プロフィール詳細

プロジェクトを作成

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Dr. Alexandra A.に依頼

Portugal

Medical Devices 💊| Biocompatibility 🧪| Sterilization 🧫 | Regulatory Affairs 📝 | Radiation☢️

プロフィール概要

With 16 years of industry and academic experience combined in the medical device and interventional oncology fields, I am passionate about aligning regulatory strategy and compliance to deliver high-quality technical documentation and solutions.

専門分野

• ☆ Polymer Chemistry
• ☆ Analytical Chemistry
• ☆ Particle Size Distribution
• ☆ Radiochemistry
• ☆ Particle Physics
• ☆ Drug Development
• ☆ Preclinical Research
• ☆ In vitro Preclinical Toxciology
• ☆ In vivo Preclinical Toxicology
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Oncology
• ☆ Radiation Therapy
• ☆ Shelf-Life Testing
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Validation
• ☆ Packaging Design
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Formulation, Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Packaging Design, Device Fabrication

職務経験

Senior Associate / Subject Matter expert

Terumo Europe

9月 2019 - 6月 2025

Senior Associate

University Medical Center Utrecht

9月 2016 - 8月 2019

Junior Associate

iMED - Research Institute for Medicines

3月 2010 - 11月 2012

学歴

PhD

University of Strasbourg

12月 2012 - 11月 2015

MSc

University of Lisbon - Faculty of Pharmacy

1月 2006 - 1月 2012

認定資格

• Sterilization Professionals Certification Program

  COBBLESTONE

  5月 2025 - 現在

• Process Validation

  Medical Device HQ

  11月 2024 - 現在

• Advanced Risk Management for Medical Devices and ISO xxxxxxxxxx

  Medical Device HQ

  10月 2024 - 現在

• Requirements Engineering for Medical Devices

  Medical Device HQ

  5月 2024 - 現在

• Regulatory Affairs Certification (RAC)

  Regulatory Affairs Professionals Society (RAPS)

  5月 2024 - 現在

• Quality Management for Medical Devices and ISO 13485

  Medical Device HQ

  5月 2023 - 現在

• Biological Safety Specialist (ISO 10993)

  NAMSA

  1月 2018 - 現在

• Radiation Safety Level 5B

  TUDelft

  5月 2014 - 現在

出版物

JOURNAL ARTICLE

Alexandra Arranja, Nienke Klaassen, Lieke Ruven, Stephan van Maurik, Jan Willem Hesselink, Frank Nijsen, Sebastiaan van Nimwegen (2025). Optimization of holmium-166 microspheres suspension for intratumoral microbrachytherapy . Journal of Drug Delivery Science and Technology.

Alexandra Arranja, Anne van den Brekel, Tess Snoeijink, Vincent E. de Meijer, Milou Boswinkel, Koert de Jong, Joey Roosen, jurgen futterer, Simeon Ruiter, Frank Nijsen (2025). Spatial distribution of fractionally administered holmium microspheres in non-tumorous human liver tissue: how livers survive transarterial radioembolisation . EJNMMI Research.

Alexandra Arranja, Nienke Klaassen, Gerrit van de Maat, Milou Boswinkel, Robin Bruggink, Ilva van Houwelingen, Irene Schaafsma, Jan Willem Hesselink, Frank Nijsen, Bas van Nimwegen, et al. (2024). Quantitative CT imaging and radiation-absorbed dose estimations of 166Ho microspheres: paving the way for clinical application . European Radiology Experimental.

Alexandra Arranja, Sander Oldenhof, Serhii Mytnyk, Marcel de Puit, Jan van Esch (2020). Imaging-assisted hydrogel formation for single cell isolation . Scientific Reports.

A.G. Arranja, W.E. Hennink, C. Chassagne, A.G. Denkova, J.F.W. Nijsen (2020). Preparation and characterization of inorganic radioactive holmium-166 microspheres for internal radionuclide therapy . Materials Science and Engineering: C.

Kas J. Houthuijs, Jonathan Martens, Alexandra G. Arranja, Giel Berden, J. Frank W. Nijsen, Jos Oomens (2020). Characterization of holmium(<scp>iii</scp>)-acetylacetonate complexes derived from therapeutic microspheres by infrared ion spectroscopy . Physical Chemistry Chemical Physics.

Nienke J. M. Klaassen, Mark J. Arntz, Alexandra Gil Arranja, Joey Roosen, Frank Nijsen (2019). The various therapeutic applications of the medical isotope holmium-166: a narrative review . EJNMMI Radiopharmacy and Chemistry.

A.G. Arranja, W.E. Hennink, A.G. Denkova, R.W.A. Hendrikx, J.F.W. Nijsen (2018). Radioactive holmium phosphate microspheres for cancer treatment . International Journal of Pharmaceutics.

R.M. de Kruijff, A. Arranja, A.G. Denkova (2018). Radiolabeling Methods and Nuclear Imaging Techniques in the Design of New Polymeric Carriers for Cancer Therapy . Current Applied Polymer Science.

Alexandra Arranja, Kai Zhang, Hongyu Chen, Serhii Mytnyk, Yiming Wang, Sander Oldenhof, Job Boekhoven, Eduardo Mendes (2018). A nano-fibrous platform of copolymer patterned surfaces for controlled cell alignment . RSC Advances.

Costanza Santini, Alexandra G. Arranja, Antonia G. Denkova, Fran&#231;ois Schosseler, Karolina Morawska, Peter Dubruel, Eduardo Mendes, Marion de Jong, Monique R. Bernsen (2017). Intravenous and intratumoral injection of Pluronic P94: The effect of administration route on biodistribution and tumor retention . Nanomedicine: Nanotechnology, Biology and Medicine.

Alexandra G. Arranja, Vertika Pathak, Twan Lammers, Yang Shi (2017). Tumor-targeted nanomedicines for cancer theranostics . Pharmacological Research.

Alexandra Arranja, Oleksandra Ivashchenko, Antonia G. Denkova, Karolina Morawska, Sandra van Vlierberghe, Peter Dubruel, Gilles Waton, Freek J. Beekman, Fran&#231;ois Schosseler, Eduardo Mendes (2016). SPECT/CT Imaging of Pluronic Nanocarriers with Varying Poly(ethylene oxide) Block Length and Aggregation State . Molecular Pharmaceutics.

Alexandra Arranja, Lu&#237;s F. Gouveia, Petra Gener, Diana F. Rafael, Carolina Pereira, Sim&#243; Schwartz, Mafalda A. Videira (2016). Self-assembly PEGylation assists SLN-paclitaxel delivery inducing cancer cell apoptosis upon internalization . International Journal of Pharmaceutics.

Alexandra Arranja, Jonathan Martinelli, Antonia G. Denkova, Baukje E. Terpstra, Wuyuan Zhang, Kristina Djanashvili (2016). Fate of Organic Functionalities Conjugated to Theranostic Nanoparticles upon Their Activation . Bioconjugate Chemistry.

Alexandra Arranja, Antonia G. Denkova, Karolina Morawska, Gilles Waton, Sandra van Vlierberghe, Peter Dubruel, Fran&#231;ois Schosseler, Eduardo Mendes (2016). Interactions of Pluronic nanocarriers with 2D and 3D cell cultures: Effects of PEO block length and aggregation state . Journal of Controlled Release.

Alexandra Arranja, Gilles Waton, Fran&#231;ois Schosseler, Eduardo Mendes (2016). Lack of a unique kinetic pathway in the growth and decay of Pluronic micelles . Soft Matter.

Alexandra Arranja, Petra Gener, Luis Pleno Gouveia, Guillem Romero Sabat, Diana Fernandes de Sousa Rafael, N&#250;ria Bergad&#224; Fort, Yolanda Fern&#225;ndez, Rafael Mi&#241;ana Prieto, Joan Sayos Ortega, Diego Arango, et al. (2015). Fluorescent CSC models evidence that targeted nanomedicines improve treatment sensitivity of breast and colon cancer stem cells . Nanomedicine: Nanotechnology, Biology and Medicine.

Alexandra Arranja, Andr&#233; P. Schroder, Marc Schmutz, Gilles Waton, Fran&#231;ois Schosseler, Eduardo Mendes (2014). Cytotoxicity and internalization of Pluronic micelles stabilized by core cross-linking . Journal of Controlled Release.

M. Videira, A. Arranja, D. Rafael, R. Gaspar (2014). Preclinical development of siRNA therapeutics: Towards the match between fundamental science and engineered systems . Nanomedicine: Nanotechnology, Biology and Medicine.

Mafalda A. Videira, Alexandra G. Arranja, Lu&#237;s F. Gouveia (2013). Experimental design towards an optimal lipid nanosystem: A new opportunity for paclitaxel-based therapeutics . European Journal of Pharmaceutical Sciences.