Sepodes B - Search Results

1

Optimizing Patient Registries for Regulatory Decision Making - Key Learnings From an HMA/EMA Multistakeholder Workshop.

Plueschke K, Jonker C, Kankanen H, Vetter T, Sepodes B, Naehrlich L, Hillert J, Crane G, Straus S, Foggi P, Martin S, Kyriakopoulou C, Mol P, Day F, Breen K, Bennett N, de Lemus Belmonte M, Bennett S, Verpillat P, Roes KCB, Cochino A, Schaefer F, Hernández-Rivas JM, McGettigan P, Arlett P. Plueschke K, et al. Among authors: sepodes b. Clin Pharmacol Ther. 2025 Jun 2. doi: 10.1002/cpt.3733. Online ahead of print. Clin Pharmacol Ther. 2025. PMID: 40457718 Review.

2

Editorial: Insights in Regulatory Science 2021.

Sepodes B, Mol P. Sepodes B, et al. Front Med (Lausanne). 2022 Sep 20;9:1033558. doi: 10.3389/fmed.2022.1033558. eCollection 2022. Front Med (Lausanne). 2022. PMID: 36203766 Free PMC article. No abstract available.

3

Clinical Evidence 2030.

Arlett P, Umuhire D, Verpillat P, Foggi P, Wändel Liminga U, Sepodes B, Lunzer M, Aylward B, Vamvakas S, Roes K, Pétavy F, Thirstrup S, Lamas M, Cooke E, Broich K. Arlett P, et al. Among authors: sepodes b. Clin Pharmacol Ther. 2025 Apr;117(4):884-886. doi: 10.1002/cpt.3596. Epub 2025 Feb 14. Clin Pharmacol Ther. 2025. PMID: 39949283 Free PMC article. No abstract available.

4

Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Eichler HG, Koenig F, Arlett P, Enzmann H, Humphreys A, Pétavy F, Schwarzer-Daum B, Sepodes B, Vamvakas S, Rasi G. Eichler HG, et al. Among authors: sepodes b. Clin Pharmacol Ther. 2020 Apr;107(4):773-779. doi: 10.1002/cpt.1638. Epub 2019 Oct 1. Clin Pharmacol Ther. 2020. PMID: 31574163 Free PMC article. Review.

5

Stakeholders' Perspectives Toward the Use of Patient Registry Data for Decision-Making on Medicines: A Cross-Sectional Survey.

Windfuhr F, de Vries ST, Melinder M, Dahlqvist T, Almeida D, Sepodes B, Torre C, Wettermark B, Mol PGM. Windfuhr F, et al. Among authors: sepodes b. Drug Saf. 2025 Jul;48(7):753-765. doi: 10.1007/s40264-025-01528-7. Epub 2025 Feb 23. Drug Saf. 2025. PMID: 39987538 Free PMC article.

6

Leveraging patient experience data to guide medicines development, regulation, access decisions and clinical care in the EU.

Almeida D, Umuhire D, Gonzalez-Quevedo R, António A, Burgos JG, Verpillat P, Bere N, Sepodes B, Torre C. Almeida D, et al. Among authors: sepodes b. Front Med (Lausanne). 2024 May 23;11:1408636. doi: 10.3389/fmed.2024.1408636. eCollection 2024. Front Med (Lausanne). 2024. PMID: 38846141 Free PMC article. Review.

7

Clinical Trials for COVID-19: Can we Better Use the Short Window of Opportunity?

Eichler HG, Cavaleri M, Enzmann H, Scotti F, Sepodes B, Sweeney F, Vamvakas S, Rasi G. Eichler HG, et al. Among authors: sepodes b. Clin Pharmacol Ther. 2020 Oct;108(4):730-733. doi: 10.1002/cpt.1891. Epub 2020 Jun 12. Clin Pharmacol Ther. 2020. PMID: 32407539 Free PMC article. Review.

8

Comparative Analysis of Post-Authorization Measures for Advanced Medicinal Products Authorized in the European Union and in the United States of America Between 2009 and 2023.

Mandslay D, Almeida D, Marques A, Rocha J, Drafi F, Sepodes B, Torre C. Mandslay D, et al. Among authors: sepodes b. Clin Pharmacol Ther. 2025 Jan;117(1):73-93. doi: 10.1002/cpt.3410. Epub 2024 Aug 14. Clin Pharmacol Ther. 2025. PMID: 39140780 Review.

9

Review of studies evaluating the effectiveness of risk minimization measures for oncology medicinal products registered in the European Medicines Agency (HMA-EMA) catalogue: findings and lessons learned.

Monteiro J, Almeida D, Fernandes JP, Sepodes B, Torre C. Monteiro J, et al. Among authors: sepodes b. Expert Opin Drug Saf. 2025 Feb 26:1-12. doi: 10.1080/14740338.2025.2471530. Online ahead of print. Expert Opin Drug Saf. 2025. PMID: 39989100

10

Medicines for an aging population: The EMA perspective and policies.

Cerreta F, Iskra EB, Cupelli A, Sepodes B, Rönnemaa E, Rosa MM, Mayrhofer S, Trauffler M, Torre C, Berntgen M, Vucic K, Bahri P, Koch A, Herdeiro MT, Mirošević Skvrce N, Pallos J, Laslop A. Cerreta F, et al. Among authors: sepodes b. J Am Geriatr Soc. 2024 Sep;72(9):2921-2927. doi: 10.1111/jgs.18953. Epub 2024 May 17. J Am Geriatr Soc. 2024. PMID: 38757979

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