EJHP booklet for EAHP 2024

EAHP position paper

REFERENCES 1 Communication from the commission to the european parliament, the council, the european economic and social committee and the committee of the regions, pharmaceutical strategy for europe, COM/2020/761 final. Available: https://eur-lex. europa.eu/legal-content/EN/ALL/?uri=CELEX:52020DC0761 [Accessed 15 Feb 2022]. 2 European Medicines Agency. EMA regulatory science to 2025. Available: www.ema. europa.eu/en/documents/regulatory-procedural-guideline/ema-regulatory-science- 2025-strategic-reflection_en.pdf [Accessed 15 Feb 2022]. 3 Regulation (EC) no. 1394/2007 of the european parliament and of the council of 13 november 2007 on advanced therapy medicinal products and amending directive 2001/83/ EC and regulation (EC) no 726/2004, OJ L 324/121; 2007. 4 European Medicines Agency. Reflection paper on classification of advanced therapy medicinal products, 21 may 2015. Available: www.ema.europa.eu/en/documents/ scientific-guideline/reflection-paper-classification-advanced-therapy-medicinal- products_en-0.pdf [Accessed 15 Feb 2022]. 5 Meij P, Canals JM, Lowery M, et al . Advanced therapy medicinal products. Leuven, Belgium LERU; 2019. Available: www.regenhealthsolutions.info/wp-content/uploads/ 2019/10/LR-BP-ATMP.pdf [Accessed 23 Feb 2022]. 6 ATMP. The role of pharmacy in the successful delivery of Advanced Therapy Medicinal Products (ATMP). Information for chief pharmacists. 1st ed. February 2017. Advanced Therapy Medicinal Products Working Party; 2017. Available: https://atmpmanufacture. org/wp-content/uploads/2017/03/ATMP-V1-Advice-for-Chief-Pharmacists.pdf [Accessed 23 Feb 2022]. 7 Mebarki M, Madelaine I, Larghero J, et al . Advanced therapy medicinal products: regulatory framework, hospital and pharmaceutical circuits in Europe and France. Therapies 2022;77:185–90. 8 Verbeken G, Draye JP, Fauconnier A, et al . The magistral preparation of advanced therapy medicinal products (ATMPs). 2020. Available: http://globalsciencelibrary.com/ article/The+Magistral+Preparation+of+Advanced+Therapy+Medicinal+Products+% 28ATMPs%29 [Accessed 23 Feb 2023].

9 Moreno-Martínez ME, Vinent-Genestar J, Muñoz-Sánchez C, et al . Hospital pharmacist’s roles and responsibilities with CAR-T medicines. Farm Hosp 2020;44:26–31. 10 Mansur JM. Medication safety systems and the important role of pharmacists. Drugs Aging 2016;33:213–21. 11 Toklu HZ, Mensah E. Why do we need pharmacists in pharmacovigilance systems? Online J Public Health Inform 2016;8:e193. 12 Eichler HG, Pignatti F, Schwarzer-Daum B, et al . Randomized controlled trials versus real world evidence: neither magic nor myth. Clin Pharmacol Ther 2021;109:1212–8. 13 Vulto A. European association of hospital pharmacists (EAHP) guidance on the pharmacy handling of gene medicines; 2007. 14 EAHP special interest group focused on hospital pharmacist’s preparedness for in-vivo gene therapy medicinal products. Available: www.eahp.eu/hp-practice/hospital- pharmacy/SIGs/GeneTherapy [Accessed 30 Mar 2022]. 15 Stoner N. Are UK hospital pharmacy departments ready for the rise of gene therapy medicinal products? Expert Opin Biol Ther 2018;18:837–40. 16 European Association of Hospital Pharmacists. EU monitor - learn more about EAHP’s special interest groups. 2021. Available: www.eahp.eu/news/EU-monitor/eu-monitor- 13th-october-2021-learn-more-about-eahp%E2%80%99s-special-interest-groups [Accessed 02 Mar 2022]. 17 Guiu Segura JM. Advancing hospital pharmacy practice through new competences in advanced therapy medicinal products. Am J Pharm Educ 2014;78:22. 18 Bignami F, Kent AJ, Lipucci di Paola M, et al . Participation of patients in the development of advanced therapy medicinal products. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 2011;54:839–42. 19 Lamas-Díaz MJ, Hernández-García C. Advanced therapies. Farm Hosp 2020;44:1–2. 20 Champion AR, Lewis S, Davies S, et al . Managing access to advanced therapy medicinal products: challenges for NHS Wales. Br J Clin Pharmacol 2021;87:2444–9. 21 Guiu Segura JM. Advancing Hospital pharmacy practice through new competences in advanced therapy medicinal products. Am J Pharm Educ 2014;78:22.

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