プロフィール詳細

プロジェクトを作成

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Dr. Ana Luiza C.に依頼

Brazil

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences

プロフィール概要

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in the National Health Surveillance Agency (Anvisa) and CE Marking Certification (MDD 93/42/EEC and MDR 2017/745). I have experience in routinely preparing a Post-Market Surveillance Plan and Report (PMS), Clinical Evaluation Plan and Report (CER, according to MEDDEV 2.7/1-Rev.4), Biological Evaluation Plan and Report (BER, according to ISO 10993), Risk Management File (according to ISO 14971), Post-Market Clinical Follow-up Plan and Report (PMCF, according to MEDDEV 2.12-2); Clinical Investigation Protocol (CIP, according to Good Clinical Practices ISO 14155, MDD 93/42/EEC, MDR 2017/745) and Instruction for the Use of implantable Medical Devices classes IIb and III, according to Medical Device Regulations MDD 93/42/EEC and MDR 2017/745. I have the experience to register raw material, bovine pericardium, in the European Directorate for Quality of Medicines (EDQM). I hold a Bachelor's degree in Biology, from the Federal University of Ouro Preto, a Master’s degree in Cellular Biology from the Federal University of Minas Gerais, and a Doctor's degree in Immunobiology of Protozoa from the Federal University of Ouro Preto. Various scientific articles published.

専門分野

• ★ Post-Market Surveillance
• ★ Clinical Evaluation Reports (CER)
• ☆ Medical Devices
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Clinical Laboratory Science
• ☆ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Investigational Device Exemption (IDE)
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Medical Writing
• ☆ Technical & Scientific Writing
• ☆ SOP & Protocol Writing
• ☆ Science Communication

サービス

• Writing
• Research
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Data & AI Data Visualization

Product Development Stability/Shelf Life Testing

職務経験

Clinical Specialist

Mediphacos Indústrias Médicas S.A.

5月 2019 - 現在

Quality Analyst

Cmos Drake S.A.

10月 2018 - 4月 2019

Quality and Regulatory Affair Manager

Comex Indústrias Médicas S.A.

1月 2017 - 9月 2018

Clinical Research and Regulatory Affairs

Labcor Laboratórios Ltda

1月 2013 - 12月 2016

Lab experience (Doctorate degree in protozoan immunoparasitology)

Universidade federal de Ouro Preto

3月 2010 - 3月 2015

Lab experience (Master degree in cell biology)

Universidade Federal de Minas Gerais

7月 2007 - 6月 2009

Lab experience (Bachelor degree in biological sciences)

Universidade federal de Ouro Preto

9月 2003 - 6月 2007

学歴

Doctorate degree in protozoan immunoparasitology

Universidade Federal de Ouro Preto

3月 2010 - 3月 2015

MBA Quality Management

Universidade FUMEC

7月 2014 - 2月 2015

Master degree in cell biology

Universidade Federal de Minas Gerais

7月 2007 - 6月 2009

Bachelor degree in biological sciences

Universidade Federal de Ouro Preto

9月 2003 - 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

Campos CF, Cangussú SD, Duz ALC, Cartelle CT, Noviello ML, Veloso VM, Bahia MT, Almeida-Leite CM, Arantes RME(2017). Correction: Enteric Neuronal Damage, Intramuscular Denervation and Smooth Muscle Phenotype Changes as Mechanisms of Chagasic Megacolon: Evidence from a Long-Term Murine Model of Tripanosoma cruzi Infection . PloS one.

Campos CF, Cangussú SD, Duz AL, Cartelle CT, Noviello Mde L, Veloso VM, Bahia MT, Almeida-Leite CM, Arantes RM(2016). Enteric Neuronal Damage, Intramuscular Denervation and Smooth Muscle Phenotype Changes as Mechanisms of Chagasic Megacolon: Evidence from a Long-Term Murine Model of Trypanosoma cruzi Infection . PloS one.

Duz AL, Vieira PM, Roatt BM, Aguiar-Soares RD, Cardoso JM, Oliveira FC, Reis LE, Tafuri WL, Veloso VM, Reis AB, et al.(2014). The TcI and TcII Trypanosoma cruzi experimental infections induce distinct immune responses and cardiac fibrosis in dogs . Memorias do Instituto Oswaldo Cruz.

Côrtes DF, Carneiro MB, Santos LM, Souza TC, Maioli TU, Duz AL, Ramos-Jorge ML, Afonso LC, Carneiro C, Vieira LQ(2010). Low and high-dose intradermal infection with Leishmania major and Leishmania amazonensis in C57BL/6 mice . Memorias do Instituto Oswaldo Cruz.