Patrícia S. Perez
Team Manager Medical Writing & Senior Consultant at Qserve Group- Claim this Profile
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Português Native or bilingual proficiency
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Inglês Native or bilingual proficiency
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Espanhol Professional working proficiency
Topline Score
Bio
Credentials
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RAPS member
Regulatory Affairs Professionals Society (RAPS)Oct, 2021- Nov, 2024
Experience
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Qserve Group
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Netherlands
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Business Consulting and Services
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1 - 100 Employee
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Team Manager Medical Writing & Senior Consultant
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Nov 2022 - Present
• Managing the medical writing team.• Developing SOPs and best practices for the clinical writing team in accordance with the current regulations.• Expertise in clinical strategy for medical devices for different target markets (ANVISA, CE, FDA, MDSAP, TGA).• Supporting Product Design Development and Regulatory Affairs in biological and clinical issues.• Training and expert advice on the interpretation and implementation of the EU Medical Device Regulation (MDR) regarding biological and clinical requirements.• Elaborating biocompatibility documentation (ISO 10993 series) and clinica evaluations (MEDDEV 2.7/1 rev. 4 and MDR).• Assessment of clinical claims support and data collection remediation strategy under MDR.• Expertise in systematic literature search designing, planning, executing, and reporting.• Clinical writing (BEPs, BERs, CEPs, CERs, PMCFP, PMCFR, eCTD).• Supporting the implementation of a Post-Market Clinical Follow-up program for medical devices. Show less
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Consultant / Clinical Evaluation & Biological Safety
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Sep 2021 - Oct 2022
• Supporting and training for medical device manufacturers to be in compliance with the current regulations (CE, FDA, MDSAP).• Clinical strategies in accordance with MDR.• Systematic literature searches in accordance to MEDDEV. 2.7/1 rev. 4.• Clinical Evaluation Plans and Reports (CEP/CER) in accordance to MEDDEV. 2.7/1 rev. 4, MDR and TGA.• Biological Safety Assessments in accordance to ISO 10993 series.• Gap assessment in clinical and biological data in accordance with standardized requirements (MDR, MDSAP, ISO 10993 series).• Elaborating eCTD for combination products. Show less
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Neodent
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Brazil
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Medical Equipment Manufacturing
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700 & Above Employee
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Biocompatibility and Clinical Evaluation Coordinator
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May 2018 - Sep 2021
• Coordinating and reviewing Biological Safety Assessment Plans and Reports in accordance to ISO 10993-1, Toxicological Analysis in accordance to ISO 10993-17, Literature Search Plans and Reports and Clinical Evaluation Plans and Reports in accordance to MEDDEV. 2.7/1 rev. 4 and MDD/MDR.• Working with dental implants, aligners, prosthetic abutments, instruments and resins.• Subject Matter Expert (SME) regarding biocompatibility and clinical evaluation for internal and external audits, including those from ANVISA, FDA, CE and MDSAP.• Supporting Product Design Development and Regulatory Affairs in biological, toxicological, clinical and biocompatibility issues.• Part of the development of the Zinedent, GM, Helix, Zi and Nuvo lines. • Support in Post-Market Clinical Follow-up (PMCF) in accordance to MEDDEV. 2.12/2 rev. 2.• Transition from Medical Devices Directive (MDD) to Medical Devices Regulation (MDR) regarding Biological Safety and Clinical Evaluation issues.• Summary of Safety and Clinical Performance (SSCP) in accordance with the Medical Devices Regulation (MDR). Show less
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Biological Safety Specialist
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May 2016 - Apr 2018
• Systhematic literature search of materials, manufacturing processes, and clinical data of medical devices.• Biocompatibility testing request and critical analysis of the results.• Biological Safety Assessment in accordance to ISO 10993-1.• Toxicological Analysis in accordance to ISO 10993-17.• Clinical Evaluation (CEP/CER) in accordance to MEDDEV. 2.7/1 rev. 4.• Support to Regulatory Affairs in clinical and biocompatibility issues.
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Universidade Federal do Paraná
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Brazil
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Higher Education
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700 & Above Employee
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MSc/PhD Student
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Mar 2010 - Feb 2016
• Study the role of glutathione in the guanine oxidation by singlet oxygen mechanism. • Biochemistry lab classes for the Dentistry students. • Literature review. • Buffer solutions preparation. • Chemical synthesis. • HPLC and HPLC/micrOTOF analyzes. • DNA handling and electrophoresis. • Statistical analysis. • Results presentation. • Publication: "Glutathione modifies the oxidation products of 2'-deoxyguanosine by singlet molecular oxygen" and "Synthesis of 8-oxo-7,8-dihydro-2 ́-deoxyguanosine from 2 ́-deoxyguanosine using Cu(II)/H2O2 /ascorbate: A new strategy for an improved yield". Show less
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UEL - Universidade Estadual de Londrina
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Brazil
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Higher Education
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700 & Above Employee
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Research Intern
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Aug 2004 - Dec 2007
Free Radicals Lab (Pathology Department). • Study of oxidative stress parameters associated to cancer cachexia. • Study of chronological aging and photoaging. • Literature review. • Wistar rats and HRS/J mice handling in accordance with animal ethics committee. • Measurement of catalase, glutathione and superoxide dismutase activities. • Measurement of lipid oxidation and carbonyl proteins. • Measurement of chemiluminescence of oxidized skin. • Measurement of the total antioxidant capacity (TRAP) by chemiluminescence. • Statistical analysis. • Results presentation. • Publication: "Photoaging and chronological aging profile: Understanding oxidation of the skin". Show less
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Education
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2013 - 2020
Universidade Federal do Paraná
Bachelor of Engineering (BEng), Mechanical Engineering -
2012 - 2016
Universidade Federal do Paraná
Doctor of Philosophy (PhD), Biochemistry -
2010 - 2012
Universidade Federal do Paraná
Master of Science (MSc), Biochemistry -
2004 - 2008
UEL - Universidade Estadual de Londrina
Bachelor of Applied Science (BASc), Biomedical Sciences -
2001 - 2002
Pigeon Forge High School
High School
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