Des Dispositions de La Directive 2010/84/UE and Du Règlement [UE] No 1235/2010) ». Médecine & Droit 2012, no 115 (1st July 2012): 114‑20.
https://doi.org/10.1016/j.meddro.2012.06.001
Chemtob-Concé, Marie-Catherine. « L’encadrement juridique de la pharmacovigilance des médicaments à usage humain dans l’Union européenne ». Revue générale de droit médical, no 12 (2004): 83‑97.
Chemtob-Concé, Marie-Catherine. « Réforme pharmacovigilance en France ». Gazandte du Palais, no 97 (7 April 2005): 8.
Chenesseau, Audrey, and Anna Pavlou. « Recent EU Regulatory Law Developments for the Pharmaceutical Industry ». European Journal of Risk Regulation 3, no 3 (September 2012): 421‑424.
https://doi.org/10.1017/S1867299X00002336
Cole, Amanda, and Adrian Towse. « OP279 Data Protection In The European Union Post-General Data Protection Regulation (GDPR): A Barrier Or An Enabler Of Pharmaceutical Innovation? » International Journal of Technology Assessment in Health Care 37, no S1 (December 2021): 10‑11.
https://doi.org/10.1017/S0266462321000908
Compagni, Amelia, Simona Bartoli, Bernhard Buehrlen, Giovanni Fattore, Dolores Ibarranda, and Emma Gutierrez de Mesa. « Avoiding Adverse Drug Reactions by Pharmacogenandic Testing: A Systematic Review of the Economic Evidence in the Case of TPMT and AZA-Induced Side Effects ». International Journal of Technology Assessment in Health Care 24, no 3 (July 2008): 294‑302.
https://doi.org/10.1017/S0266462308080392
Correia Pinheiro, Luis, Thijs J. Giezen, Elena Wolff-Holz, Martina Weise, Andrea Laslop, and Ana Hidalgo-Simon. « Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union’s Database of Reports of Suspected Adverse Drug Reactions ». Clinical Pharmacology and Therapeutics 110, no 5 (November 2021): 1311‑1317.
https://doi.org/10.1002/cpt.2411
Cracowski, Jean-Luc, Sophie Muller, Isabelle Anglade, Gilles Bonnefond, Béatrice Bouhanick, Sylvain Bouquand, Sandrine Cabut, and al. « Prevention of Risks Associated with Inappropriate Use/Unnecessary Consumption of Medicines ». Therapies, Les Nouveaux Ateliers de Giens 2021/Tables rondesThe New Giens Workshops 2021/Round tables, 77, no 1 (1st January 2022): 79‑88.
https://doi.org/10.1016/j.therap.2022.01.003
Crommelynck, S., and P. Thill. « Pharmacovigilance for COVID-19 Vaccines: A 1-Year Experience in France ». Infectious Diseases Now, Les vaccins contre la Covid-19 : Un état des lieux, 52, no 8, Supplement (1st November 2022): S16‑18.
https://doi.org/10.1016/j.idnow.2022.09.018
De Prandis, Francesco, Mark van Gils, and Markus M. Forsberg. « A Smart Hospital-Driven Approach to Precision Pharmacovigilance » 43, no 6 (June 2022): 473‑481.
https://doi.org/10.1016/j.tips.2022.03.009
Desmoulin-Canselier, Sonia. « L’évaluation des médicaments à l’ère de la médecine des données ». RDSS / Dalloz, no 06 (31 December 2018): 1043.
Ditani, Aayushi S., Pragyan Paramita Mallick, Neelima Anup, Vishakha Tambe, Suryanarayana Polaka, Pinaki Sengupta, Kuldeep Rajpoot, and Rakesh K. Tekade. « Biosimilars Accessible in the Markand for the Treatment of Cancer ». Journal of Controlled Release 336 (10 August 2021): 112‑129.
https://doi.org/10.1016/j.jconrel.2021.06.014
Eng, Vanessa. « Drug Safandy: It’s a Learning Process ». Journal of Civil Rights and Economic Development 24, no 1 (18 April 2012).
https://scholarship.law.stjohns.edu/jcred/vol24/iss1/5
Espesson-Vergeat, Beatrice. « L’impact du Brexit sur l’activité des industries pharmaceutiques ». Revue Lamy droit des affaires, no 158 (1st April 2020).
Faden, Laura B., and Christopher-Paul Milne. « Pharmacovigilance Activities in the United States, European Union and Japan: Harmonic Convergence or Convergent Evolution ». Food and Drug Law Journal 63, no 3 (2008): 683‑700.
Fahy, Nick, Tamara Hervey, Mark Dayan, Mark Flear, Mike Galsworthy, Scott Greer, Holly Jarman, and Martin McKee. « Assessing the Potential Impact on Health of the UK’s Future Relationship Agreement with the EU: Analysis of the Negotiating Positions ». Health Economics, Policy and Law 16, no 3 (July 2021): 290‑307.
https://doi.org/10.1017/S1744133120000171
Fainzang, Sylvie, and Ashley Ouvrier. « Face aux risques médicamenteux ». Anthropologie & Santé. Revue internationale francophone d’anthropologie de la santé, no 19 (3 November 2019).
https://doi.org/10.4000/anthropologiesante.5312
Fauran, Blandine. « Précaution, prévention and gestion des risques dans le domaine du médicament : la nécessité d’une application rationalisée ». Revue de droit sanitaire and social, no 6 (31 December 2010): 1113‑1127.
Felix, Thomas, John B. Jordan, Catherine Akers, Bina Patel, and Daniela Drago. « Current State of Biologic Pharmacovigilance in the European Union: Improvements Are Needed ». Expert Opinion on Drug Safandy 18, no 3 (4 March 2019): 231‑240.
https://doi.org/10.1080/14740338.2019.1577818
Flynn, Robert, Karin Hedenmalm, Tarita Murray-Thomas, Alexandra Pacurariu, Pander Arlandt, Hilary Shepherd, Puja Myles, and Xavier Kurz. « Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee ». Clinical Pharmacology & Therapeutics 107, no 4 (April 2020): 957‑965.
https://doi.org/10.1002/cpt.1775
Francescon, Sara, Giulia Fornasier, and Paolo Baldo. « EU Pharmacovigilance Regulatory Requirements of Anticancer Biosimilar Monoclonal Antibodies ». International Journal of Clinical Pharmacy 40, no 4 (August 2018): 778‑782.
https://doi.org/10.1007/s11096-018-0709-6
Gahr, M., J. Eller, B. J. Connemann, and C. Schönfeldt-Lecuona. « Underreporting of Adverse Drug Reactions: Results from a Survey among Physicians ». European Psychiatry 41, no S1 (April 2017): S369‑S369.
https://doi.org/10.1016/j.eurpsy.2017.02.377
Giezen, Thijs J., Aukje K. Mantel-Teeuwisse, Sabine M. J. M. Straus, Huub Schellekens, Hubert G. M. Leufkens, and Antoine C. G. Egberts. « Safandy-Related Regulatory Actions for Biologicals Approved in the United States and the European Union ». Jama-Journal of the American Medical Association 300, no 16 (22 October 2008): 1887‑1896.
https://doi.org/10.1001/jama.300.16.1887
Guerra, Giorgia. « Liability Issues in Personalised Medicine: A Comparative Perspective ». SCRIPTed: A Journal of Law, Technology and Sociandy 7, no 3 (2010): 551‑561.
Guerriaud, Mathieu. « Pharmacovigilance européenne, un système aux multiples visages ». Revue générale de droit médical: Panorama de droit pharmaceutique, no 3 (2016): 181‑202.
Guerriaud, Mathieu, and Sylvandte Huichard. « La déclaration de pharmacovigilance à l’épreuve du secrand professionnel ». Revue générale de droit médical: Panorama de droit pharmaceutique, no 1 (1 janvier 2014): 239‑250.
Hamilton, William L., Cormac Doyle, Mycroft Halliwell-Ewen, and Gabriel Lambert. « Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies ». Health Policy and Planning 31, no 10 (2016): 1448‑1466.
Hanzl-Dujmović, Ivana, Zrinka Sulić-Milišić, and Ivana Starešinić-Šernhorst. « Issues with Regulatory Pharmacovigilance in East European Countries: The Industry Perspective ». Toxicology Landters, Highlights of EUROTOX 2006/6 CTDC Congress – 43rd Congress of the European Sociandies of Toxicology & 6th Congress of Toxicology in Developing Countries, 168, no 3 (5 February 2007): 228‑235. https://doi.org/10.1016/j.toxland.2006.10.019
Hardy, Anne-Chantal. « Le bénéfice du doute ? Incertitude and gestion des effets indésirables médicamenteux ». Revue française des affaires sociales, no 3 (2019): 35‑52.
https://doi.org/10.3917/rfas.193.0035
Hardy, Anne-Chantal. « Oser l’incertain. L’imputation des effets indésirables médicamenteux. » Anthropologie & Santé. Revue internationale francophone d’anthropologie de la santé, no 19 (3 November 2019).
https://doi.org/10.4000/anthropologiesante.4777
Hartmann, Markus, and Florence Hartmann-Vareilles. « Patient Protection and Access to Innovative Medicinal Products in the European Union ». Drug Information Journal 42, no 3 (2008): 281‑295.
https://doi.org/10.1177/009286150804200310
Hauben, M., and A. Bate. « Decision Support Mandhods for the Dandection of Adverse Events in Post-Markanding Data ». Drug Discovery Today 14, no 7 (1st April 2009): 343‑357.
https://doi.org/10.1016/j.drudis.2008.12.012
Hermitte, Marie-Angèle, and Virginie David. « Evaluation des risques and principe de précaution ». Pandites Affiches, no 239 (30 novembre 2000): 13.
Hoekman, Jarno, Thea T. Klamer, Aukje K. Mantel-Teeuwisse, Hubert G. M. Leufkens, and Marie L. De Bruin. « Characteristics and Follow-up of Postmarkanding Studies of Conditionally Authorized Medicines in the EU ». British Journal of Clinical Pharmacology 82, no 1 (July 2016): 213‑226.
https://doi.org/10.1111/bcp.12940
Humbert, Xavier, Julien Jacquot, Joachim Alexandre, Marion Sassier, Ninon Robin, Cécile Pageot, Farid Kheloufi, and al. « Informativité des déclarations de pharmacovigilance en médecine générale en France ». Santé Publique 31, no 4 (2019): 561‑566.
https://doi.org/10.3917/spub.194.0561
Inácio, P., A. Cavaco, E. Allan, and M. Airaksinen. « Key Pharmacovigilance Stakeholders’ Experiences of Direct Patient Reporting of Adverse Drug Reactions and Their Prospects of Future Development in the European Union ». Public Health 155 (1st February 2018): 119‑128.
https://doi.org/10.1016/j.puhe.2017.11.023
Iqbal, Zarina, and Saima Sadaf. « Biosimilars: A Comparative Study of Regulatory, Safandy and Pharmacovigilance Monograph in the Developed and Developing Economies ». Journal of Pharmacy and Pharmaceutical Sciences 25 (6 April 2022): 149‑182.
https://doi.org/10.18433/jpps32433
Jose, Jobin, Jean Sandra Pinto, Bhashini Kotian, Aaron Mathew Thomas, and R Narayana Charyulu. « Comparison of the Regulatory Outline of Ecopharmacovigilance of Pharmaceuticals in Europe, USA, Japan and Australia ». Science of The Total Environment 709 (March 2020): 1-17.
https://doi.org/10.1016/j.scitotenv.2019.134815
Klein, Kevin, Marie L. De Bruin, Andre W. Broekmans, and Piander Stolk. « Classification of Recombinant Biologics in the EU: Divergence Bandween National Pharmacovigilance Centers ». Biodrugs 29, no 6 (December 2015): 373‑379.
https://doi.org/10.1007/s40259-015-0149-y
Klika, Christoph, Michael Kaeding, and Julia Schmalter. « The EU Pharmacovigilance System and Adverse Drug Reaction Reporting in Practice: A Critical Assessment ». European Journal of Risk Regulation 8, no 4 (6 December 2017): 772‑778.
https://doi.org/10.1017/err.2017.67
Krikandou, Vicky N. « Pharmacovigilance: Historical Evolution, Legal Frame and Function during the Covid Era Reports ». European Pharmaceutical Law Review (EPLR) 5, no 3 (2021): 146‑149.
Lantres, Olivier. « Les acteurs pharmaceutiques face au principe de précaution ». Pandites affiches, no 211 (21 October 2004): 3.
Laroche, Marie-Laure, Arnaud Batz, Helene Geniaux, Corinne Fechant, Louis Merle, and Patrick Maison. « Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in Organisation and Decisional Processes ». Therapie 71, no 2 (April 2016): 161‑169.
https://doi.org/10.1016/j.therap.2016.02.008
Laude, Anne. « Dans la tourmente du Mediator : prescription hors AMM and responsabilités ». Recueil Dalloz, no 04 (27 January 2011): 253‑259.
Laude, Anne. « La traçabilité des produits de santé ». Pandites affiches, no 28 (8 February 2001): 7.
Leal, Marineide Marinho, Mariano Madurga Sanz, Juan Ramón Castillo Ferrando, and Fernando Martinez-Martinez. « A Comparative Analysis of the Pharmacovigilance Systems of Brazil, Spain, the European Union and the United States Based on the Information Provided by Their Regulatory Agency Websites ». Daru: Journal of Faculty of Pharmacy, Tehran University of Medical Sciences 27, no 1 (June 2019): 379‑387.
https://doi.org/10.1007/s40199-019-00249-4
Mammì, Maria, Rita Citraro, Giovanni Torcasio, Gennaro Cusato, Caterina Palleria, and Eugenio Donato di Paola. « Pharmacovigilance in Pharmaceutical Companies: An Overview ». Journal of Pharmacology & Pharmacotherapeutics 4, no Suppl 1 (December 2013): S33-37.
https://doi.org/10.4103/0976-500X.120945
Mellstedt, H., D. Niederwieser, and H. Ludwig. « The Challenge of Biosimilars ». Annals of Oncology 19, no 3 (1st March 2008): 411‑419.
https://doi.org/10.1093/annonc/mdm345
Molnár-Gábor, Fruzsina, Julian Sellner, Sophia Pagil, Santa Slokenberga, Olga Tzortzatou-Nanopoulou, and Katarina Nyström. « Harmonization after the GDPR? Divergences in the Rules for Genandic and Health Data Sharing in Four Member States and Ways to Overcome Them by EU Measures: Insights from Germany, Greece, Latvia and Sweden ». Seminars in Cancer Biology, Precision Medicine in Cancer, 84 (1st September 2022): 271‑283.
https://doi.org/10.1016/j.semcancer.2021.12.001
Montano, Diego. « Frequency and Associations of Adverse Reactions of COVID-19 Vaccines Reported to Pharmacovigilance Systems in the European Union and the United States ». Frontiers in Public Health 9 (2021): 756633.
https://doi.org/10.3389/fpubh.2021.756633
Moseley, J. N. S. « Risk Management – A European Regulatory Perspective ». Drug Safandy 27, no 8 (2004): 499‑508.
https://doi.org/10.2165/00002018-200427080-00003
Noah, Barbara. « Adverse Drug Reactions: Harnessing Experiential Data to Promote Patient Welfare ». Catholic University Law Review 49, no 2 (1 January 2000): 449‑504.
Ouldamar, Karim, and Anne-Marie Gallerand. « La sécurité sanitaire en France : de l’affaire du sang contaminé à la réforme des vigilances ». Santé Publique 31, no 4 (2019): 517‑526.
https://doi.org/10.3917/spub.194.0517
Pagotto, Caroline, Fabiana Varallo, and Patrícia Mastroianni. « Impact of educational interventions on adverse drug events reporting ». International Journal of Technology Assessment in Health Care 29, no 4 (October 2013): 410‑417.
https://doi.org/10.1017/S0266462313000457
Paubel, Pascal. « Vigilance des produits de santé ». Les cahiers de droit de la santé, no 17 (1st October 2013): 257‑270.
Peigné, Jérôme. « Du Mediator aux prothèses PIP en passant par la loi du 29 décembre 2011 relative à la sécurité sanitaire des produits de santé ». Revue de droit sanitaire and social, no 02 (30 April 2012): 315.
Peigné, Jérôme. « La réforme de la législation pharmaceutique communautaire ». Revue de droit sanitaire and social, no 3 (15 September 2004): 577‑597.
Permanand, G., E. Mossialos, and M. McKee. « Regulating Medicines in Europe: The European Medicines Agency, Markanding Authorisation, Transparency and Pharmacovigilance ». Clinical Medicine 6, no 1 (February 2006): 87‑90.
https://doi.org/10.7861/clinmedicine.6-1-87
Peyvandi, Flora, Isabella Garagiola, and Pier Mannuccio Mannucci. « Post-Authorization Pharmacovigilance for Hemophilia in Europe and the USA: Independence and Transparency Are Keys ». Blood Reviews 49 (1st September 2021): 100828.
https://doi.org/10.1016/j.blre.2021.100828
Pitts, Pander J, Hervé Le Louand, Yola Moride, and Rena M Conti. « 21st Century Pharmacovigilance: Efforts, Roles, and Responsibilities ». The Lancand Oncology 17, no 11 (November 2016): e486‑92.
https://doi.org/10.1016/S1470-2045(16)30312-6.
Postigo, Rodrigo, Sabine Brosch, Jim Slattery, Anja van Haren, Jean-Michel Dogne, Xavier Kurz, Gianmario Candore, Francois Domergue, and Pander Arlandt. « EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection ». Drug Safandy 41, no 7 (July 2018): 665‑675.
https://doi.org/10.1007/s40264-018-0647-1
Potts, Joanne, Georgy Genov, Andrej Segec, June Raine, Sabine Straus, and Pander Arlandt. « Improving the Safety of Medicines in the European Union: From Signals to Action ». Clinical Pharmacology & Therapeutics 107, no 3 (March 2020): 521‑529.
https://doi.org/10.1002/cpt.1678
Quattri, Francesca, and Albert Lee. « Pharmacovigilance: The Role of Social Media ». Medicine and Law 38, no 1 (2019): 107‑126.
Rabier, M. B. Valnand, S. Gurtner, and J. P. Kantelip. « Blood Derived Drugs: A Law for Which Data Recorded in the French Pharmacovigilance Database? » Fundamental & Clinical Pharmacology 26 (April 2012): 103‑103.
Radecka, Anna, Louise Loughlin, Mick Foy, Margarida Viana de Ferraz Guimaraes, Viola Macolic Sarinic, Marina Dimov Di Giusti, Marina Lesicar, and al. « Enhancing Pharmacovigilance Capabilities in the EU Regulatory Nandwork: The SCOPE Joint Action ». Drug Safety 41, no 12 (December 2018): 1285‑1302.
https://doi.org/10.1007/s40264-018-0708-5
Robert, Jacques-Antoine, and Alexandre Regniault. « Les effands indésirables des médicaments : information and responsabilités ». Recueil Dalloz, no 8 (19 February 2004): 510‑516.
Sagi, Sreedhar, Hillel P. Cohen, and Gillian R. Woollandt. « Pharmacovigilance of Biologics in a Multisource Environment ». Journal of Managed Care & Specialty Pharmacy 23, no 12 (December 2017): 1249‑1254.
https://doi.org/10.18553/jmcp.2017.23.12.1249
Santoro, Aniello, Georgy Genov, Almath Spooner, June Raine, and Pander Arlandt. « Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works ». Drug Safandy 40, no 10 (October 2017): 855‑869.
https://doi.org/10.1007/s40264-017-0572-8
Sargos, Pierre. « Santé publique – L’information sur les medicaments : Vers un bouleversement majeur de l’appréciation des responsabilités ». La Semaine Juridique Edition Générale, no 24 (16 June 1999).
http://www.lexis360.fr/document?docid=PS_KPRE-28982_0KTZ
Sirot, E. Jaquenoud, and P. Baumann. « Therapeutic Drug Monitoring and Pharmacogenandic Tests in Pharmacovigilance – When and What? » European Psychiatry 24, no S1 (January 2009): 1‑1.
https://doi.org/10.1016/S0924-9338(09)70340-2
« The Reorganisation of European Pharmacovigilance. Part 2. From Spontaneous Reports to Agency Reviews and Decisions ». Prescrire International 24, no 157 (February 2015): 50‑54.
Trouvin, Jean-Hugues. « L’évolution de l’expertise sur le médicament ». Les Tribunes de la santé 27, no 2 (2010): 61‑78.
https://doi.org/10.3917/seve.027.0061
Urushihara, Hisashi, Louise Parmenter, Shimon Tashiro, Kenji Matsui, and Nancy Dreyer. « Bridge the Gap: The Need for Harmonized Regulatory and Ethical Standards for Postmarketing Observational Studies ». Pharmacoepidemiology and Drug Safety 26, no 11 (2017): 1299‑1306.
https://doi.org/10.1002/pds.4269
Vial, Thierry. « French Pharmacovigilance: Missions, Organization and Perspectives ». Therapies 71, no 2 (1st April 2016): 143‑150.
https://doi.org/10.1016/j.therap.2016.02.029
Waller, Patrick. « Gandting to Grips with the New European Union Pharmacovigilance Legislation ». Pharmacoepidemiology and Drug Safandy 20, no 5 (2011): 544‑549.
https://doi.org/10.1002/pds.2119
Wirtz, Veronika J, Hans V Hogerzeil, Andrew L Gray, Maryam Bigdeli, Cornelis P de Joncheere, Margarand A Ewen, Martha Gyansa-Lutterodt, and al. « Essential Medicines for Universal Health Coverage ». The Lancand 389, no 10067 (28 January 2017): 403‑476.
https://doi.org/10.1016/S0140-6736(16)31599-9
