プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

Dr. Sergio P.に依頼

Spain

MDR Consultant / CER writer

プロフィール概要

I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me with a critical thinking, the capability to understand, analyze and summarize the results got during the experiments. 7 articles published in high impact factor journals in only 5 years showed my skills to plan, conduct experiments and get key results. Besides, I have experience in the pharmaceutical industry as medical information analyst/medical affairs . Here I got training about different therapeutic areas (Oncology, Diabetes, Osteoporosis) and the ability and expertise to perform literature research in different databases I have extensive experience writing monographs, elaborating PowerPoints, scientific studies and other scientific materials. Also, I have experience in the medical devices field, with the adapatation of CER to the new legislation, and update of the technical documentation to be alligned with the MDR Finally, I have experience in the regulatory part of the drug development, having participated in the NDA submission for the FDA and also planning the milestones for the EU submission

専門分野

• ☆ STEM
• ☆ Biology/Life Sciences
• ☆ Text Mining & Analytics
• ☆ Pharmaceutical Sciences
• ☆ Drug Development
• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Oncology
• ☆ Diabetes
• ☆ Medical Affairs
• ☆ Osteoporosis
• ☆ Research Methodology
• ☆ Clinical Evaluation Reports (CER)
• ☆ Management Information Systems

サービス

• Writing
• Research
• Consulting
• Product Development

職務経験

Regulatory Project Planner

Pharma Mar

9月 2019 - 現在

Regulatory Specialist and Project Manager

Paul Hartmann

6月 2018 - 9月 2019

Senior Manager Clinical Evaluation Premarket

Hartmann (Germany)

1月 2018 - 5月 2018

Medical Information Analyst

Eli Lilly (Ireland)

7月 2015 - 12月 2017

Medical Affairs

Meisys (Spain)

2月 2014 - 6月 2015

Postdoctoral Researcher

Royal College of Surgeons in Ireland

10月 2010 - 2月 2013

学歴

Masters program about drug development

ESAME

9月 2013 - 6月 2014

Phd

University of Castilla la Mancha, Spain

10月 2007 - 10月 2010

Biology bachelor's degree

University of salamanca

9月 2002 - 6月 2007

認定資格

• 認定資格の詳細は未入力です。

出版物

JOURNAL ARTICLE

Düssmann H, Perez-Alvarez S, Anilkumar U, Papkovsky DB, Prehn JH(2017). Single-cell time-lapse imaging of intracellular O2 in response to metabolic inhibition and mitochondrial cytochrome-c release . Cell death & disease.

D'Orsi B, Kilbride SM, Chen G, Perez Alvarez S, Bonner HP, Pfeiffer S, Plesnila N, Engel T, Henshall DC, Düssmann H, et al.(2015). Bax regulates neuronal Ca2+ homeostasis . The Journal of neuroscience : the official journal of the Society for Neuroscience.

Barros-Miñones L, Martín-de-Saavedra D, Perez-Alvarez S, Orejana L, Suquía V, Goñi-Allo B, Hervias I, López MG, Jordan J, Aguirre N, et al.(2013). Inhibition of calpain-regulated p35/cdk5 plays a central role in sildenafil-induced protection against chemical hypoxia produced by malonate . Biochimica et biophysica acta.

Perez-Alvarez S, Iglesias-Guimarais V, Solesio ME, Melero-Fernandez de Mera RM, Yuste VJ, Galindo MF, Jordán J(2011). Methadone induces CAD degradation and AIF-mediated necrotic-like cell death in neuroblastoma cells . Pharmacological research.

Perez-Alvarez S, Cuenca-Lopez MD, de Mera RM, Puerta E, Karachitos A, Bednarczyk P, Kmita H, Aguirre N, Galindo MF, Jordán J(2010). Methadone induces necrotic-like cell death in SH-SY5Y cells by an impairment of mitochondrial ATP synthesis . Biochimica et biophysica acta.

Garcia-Martinez EM, Sanz-Blasco S, Karachitos A, Bandez MJ, Fernandez-Gomez FJ, Perez-Alvarez S, de Mera RM, Jordan MJ, Aguirre N, Galindo MF, et al.(2010). Mitochondria and calcium flux as targets of neuroprotection caused by minocycline in cerebellar granule cells . Biochemical pharmacology.

Perez-Alvarez S, Solesio ME, Manzanares J, Jordán J, Galindo MF(2009). Lactacystin requires reactive oxygen species and Bax redistribution to induce mitochondria-mediated cell death . British journal of pharmacology.

Valdivia A, Pérez-Alvarez S, Aroca-Aguilar JD, Ikuta I, Jordán J(2009). Superoxide dismutases: a physiopharmacological update . Journal of physiology and biochemistry.