Manolina Kontaxaki
Medical & Safety Affairs Consultant & Toxicologist at Rni- Claim this Profile
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Bio
Experience
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Rni
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France
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Legal Services
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1 - 100 Employee
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Medical & Safety Affairs Consultant & Toxicologist
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Mar 2021 - Present
Medical Devices (Clinical Evaluation Report + Biological Evaluation Report) Novel Food Dossiers (Toxicological part) Cosmetics (Safety assessment Reports) Pharmaceuticals (Periodic Safety Update Reports ) Safety assessments (Products under authorization | Risk Benefit profile estimation) Toxicological Risk Assessments (ISO 10993:part 17 | ICH Q3D (R1, R2, R3) Medical Devices (Clinical Evaluation Report + Biological Evaluation Report) Novel Food Dossiers (Toxicological part) Cosmetics (Safety assessment Reports) Pharmaceuticals (Periodic Safety Update Reports ) Safety assessments (Products under authorization | Risk Benefit profile estimation) Toxicological Risk Assessments (ISO 10993:part 17 | ICH Q3D (R1, R2, R3)
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Freelance
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Greece
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Medical & Safety Affairs Consultant
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Feb 2019 - Mar 2021
Medical Writting Risk assessment Reports Hazard assessment & Hazard Identification Bordeline Products (Medical Devices, Pharmaceuticals, Cosmetics, Biocides) Human health reports Active Ingredients scientific and tox review Medical Writting Risk assessment Reports Hazard assessment & Hazard Identification Bordeline Products (Medical Devices, Pharmaceuticals, Cosmetics, Biocides) Human health reports Active Ingredients scientific and tox review
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SUSTCHEM S.A.
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Greece
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Business Consulting and Services
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1 - 100 Employee
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Qualified Person for Pharmacovigilance (EU QPPV)
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Feb 2015 - May 2018
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Regulatory Affairs Consultant
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Sep 2014 - May 2018
Experience in Chemicals:Classification, Labelling and Packaging of mixtures and substance according to CLP Regulation (1272/2008/EE)REACH Reg. (EC) 1907/2006 Disinfectants, detergents, adhesives, cements, paints, varnishes, etc.Safety Data Sheet review and authoring according to REACH Reg. and (EU) 830/2015 Reg.Regulation (EC) No 648/2004 for detergents and its amendmentsProduct compliance according to European Regulations and national directives (label, SDS, TDS packaging, etc.) Tobacco Products Directive (2014/40/EU) for liquids of electronic cigarettes. Show less
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Toxicologist
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Sep 2014 - May 2018
Toxicological assessment reportsToxicological data review and submission to authoritiesClinical Evaluation Reports (Medical Devices)Health-based exposure limits (HBEL) and Permitted Daily Exposure limits (PDE)
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NCSR "DEMOKRITOS"
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Greece
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Research Services
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200 - 300 Employee
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Laboratory and Research Assistant
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Jan 2014 - Jul 2014
• Study on degradation of 2,4 DCP and cyanotoxin Cylindrospermopsin (CYN) with UV-Radiation using polyoxometalate, TiO2 and impregnated TiO2-POM , analysis by HPLC-UV and LC-MS/MS. • Water sample analysis for volatile odor compounds (Geosmine and MIB) by using GC-MS. • Study on degradation of 2,4 DCP and cyanotoxin Cylindrospermopsin (CYN) with UV-Radiation using polyoxometalate, TiO2 and impregnated TiO2-POM , analysis by HPLC-UV and LC-MS/MS. • Water sample analysis for volatile odor compounds (Geosmine and MIB) by using GC-MS.
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RIVM National Institute for Public Health and the Environment
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Netherlands
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Research Services
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700 & Above Employee
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Environmental Fate of Organic Micropollutants in groundwater
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Jun 2013 - Aug 2013
Literature review on environmental fate and degradation of five organic micro-pollutants which have been found the last decades in water sources. These compounds are: methyl tert-butyl ether (MTBE), bisphenol-A (BPA), metformine, metolachlor and mecoprop. Degradation was studied under aerobic and anaerobic conditions.
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Research Assistant - Metal sorption to soil and metal toxicity to earthworms
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Jan 2013 - Aug 2013
Testing: • How metals (Cd,Cu,Zn,Ni,Pb,Ag) are sorbed to soil particles and • Metal toxicity to earthworms (App. Caliginosa, App. Longa, as the tested animals). LC50 and mortality measurments. Statistical analysis was done by using Microsoft E-xcel and Graphpad Prism.
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IRAS
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Utrecht Area, Netherlands
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Research Assistant - Sorption of ionized compounds to dissolved organic matter (DOM) in water
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Jan 2012 - Oct 2012
This study was conducted to test how pH, dissolved organic carbon concentration and ionic strength affect the sorption of polar organic compounds (promazine, chlorpromazine and triflupromazine) to dissolved organic matter (DOM) in water. The experiments were performed by using SPME technique combined with HPLC/UV analysis. This study was conducted to test how pH, dissolved organic carbon concentration and ionic strength affect the sorption of polar organic compounds (promazine, chlorpromazine and triflupromazine) to dissolved organic matter (DOM) in water. The experiments were performed by using SPME technique combined with HPLC/UV analysis.
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Center of Toxicological Sciences and Research
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Heraklion Crete Greece
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Research Assistant - Study of pesticides and their metabolites in biological samples
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May 2010 - Aug 2010
Processing and measuring of plant protection products and their metabolites in biological samples (hair and urine) by using LC-MS. Processing and measuring of plant protection products and their metabolites in biological samples (hair and urine) by using LC-MS.
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Chemical Laboratory "Analysis"
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Heraklion, Crete, Greece
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Laboratory assistant - Analysis of oil quality
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Oct 2007 - Dec 2007
Olive oil quality analysis by using optical spectrometry. Processed and assessed analysis results Olive oil quality analysis by using optical spectrometry. Processed and assessed analysis results
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Education
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Universiteit Utrecht
Master -
University of Crete, Greece
Chemistry