Vamvakas S - Search Results

1

Marketing authorisation of orphan medicines in Europe from 2000 to 2013.

Hofer MP, Hedman H, Mavris M, Koenig F, Vetter T, Posch M, Vamvakas S, Regnstrom J, Aarum S. Hofer MP, et al. Among authors: vamvakas s. Drug Discov Today. 2018 Feb;23(2):424-433. doi: 10.1016/j.drudis.2017.10.012. Epub 2017 Oct 23. Drug Discov Today. 2018. PMID: 29074441 Free article. Review.

2

Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.

Regnstrom J, Koenig F, Aronsson B, Reimer T, Svendsen K, Tsigkos S, Flamion B, Eichler HG, Vamvakas S. Regnstrom J, et al. Among authors: vamvakas s. Eur J Clin Pharmacol. 2010 Jan;66(1):39-48. doi: 10.1007/s00228-009-0756-y. Epub 2009 Nov 20. Eur J Clin Pharmacol. 2010. PMID: 19936724

3

Regulatory watch: Impact of scientific advice from the European Medicines Agency.

Hofer MP, Jakobsson C, Zafiropoulos N, Vamvakas S, Vetter T, Regnstrom J, Hemmings RJ. Hofer MP, et al. Among authors: vamvakas s. Nat Rev Drug Discov. 2015 May;14(5):302-3. doi: 10.1038/nrd4621. Epub 2015 Apr 17. Nat Rev Drug Discov. 2015. PMID: 25881970 No abstract available.

4

Multistakeholder Advice at the European Medicines Agency: Is It Still Needed?

Vamvakas S, Moseley J, Vetter T. Vamvakas S, et al. Clin Pharmacol Ther. 2019 Apr;105(4):819-821. doi: 10.1002/cpt.1335. Epub 2019 Feb 27. Clin Pharmacol Ther. 2019. PMID: 30811587 No abstract available.

5

The Added Value of Patient Engagement in Early Dialogue at EMA: Scientific Advice as a Case Study.

Murphy A, Bere N, Vamvakas S, Mavris M. Murphy A, et al. Among authors: vamvakas s. Front Med (Lausanne). 2022 Jan 20;8:811855. doi: 10.3389/fmed.2021.811855. eCollection 2021. Front Med (Lausanne). 2022. PMID: 35127766 Free PMC article.

6

Role of modeling and simulation in pediatric investigation plans.

Manolis E, Osman TE, Herold R, Koenig F, Tomasi P, Vamvakas S, Saint Raymond A. Manolis E, et al. Among authors: vamvakas s. Paediatr Anaesth. 2011 Mar;21(3):214-21. doi: 10.1111/j.1460-9592.2011.03523.x. Epub 2011 Jan 18. Paediatr Anaesth. 2011. PMID: 21244569 Review.

7

Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude.

Ehmann F, Papaluca Amati M, Salmonson T, Posch M, Vamvakas S, Hemmings R, Eichler HG, Schneider CK. Ehmann F, et al. Among authors: vamvakas s. Clin Pharmacol Ther. 2013 May;93(5):425-32. doi: 10.1038/clpt.2013.14. Epub 2013 Jan 24. Clin Pharmacol Ther. 2013. PMID: 23549149

8

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: vamvakas s. 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.

9

The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

Haas M, Mantua V, Haberkamp M, Pani L, Isaac M, Butlen-Ducuing F, Vamvakas S, Broich K. Haas M, et al. Among authors: vamvakas s. Nat Rev Drug Discov. 2015 Apr;14(4):221-2. doi: 10.1038/nrd4585. Nat Rev Drug Discov. 2015. PMID: 25829266

10

New pathway for qualification of novel methodologies in the European Medicines Agency.

Manolis E, Vamvakas S, Isaac M. Manolis E, et al. Among authors: vamvakas s. Proteomics Clin Appl. 2011 Jun;5(5-6):248-55. doi: 10.1002/prca.201000130. Epub 2011 Apr 28. Proteomics Clin Appl. 2011. PMID: 21538915 Review.

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