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WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.
Wadhwa M, Kang HN, Thorpe R, Knezevic I; following participants of the WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products; Aprea P, Bielsky MC, Ekman N, Heim HK, Joung J, Kurki P, Lacana E, Njue C, Nkansah E, Savkina M, Thorpe R, Yamaguchi T, Wadhwa M, Wang J, Weise M, Wolff-Holz E; Other participants; Representatives of the Developing Countries Vaccine Manufacturers Network; Representatives of the Emerging Biopharmaceutical Manufacturers Network; Representatives of the IFPMA; Representatives of IGBA; Representative of the Latin American Association of Pharmaceutical Industries; Representative of the Singapore Association of Pharmaceutical Industries; WHO Secretariat. Wadhwa M, et al. Biologicals. 2022 Apr;76:1-9. doi: 10.1016/j.biologicals.2022.03.001. Epub 2022 Apr 22. Biologicals. 2022. PMID: 35466023 Free PMC article.
Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.
Heikkinen I, Eskola S, Acha V, Morrison A, Walker C, Weil C, Bril A, Wegner M, Metcalfe T, Chibout SD, Chlebus M. Heikkinen I, et al. Among authors: acha v. Drug Discov Today. 2023 May;28(5):103526. doi: 10.1016/j.drudis.2023.103526. Epub 2023 Feb 14. Drug Discov Today. 2023. PMID: 36792005 Free article.
Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union.
Beattie S; Alliance for Regenerative Medicine (ARM), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Association for Bioindustries (EuropaBio). Beattie S, et al. Hum Gene Ther. 2021 Oct;32(19-20):997-1003. doi: 10.1089/hum.2021.058. Epub 2021 May 24. Hum Gene Ther. 2021. PMID: 33843251
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Moseley J, Vamvakas S, Berntgen M, Cave A, Kurz X, Arlett P, Acha V, Bennett S, Cohet C, Corriol-Rohou S, Du Four E, Lamoril C, Langeneckert A, Koban M, Pasté M, Sandler S, Van Baelen K, Cangini A, García S, Obach M, Gimenez Garcia E, Varela Lema L, Jauhonen HM, Rannanheimo P, Morrison D, Van De Casteele M, Strömgren A, Viberg A, Makady A, Guilhaume C. Moseley J, et al. Among authors: acha v. Br J Clin Pharmacol. 2020 Jun;86(6):1034-1051. doi: 10.1111/bcp.14279. Epub 2020 Apr 24. Br J Clin Pharmacol. 2020. PMID: 32162368 Free PMC article. Review.
Collaboration for new therapies: maximizing health and innovation.
Mestre-Ferrandiz J, Meulien P, Ostwald DA, Acha V. Mestre-Ferrandiz J, et al. Among authors: acha v. Front Public Health. 2024 Sep 19;12:1383107. doi: 10.3389/fpubh.2024.1383107. eCollection 2024. Front Public Health. 2024. PMID: 39363986 Free PMC article.
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